RECENT PUBLICATIONS
-
âIn silico prediction of pharmaceutical degradation pathways: a benchmarking study using the software program Zeneth
-
âAssessing the relevance of solution phase stress testing of solid dosage form products: a cross-industry benchmarking studyâ, J. Pharm. Sci., 111:2, 298-305 (2022)
-
âAddressing the complex problem of degradation-derived mutagenic impurities in drug substances and productsâ, in Mutagenic Impurities: Strategies for Identification and Control, 2nd Edition
-
âMutagenic Impuritiesâ, in Specification of Drug Substances and Drug Products: Development and Validation of Analytical Methods, Second Edition
-
âNew Developments in the Pharmaceutical Stress Testing (Forced Degradation) Industry Practices: A Landmark Benchmarking Studyâ, European Pharmaceutical Review, Issue 6, December (2021)
- Degradation Rate Observations as a Function of Drug Load in Solid-State Drug Products
- The Degradation Chemistry of Prasugrel Hydrochloride: Part 1âDrug Substance
- Degradation Rate Observations as a Function of Drug Load in Solid State Drug Products (2019)
- Impurity Investigations by Phases of Drug and Product Development (2018)
- Determination of Deg Chem of Pemetrexed (2016)
- Artifactual degradation.amine.nitrite.published (2018)
- Impurity investigations.phase of development (2017)
- Mechanistic studies.N-formylation.Edivoxetine (2017)
- Determination of the Degradation Chemistry of the Antitumor Agent Pemetrexed Disodium
- Artifacts Generated During Azoalkane Peroxy Radical Oxidative Stress Testing of Pharmaceuticals Containing Primary and Secondary Amines
- Assessing the Risk of Formation of Potential Genotoxic Degradation Products in a Small-Molecule Kinase Inhibitor Drug Substance and Drug Product
- Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 2: Topical Drug Product
- Strategies To Address Mutagenic Impurities Derived from Degradation in Drug Substances and Drug Products
- Why Should We Care About Publishing?
REFEREED / PEER REVIEWED
-
Hemingway R, Baertschi SW, Benstead DJ, Campbell JM, Coombs MK, Huang Z, Khalaf R, Ott MA, Reid DL, Stevenson NG, Webb SJ, White AT, Zelesky TC, âIn silico prediction of pharmaceutical degradation pathways: a benchmarking study using the software program Zeneth, Mol. Pharm., submitted.Â
-
Campbell JM,* Foti C,* Wang C, Adams N, Allain LR, Araujo G, Azevedo R, Ribeiro-Franca J, Hicks SR, Hostyn S, Jansen PJ, Kotoni D, Kuemmell A, Marden S, Rullo G, Ana ClĂĄudia O Santos, Sluggett GW, Zelesky T, Baertschi SW, âAssessing the relevance of solution phase stress testing of solid dosage form products: a cross-industry benchmarking studyâ, J. Pharm. Sci., 111:2, 298-305 (2022). https://www.sciencedirect.com/science/article/abs/pii/S0022354921003026.
-
Baertschi SW, Teasdale A, âAddressing the complex problem of degradation-derived mutagenic impurities in drug substances and productsâ, in Mutagenic Impurities: Strategies for Identification and Control, 2nd Edition, Teasdale A, Editor, Wiley, New Jersey, USA (2020).
-
Baertschi SW*, Olsen BA, âMutagenic Impuritiesâ, in Specification of Drug Substances and Drug Products: Development and Validation of Analytical Methods, Second Edition, Riley CM, Rosanske TW, Reid GL, Editors, Elsevier, New York (2019).
-
Foti C, Campbell JM, Firmino FC, Claudia O. Santos A, Baertschi SW, âNew Developments in the Pharmaceutical Stress Testing (Forced Degradation) Industry Practices: A Landmark Benchmarking Studyâ, European Pharmaceutical Review, Issue 6, December (2021).
- Baertschi SW,* Maxwell-Backer L, Clemens M, Smitka TA, Draper JR, Taylor KW, Kaerner A, and Jansen PJ,* âThe degradation chemistry of prasugrel hydrochloride. Part 1. Drug substance, J. Pharm. Sci., 108:9, 2842-2857 (2019). https://doi.org/10.1016/j.xphs.2019.04.008
- Baertschi SW, Dill AL, Kramer TT,* Scrivens G,* and Suruzhon M, âDegradation rate observations as a function of drug load in solid state productsâ, J. Pharm. Sci.,108, 1746-1755 (2019). https://doi.org/10.1016/j.xphs.2018.12.003.
- Olsen BA,* Sreedhara A, and Baertschi SW, âImpurity investigations by phases of drug and product developmentâ, Trends in Analytical Chemistry, 101, 17-23 (2018). https://doi.org/10.1016/j.trac.2017.10.025
- Sluggett G,* Zelesky T, Hetrick E, Babayan Y, and Baertschi SW, âArtifactual degradation of secondary amine containing drugs during accelerated stability testing when saturated sodium nitrite solutions are used for humidity controlâ, J. Pharm. Biomed. Anal., 149, 206-213 (2018). https://doi.org/10.1016/j.jpba.2017.10.035
- Neflui M,* Foti C,* Zelesky T, Sluggett G, Jansen PJ, Baertschi SW, and Harmon PA, âArtifacts Generated During Azoalkane Peroxy Radical Oxidative Stress Testing of Pharmaceuticals Containing Primary and Secondary Aminesâ, J. Pharm. Sci., 104: 12, 4287-4298 (2015). Nov 13: DOI: 10.1002/jps.24667.
- Hoaglund Hyzer C,* Williamson ML, Jansen PJ, Montgomery RM, Kopach ME, Scherer RB, and Baertschi SW, âMechanistic Studies of the N-Formylation of Edivoxetine, a Secondary Amine-Containing Drug, in a Solid Oral Dosage Formâ, J. Pharm. Sci., DOI: 10.1016/j.xphs.2017.01.026.
- Jansen PJ,* Smith WK, Dorman DE, Kemp CAJ, McCune KA, Baertschi SW,* âDetermination of the Degradation Chemistry of the Anti-Tumor Agent Pemetrexed Disodiumâ, J. Pharm. Sci., 105:11, 3256-3268 (2016). http://dx.doi.org/10.1016/j.xphs.2016.06.029
- Baertschi SW,* Olsen BA, Wozniak TJ, Toltl N, OâShea C, Jansen PJ, âFormation of copper (I) from trace levels of copper (II) as an artifactual impurity in the HPLC analysis of olanzapineâ, J. Pharm. Biomed. Anal., DOI:10.1016/j.jpba.2016.03.040.
- Allain L, Baertschi SW, Clapham D,* Foti C, Lantaff WM, Reed RA, Templeton AC,* and Tonnesen, HH, âImplications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products Part 3. Oral Drug Productsâ, J. Pharm. Sci., DOI: 10.1002/jps.24396.
- Zhang T, and Baertschi SW, ââŹĹWhy Should We Care About Publishing?ââŹÂ,Ă Org. Proc. Res. Dev. 2015, 19, 559âËâ560.
- Kleinman MH*, Elder D, Teasdale A, Mowery M, McKeown A, and Baertschi SW*, Strategies to Address Mutagenic Impurities Derived from Degradation in Drug Substances and Drug Products,  Org. Proc. Res. Dev., 19:11, 1447-1457 (2015), DOI: 10.1021/acs.oprd.5b00091.
- Strege M, Osborne L, Hetrick E, Dill, A, Jansen PJ, Draper JR, Montgomery RM, Buser J, Smitka T, Pack B, Baertschi SW, âAssessing the Risk of Formation of Potential Genotoxic Degradation Products in a Small-Molecule Kinase Inhibitor Drug Substance and Drug Productâ, Org. Proc. Res. Dev., 19:11, 1458-1464 (2015), DOI: 10.1021/acs.oprd.5b00112.
- Nefliu M,* Foti C,* Zelesky T, Sluggett G, Jansen PJ, Baertschi SW, and Harmon PA, âArtifacts Generated During Azoalkane Peroxy Radical Oxidative Stress Testing of Pharmaceuticals Containing Primary and Secondary Aminesâ, J. Pharm. Sci., 104: 12, 4287-4298 (2015). Nov 13: 10.1002/jps.24667.
- Kleinman MH*, Elder D, Teasdale A, Mowery M, McKeown A, and Baertschi SW*, Strategies to Address Mutagenic Impurities Derived from Degradation in Drug Substances and Drug Products,  Org. Proc. Res. Dev., 19:11, 1447-1457 (2015), DOI: 10.1021/acs.oprd.5b00091.
- Strege M, Osborne L, Hetrick E, Dill, A, Jansen PJ, Draper JR, Montgomery RM, Buser J, Smitka T, Pack B, Baertschi SW, âAssessing the Risk of Formation of Potential Genotoxic Degradation Products in a Small-Molecule Kinase Inhibitor Drug Substance and Drug Productâ, Org. Proc. Res. Dev., DOI: 10.1021/acs.oprd.5b00112.
- Baertschi SW, Clapham D,* Foti C, Kristensen S, Reed RA, Templeton AC,* Tonnesen HH. Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products. Part 2. Topical Drug Products, J. Pharm. Sci., DOI.10.1002/jps.24396 (2015).
- Baertschi SW, Clapham D,* Foti C, Kristensen S, Reed RA, Templeton AC,* Tonnesen HH. Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products. Part 2. Topical Drug Products, J. Pharm. Sci., 102:11, 3888-3899 (2015), DOI.10.1002/jps.24396 (2015).
-  Kleinman MH,* Baertschi SW, Alsante KM, Reid DL, Mowery MD, Shimanovich R, Foti C, Smith WK, Reynolds DW, Nefliu M, and Ott MA. âIn Silico Prediction  of Pharmaceutical Degradation Pathways: A Benchmarking Studyâ, Mol. Pharm,11, 4179-4188 (2014).
-  Alsante KM, Huynh-Ba K, Reed RA, Baertschi SW, Landis M, Furness S, Olsen BA, Mowery M, Russo K, Isler R, Stephenson GA, and Jansen PJ., âRecent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2. Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscapeâ, AAPS PharmSciTech, 15:1, (2014) 237-251.
-  Gorog, S., and Baertschi, SW, âThe Role of Analytical Chemistry in Drug-Stability Studiesâ, Trends in Analytical Chemistry, 49, 55-56 (2013).
-  Alsante KM, Huynh-Ba K, Reed RA, Baertschi SW, Landis M, Kleinman M, Foti C, Rao VM, Meers P, Abend A, Reynolds DW, and Joshi BK, âRecent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms â, AAPS PharmSciTech, 15(1), 198-212 (2013).
-  Baertschi SW*, Jansen PJ, Montgomery RM, Smith WK, Draper JR, Myers DP, Houghton PG, Sharp VS, Guisbert AL, Zhuang H, Watkins MA, and Harris TM, âInvestigation of the Mechanism of Racemization of Litronesib in Aqueous Solution: Unexpected Base-Catalyzed Inversion of a Fully-Substituted Carbon Chiral Centerâ, J.Pharm.Sci, 103:2797â2808 (2014).
-  Myers DP*, Hetrick EM, Zhongming L, Hadden CE, Bandy S, Kemp CAJ, Harris TM, Baertschi SW, âOn-Column Nitrosation of Amines Observed in HPLC Impurity Separations Employing Ammonium Hydroxide and Acetonitrile as Mobile Phaseâ, J. Chrom. A., 1319, 57-64 (2013).
-  Baertschi SW,* Clapham D,* Foti C, Jansen PJ, Kristensen S, Reed RA, Templeton AC, Tonnesen HH. Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 1: Drug Products Administered by Injection, J. Pharm. Sci. 102:11, 3888-3899 (2013).
-  Baertschi SW,* Pack BW, Hoaglund-Hyzer CS, and Nussbaum MA, âAssessing Mass Balance in Pharmaceutical Drug Products: New Insights into an Old Topicâ, Trends in Analytical Chemistry, 49, 126-136 (2013).
-  Dow LK,* Pack BW, Hansen MM, and Baertschi SW, âThe Assessment of Impurities for Genotoxic Potential and Subsequent Control in Drug Substance and Drug Productâ, J. Pharm. Sci., Commentary, 102(4), 1404-1418 (2013).
-  Raillard SP, Bercu J, Baertschi SW, and Riley CM, âPrediction of Drug Degradation Pathways Leading to Structural Alerts for Potential Genotoxic Impuritiesâ, Org. Proc. Res. and Dev., 14, 1015-1020 (2010).
-  Baertschi SW, Alsante KM, and Tønnesen HH, âA Critical Assessment of the ICH Guideline on Photostability Testing of New Drug Substances and Products (Q1B): Recommendation for Revisionâ, J. Pharm. Sci., 99:7, 2934-2940 (2010).
-  Skibic MJ, King LA, Khan M, Fox PJ, Winger BE, and Baertschi SW* âArtifactual Formylation of Duloxetine Hydrochloride by Acetonitrile in the Presence of Titanium Dioxide and Ultrasonication: Implications for HPLC Method Developmentâ, J. Pharm. Biomed. Anal.,53, 432-439 (2010).
-  Baertschi SW,* Brunner H, Bunnell CA, Cooke GG, Diseroad B, Dorman DE, Jansen PJ, Kemp CAJ, Maple SR, McCune KA, and Speakman JL, âIsolation, Identification, and Synthesis of Two Degradation Products of Olanzapine (LY170053)â, J. Pharm. Sci., 97:2, 883-892 (2008).
-  Baertschi SW*, âAnalytical Methodologies for Discovering and Profiling Degradation-Related Impuritiesâ, Trends in Analytical Chemistry, 25:8, 758-767 (2006).
-  Nussbaum MA,* Baertschi SW, and Jansen PJ, âDetermination of Relative UV Response Factors by use of a Chemiluminescent Nitrogen-Specific HPLC Detectorâ, J. Pharm. Biomed. Anal., 27, 983-993 (2002).
-  Thatcher SR,* Mansfield RK, Miller RB, Davis CW, and Baertschi SW,* âPharmaceutical Photostability:  A Technical and Practical Interpretation of the ICH Guideline and Its Application to Pharmaceutical Stability: Part IIâ, Pharmaceutical Technology, 25:4, pp. 50-62, April (2001).
-  Thatcher SR,* Mansfield RK, Miller RB, Davis CW, and Baertschi SW,* âPharmaceutical Photostability:  A Technical and Practical Interpretation of the ICH Guideline and Its Application to Pharmaceutical Stability: Part Iâ, Pharmaceutical Technology, 25:3, pp. 98-110, March (2001).
-  Baertschi SW,* Kinney H., and Snider BG., âIssues in Evaluating the âIn-Useâ Photostability of Transdermal Patchesâ, Pharmaceutical Technology, Sept. 70-80 (2000).
-  Allen JM,* Allen SK, and Baertschi SW, â2-Nitrobenzaldehyde: A Convenient UV-A and UV-B Chemical Actinometer for Drug Photostability Testingâ, J. Pharm. Biomed. Anal., 24, 167-178 (2000).
-  Jansen PJ,* Akers MJ, Amos RM, Baertschi SW, Cooke GG, Dorman DE, Kemp CAJ, Maple SR, and McCune KA. âThe Degradation of the Anti-Tumor Agent Gemcitabine Hydrochloride in an Acidic Aqueous Solution and Identification of the Degradation Productsâ, J. Pharm. Sci., 89:7, 885-891 (2000).
-  Hartauer K.,* Arbuthnot G., Baertschi SW, Johnson R, Luke W, Pearson N, Rickard E, Tsang P, and Wiens R. âInfluence of Peroxide Impurities in Povidone and Crospovidone on the Tablet Stability of Raloxifene Hydrochloride. Identification and Control of an Oxidative Degradation Productâ, Pharmaceutical Development and Technology, 5:3, 303-319 (2000).
-  Wirth DD,* Baertschi SW, Johnson RA, Maple SR, Miller MS, Hallenbeck DK, and Gregg SM, âMaillard Reaction of Lactose and Fluoxetine Hydrochloride, a Secondary Amineâ, J. Pharm. Sci., 87:1, 31-39 (1998).
- Jansen PJ*, Oren PL, Kemp CAJ, Maple SR, and Baertschi SW*, âCharacterization of Impurities Formed by Interaction of Duloxetine HCl with Enteric Polymers Hydroxypropyl Methylcellulose Acetate Succinate (HPMCAS) and Hydroxypropyl Methylcellulose Phthalate (HPMCP)â, J. Pharm. Sci., 87:1, 81-85 (1998).
-  Baertschi SW* âCommentary on the Quinine Actinometry System Described in the ICH Draft Guideline on Photostability Testing of New Drug Substances and Productsâ Drug Stability, 1:4, 193-195 (1997).
- Dorman DE,* Lorenz LJ, Occolowitz JL, Spangle LA, Collins MW, Bashore, FN, and Baertschi, SW.  âIsolation and Structure Elucidation of the Major Degradation Products of Cefaclor in the Solid Stateâ, J. Pharm. Sci., 86:5, 540-549 (1997).
- Baertschi SW,* Dorman DE, Occolowitz JL, Spangle LA, Collins MW, Bashore FN, and Lorenz LJ.  âIsolation and Characterization of the Major Degradation Products Arising from Aqueous Degradation of Cefaclorâ, J. Pharm. Sci., 86:5, 526-539 (1997).
-  Baertschi SW,* Boyd DB, Cantrell AS, Jaskunas SR, Kuhfeld MT, and Lorenz LJ. âInhibition of HIV-1 Reverse Transcriptase by Degradation Products of Ceftazidimeâ Antiviral Chemistry and Chemotherapy, 8:4, 353-362 (1997).
- Baertschi SW,* Dorman DE, Spangle LA, Lorenz LJ, Collins MW, and Occolowitz JL. âFormation of Fluorescent Pyrazine Derivatives via a Novel Degradation Pathway of the Carbacephalosporin Loracarbefâ, J. Pharm. Biomed. Anal., 13:3, 323-328 (1995).
-  Olsen BA,* Baertschi SW, and Riggin RM.  âMultidimensional evaluation of impurity profiles for generic cephalexin and cefaclor antibioticsâ, J. Chromatography, 648, 165-173 (1993).
- Skibic M, Taylor KW, Occolowitz JL, Collins MW, Paschal J, Lorenz LJ, Spangle LA, Dorman DE, and Baertschi SW.* âAqueous Acidic Degradation of the Carbacephalosporin Loracarbefâ, J. Pharm. Sci., 82:10, 1010-1017 (1993).
-  Baertschi SW,* Dorman DE, Occolowitz JL, Spangle LA, Collins MW, and Lorenz LJ. âIsolation and Structure Elucidation of a Novel Product of the Acidic Degradation of Cefaclorâ, J. Pharm. Sci., 82, 622-626 (1993).
-  Song W.-C., Baertschi SW, Boeglin, WE, Harris TM, and Brash AR.*  âFormation of Epoxyalcohols by a Purified Allene Oxide Synthase: Implications for the Mechanism of Allene Oxide Synthesisâ, J. Biol. Chem. 268, 6293-6298 (1993).
-  Brash AR,* Baertschi SW, and Harris TM.  âFormation of Prostaglandin A Analogues Via an Allene Oxideâ, J. Biol. Chem.265, 6705-6712 (1990).
- Harris TM,* Stone MP, Gopalakrishnan S., Baertschi SW., Raney KD, and Byrd S. âAflatoxin B1 Epoxide, the Ultimate Carcinogenic Form of Aflatoxin B1: Synthesis and Reaction with DNAâ J. Toxicol.-Toxin Reviews 8 (1&2), 111-120 (1989).
-    Atsmon J, Sweetman BJ, Baertschi SW, Harris TM, and Roberts L.J. II* âFormation of Thiol Conjugates of 9-Deoxy-D9,D12(E)-prostaglandin D2 and D12(E)-Prostaglandin D2âł, Biochemistry 29, 3760-3765 (1990).
- Baertschi SW. Ph.D. âChemical and Biological Studies of Aflatoxins and Prostanoidsâ, Ph.D. Thesis, Avail. Univ. Microfilms Int., Order No. DA9006837, 178 pp. (1989)
- Baertschi SW,* Brash AR, Harris TM.  âFormation of a Cyclopropyl Eicosanoid via an Allene Oxide in the coral Plexaura homomalla:  Implications for the Biosynthesis of 5,6-trans-PGA2âłÂ J. Am. Chem. Soc., 111, 5003-5005 (1989).
-    Baertschi SW, Raney KD, Shimada T, Harris TM, and Guengerich FP*  âComparison of Rates of Enzymatic Oxidation of Aflatoxins B1, G1, and Sterigmatocystin and Reactivities of the 8,9-Epoxide in Forming N7-Guanyl Adducts and Inducing Various Genetic Responsesâ Chem. Res. Toxicol., 2, 114-122 (1989).
-    Baertschi SW,* Raney KD, Stone MP, and Harris TM.  âPreparation of the 8,9-epoxide of the Mycotoxin Aflatoxin B1; the Ultimate Carcinogenic Speciesâ  J. Am. Chem. Soc., 110, 7929-7931 (1988).
-    Brash AR,* Baertschi SW, Ingram CD, and Harris TM. (1988) âIsolation and Characterization of Natural Allene Oxides: Unstable Intermediates in the Metabolism of Lipid Hydroperoxidesâ  Proc. Natl. Acad. Sci. USA, 85, 3382-3386 (1988).
-    Baertschi SW, Ingram CD, Harris TM, and Brash AR.* (1988) âAbsolute Configuration of cis-12-Oxophytodienoic Acid of Flaxseed:  Implications for the Mechanism of Biosynthesis from the 13(S)-Hydroperoxide of Linolenic Acidâ  Biochemistry, 27, 18-24 (1988).
-    Brash AR,* Baertschi SW, Ingram CD, and Harris TM. (1987) âOn Non-Cyclooxygenase Prostaglandin Synthesis in the Sea Whip Coral, Plexaura Homomalla: An 8(R)-Lipoxygenase Pathway Leads to Formation of an a-Ketol and a Racemic Prostanoidâ  J. Biol. Chem., 262, 15829-15839 (1987).
*Corresponding author(s)
POSTERS, ORAL PRESENTATIONS, AND PUBLISHED ABSTRACTS
- Baertschi SW,* âN-Nitrosamines: Chemistry and Risk Assessment in Formulated Productsâ, virtual presentation at the Nitrosamines Workshop, hosted by Treffen, Oct. 21 (2020).
- Baertschi SW,* âPredictability of Forced Degradation Studies for Real World Stabilityâ, International Pharmaceutical Academy, Virtual Stability Program Conference, Oct. 21 (2020).
- Baertschi SW,* âShining Some Light into the ICH Q1B Guideline on Photostablityâ, International Pharmaceutical Academy, Virtual Stability Program Conference, Oct. 21 (2020).
- Baertschi SW,* âChemistry and Risk Assessment of N-Nitrosaminesâ, PDA Webinar, Aug 27 (2020).
- Baertschi SW,* âLight-Induced Reactivity Assessments: Implications for Practical Photostability and Phototoxicity Potentialâ, AAPS Webinar, June 11 (2020).
- Baertschi SW,* âDrug Photostability: The Science and Application of Photo- Produced Reactive Oxygen Speciesâ, presented at the Science of Stability Conference, hosted by Freethink Technologies, Amsterdam, NE, October 14-15 (2019).
- Baertschi SW,* âForced Degradation in Stability-Indicating Method Developmentâ, presented at the Pharmaceutical Impurities Symposium, hosted by Mikromol / LGC Group, June 19 (2019).
- Baertschi SW,* âThe Chemistry of Drug Degradation: Fundamentals of Oxidative Degradationâ, presented at the Pharmaceutical Impurities Symposium, hosted by Mikromol / LGC Group, June 19 (2019).
- Baertschi SW,* âThe Chemistry of Drug Degradation: Triggers for Degradationâ, presented at the Pharmaceutical Impurities Symposium, hosted by Mikromol / LGC Group, June 19 (2019).
- Baertschi SW*, âThe Chemistry of Drug Degradation: Fundamentals of Oxidative Degradationâ, presented at Catalent Pharma Solutions, St. Petersburg, FL, May 2 (2019).
- Baertschi SW*, âSpeeding Drug Development Through State-of-the-Art Impurity Control Strategiesâ, webinar, sponsored by Regis Technologies, Inc., presented Nov 15 (2018).
- Baertschi SW*, âThe Foundational Role of Forced Degradation in Stability- Indicating Method Development: Potential Pitfallsâ, presented at Eastern Analytical Symposium, Princeton, NJ, Nov 12 (2018).
- Baertschi SW, âStrategic Approaches to Development of Phase-Appropriate Specifications Including Organic Impurities Controlâ, presented at AAPS PharmSci360, Washington, DC, Nov 7 (2018).
- Baertschi SW and Jansen PJ, âThe Remarkably Complex Degradation Chemistry of Prasugrel Hydrochlorideâ, presented at Science of Stability, Boston, MA, Oct 23 (2018).
- Baertschi SW, âSpeeding Drug Development Through State-of-the-Art Impurity Control Strategiesâ, presented at Regis Technologies, Morton Grove, IL, Oct 17; South San Francisco, CA, Oct 31; LaJolla, CA, Nov 1 (2018)
- Baertschi SW, âICH M7 Overview: Predicting, Assessing, and Controlling Mutagenic Impurities from Degradationâ, presented at the Lhasa 2018 Pharmaceutical Industry and Regulators Symposium, Brasilia, Brazil, May 25 (2018).
- Baertschi SW, âDrug Degradation Mechanisms: Are They Important?â, presented at Forced Degradation Analytical session, paper 2849635, ACS National Meeting, New Orleans, LA, March 21 (2018).
- Baertschi SW, âDrug Stability Testing: Destroying Drugs for the Purpose of Bringing Them to Marketâ, presented to Southern California Pharmaceutical Discussion Group, March 15, Orange County, CA (2018).
- Baertschi SW, âFrom Stress Degradation to Stability: Analytics and API Developmentâ, presented at Pharmaceutical Impurities Day, sponsored by Averica/Neopharm, Nov 30, Montreal, CA (2017).
- Baertschi SW, âAnalytical Life Cycle Management: Case Studiesâ, presented at the Sunrise School workshop on Analytical Life Cycle Management, AAPS Annual Meeting, Nov 15, San Diego, CA (2017)
- Baertschi SW, âFrom Stress Degradation to Stability: Analytics and API Developmentâ, presented at AAPS Annual Meeting, Nov 14, San Diego, CA (2017).
- Baertschi SW, âDrug Degradation Mechanisms: Why Are They Important?â, Webinar, hosted by Crystal Pharmatech, Oct 18 (2017).
- Baertschi SW, âFrom Stress Degradation to Stability: Analytics and API Developmentâ, presented at Pharmaceutical Impurities Day, sponsored by MassBio and Averica/Neopharm, Cambridge, MA Oct. 30 (2017).
- Baertschi SW, âShining Some Light into the ICH Q1B Guideline on Photostabilityâ, presented at the ICH Stability Training Workshop, Northeastern University, Burlington, MA, Oct 11-13 (2017).
- Baertschi SW, âThe Chemistry of Drug Degradation â Fundamentals of Oxidative Degradationâ, Science of Stability Conference, Dublin, Ireland, Oct 3-5 (2017).
- Baertschi SW, The Chemistry of Drug Degradation, 1.5-day workshop presented at USP Convention Headquarters, Rockville, MD, June 28-29 (2017).
- Baertschi SW and Allain L, âIn-Use Photostability: Considerations for Topical and Injectable Productsâ, AAPS Workshop on Stability Challenges Not Address by Harmonized Guidance, Rockville, MD, April 3-4 (2017).
- Baertschi SW, âPredictability of Forced Degradation Studies for Real World Stabilityâ, presented at Sindusfarma workshop on Degradation Products and Qualification, Sao Paulo, Brazil, Oct 24-25 (2016).
- Baertschi SW, âDrug Degradation Mechanisms: Why Are They Importantâ, Science of Stability conference, Newark, NJ, Sept 25-27, 2016.
- Baertschi SW, âPredicting, Assessing, and Controlling Mutagenic Impurities
from Degradationâ, Land OâLakes Conference on Pharmaceutical Analysis, Madison, WI, Aug 1-4, 2016. - Baertschi SW, âAssessing the Impact of Mutagenic Impurities Regulationsâ, Waters/ CERSI Conference on Ensuring Drug Quality, Baltimore, MD, May 18-19, 2016.
- Baertschi, SW, DeAntonis D, Mowery M, and Scott B, âICH M7 and Mutagenic Impuritiesâ, AAPS Joint Focus Group Face-to-Face Meeting, Gaithersburg, MD, April 6 (2016).
- Baertschi SW, âMutagenic Degradation Products: Theoretical and [Semi]Empirical Approaches for Predicting, Discovering, and Controllingâ, AAPS Stability Workshop, USP Headquarters, Rockville, MD April 4-5, 2016,
- Baertschi SW, âMutagenic Degradation Products: Risk Assessment and Controlâ, AAPS Workshop on Mutagenic Impurities, AAPS Annual Meeting, Orlando, FL, Oct 25, 2015.
- Dill AL, Baertschi SW, Kramer T, and Sperry DC, âPredicting the Degradation Rate as a Function of Drug Load in Solid-State Drug Productsâ, Science of Stability Conference, Mashantucket, CT, Oct 12-14, 2015.
- Baertschi SW, âFundamental of Predicting Oxidative Degradation Productsâ, Science of Stability Conference, Mashantucket, CT, Oct 12-14, 2015.
- Baertschi SW, âIn Silico Prediction of Degradation Chemistryâ, Science of Stability Conference, Mashantucket, CT, Oct 12-14, 2015.
- Baertschi SW, âIn-Use Photostability: Injectablesâ, Photostability 2015, Academy of Pharmaceutical Sciences of Great Britain, Loughborough, UK Oct 5, 2015.
- Baertschi SW, âUnexpected Photoinstability: Compounds With No Apparent Absorption of Light!?â, Photostability 2015, Academy of Pharmaceutical Sciences of Great Britain, Loughborough, UK Oct 5, 2015.
- Baertschi SW, âFundamentals of Photochemistry and Photostability Testingâ, Photostability 2015, Academy of Pharmaceutical Sciences of Great Britain, Loughborough, UK Oct 5, 2015.
- Baertschi SW, âPredictablity of Forced Degradation Studies for Real World Stabilityâ, presented at ANVISA reviewer training workshop on âForced Degradationâ, Brasilia, Brazil, Oct 22 (2014).
- Â Baertschi SW, âPredictablity of Forced Degradation Studies for Real World Stabilityâ, presented at Sindusfarma workshop on âForced Degradationâ, Sao Paulo, Brazil, Oct 20-21 (2014).
- Â Baertschi SW, âOverview of Pharmaceutical Photostability Testingâ, presented at Sindusfarma workshop on âForced Degradationâ, Sao Paulo, Brazil, Oct 20-21 (2014).
- Â Baertschi SW, âFundamentals of Predicting Oxidative Impuritiesâ, presented at Sindusfarma workshop on âForced Degradationâ, Sao Paulo, Brazil, Oct 20-21 (2014).
- Â Dill A, Baertschi SW,* Kramer T, and Sperry DC âPredicting the Degradation Rate as a Function of Drug Load in Solid-State Productsâ, presented at the SES Annual Technical Meeting, âPharmaceutical Solids: Synthesis, Manufacturing, Characterization, and Modelingâ, Purdue University, Oct 3 (2014).
- Â Dill A,* Baertschi SW,* Kramer T, and Sperry DC âPredicting the Degradation Rate as a Function of Drug Load in Solid-State Productsâ, presented at the Conference on Small Molecule Science, Williamsburg, VA, Aug 10 (2014).
- Â Baertschi SW,* âLean Strategies for Conducting Forced Degradation Studies and Downstream Implicationsâ, AAPS Symposium on Stability, AAPS Annual Meeting, Nov 14, San Antonio, TX (2013).
- Â Â Baertschi SW,* âUnexpect Stability Issues Related to Unexpected Impurities from Excipientsâ, AAPS Atypical Impurities Workshop, Nov 9-10, San Antonio, TX (2013).
- Â Baertschi SW,* âLean Stability: Forced Degradation, Real Time Stability, and Analytical Methodologyâ, invited oral presentation at a workshop on Stability for ANVISA, ANVISA Headquarters, Brasilia, Brazil, Oct 2-3 (2013).
- Â Baertschi SW,* âOverview of Pharmaceutical Photostability Testingâ, invited oral presentation at a workshop on Stability for ANVISA, ANVISA Headquarters, Brasilia, Brazil, Oct 2-3 (2013).
- Â Baertschi SW,* McFarland AD, Stephenson GA, âPhysical Stability Issues in Pharmaceutical Developmentâ, invited oral presentation at a workshop on Stability for ANVISA, ANVISA Headquarters, Brasilia, Brazil, Oct 2-3 (2013).
- Â Â Baertschi SW,* Forced Degradation, Real Time Stability, and Analytical Methodology, invited oral presentation at the US-FDA, Office of Generic Drugs Training Seminar, Sept 18 (2013).
- Â Dow L,* Pack B, Baertschi SW, Hansen M, Page TJ, âThe assessment of impurities for genotoxic potential and subsequent control in drug substance and drug productâ â oral presentation at 5th Annual Genotoxic Impurities conference, Informa Life Sciences (Berlin), June (2013).
- Â Kopach ME*, Baertschi SW, Kobierski ME, Nguyen Hawk MK, Â Dione A, Â Williamson ML, Hoaglund-Hyzer C, and Jansen PJ, âUnderstanding the pharmaceutically-relevant Maillard reactionâ, invited presentation at Drug Discovery & World Congress, June 3 (2013).
- Â Baertschi, S.W.* and Mowery, M. âICH M7 Guidance on Genotoxic Impurities: Implications for the Analytical Laboratoryâ, invited oral presentation at the 52nd Annual Pharmaceutical Analysis /, Land OâLakes Conference, Aug (2012).
- Â Â Myers DP, Liang Z, Hetrick E, Hadden C, Bandy S, Harris TM, and Baertschi, SW,âOn-column N-nitrosylation of amines observed in high pH HPLC impurity separationsâ, invited oral presentation at Eastern Analytical Symposium, Somerset, NJ, Nov 12-15 (2012).
- Â Foti, C*; Alsante, K; Baertschi, S.W. âThe Chemistry of Drug Degradationâ, 1-day workshop, Eastern Analytical Symposium, Somerset, NJ, Nov 12-15 (2012).
- Â Mowery, MA* and Baertschi, S.W. âPotential Genotoxic Degradants: ICH Working Group Updateâ, invited oral presentation at the AAPS Annual Meeting Preconference Workshop on Predicting and Monitoring Impurities in API and Drug Products, Oct 13-14, 2012.
- Â Â Baertschi, S.W.*, Fundamentals of Predicting Oxidative Impuritiesâ, invited oral presentation at the AAPS Annual Meeting Preconference Workshop on Predicting and Monitoring Impurities in API and Drug Products, Oct 13-14, 2012.
- Â Â Baertschi, S.W.*, âRevisiting Old Concepts: New Insights into the Concept of Mass Balance in Drug Productsâ, invited oral presentation at the AAPS Annual Meeting Preconference Workshop on Predicting and Monitoring Impurities in API and Drug Products, Oct 13-14, 2012.
- Â Kramer TT, Ritcher DW, Jansen PJ, Risley DS, Sharp V.S, and Baertschi SW*, âNew Ways to Visualize the Results of Forced Degradation Studiesâ, invited oral presentation at Conference on Small Molecule Science, Providence, RI, Sept 10, 2012.
- Â Alsante, K*, Baertschi, S.W., and Foti, C., âReviewing Advances in Knowledge of Drug Degradation Chemistryâ, Forced Degradation for Pharmaceuticals, Informa Life Sciences, London, UK, Jan 18-19, 2012.
- Â Baertschi, S.W.,* Dow, L., Hansen, M., and Pack, B., âStress Testing and Degradation-Derived Genotoxic Impurities: Â Scientific, Practical, and Regulatory Considerationsâ, Challenges and Opportunities for the Control of Genotoxic Impurities Symposium, AAPS Annual Meeting, Washington, DC, Oct 26, 2011.
- Â McFarland, A.D.,* Stephenson, G.A., and Baertschi, S.W.*, âChallenges in the Analytical Characterization of Physical Stability Issuesâ, Predicting and Managing Stability Programs with Physical Stability Issues Symposium, AAPS Annual Meeting, Washington, DC, Oct 26, 2011.
- Â Skibic, M.J.*, King, L.A., Khan, M., Fox, P.J., Winger, B.E., and Baertschi, S.W., âArtifactual Formylation of the Secondary Amine of Duloxetine Hydrochloride by Acetonitrile in the Presence of Titanium Dioxide: Implications for HPLC Method Developmentâ, AAPS Stability Workshop, Washington, DC, October 22-23, 2011.
- Â Baertschi, S.W.*, Alsante, K.M., and Tonnesen, H.H., âICH Q1B Photostability Guideline: Time for a Revision?â, AAPS Stability Workshop, Washington, DC, October 22-23, 2011.
- Â Skibic, M.J.*, King, L.A., Khan, M., Fox, P.J., Winger, B.E., and Baertschi, S.W., âArtifactual Formylation of the Secondary Amine of Duloxetine Hydrochloride by Acetonitrile in the Presence of Titanium Dioxide: Implications for HPLC Method Developmentâ, Conference on Small Molecule Science, UNC-Chapel Hill, Aug 2, 2011.
- Â Jansen, P.J.*, Williamson, M., Hoaglund-Hyzer, C., Kopach, M., and Baertschi, S.W. âDrug-Excipient Compatibility: Investigation of the Mechanism of N-Formylation of Amines by Reducing Sugarsâ, Conference on Small Molecule Science, UNC-Chapel Hill, Aug 2, 2011.
- Â Baertschi, S.W.*, Elder, D., Kleinman, M. McKeown, A., Mowery, M., Norwood, D., Teasdale, A., Dow, L., and Pack, B. âStress Testing and Degradation-Derived Genotoxic Impurities: Scientific, Practical, and Regulatory Considerationsâ, Conference on Small Molecule Science, UNC-Chapel Hill, Aug 2, 2011.
- Â Â Pack, B.W.,* Hetrick E., Dow L., Baertschi, S.W., Hansen, M. âOvercoming the hurdles to rapid and accurate prediction of shelf-life and degradation profilesâ, invited oral presentation at âImpuritiesâ, sponsored by Informa Life Sciences, Prague, Czech Republic, Sept. 15, 2011.
- Â Baertschi, S.W.*, âFundamentals of Photochemistry and Photostability Testingâ, USP Workshop, Sao Paulo, Brazil, May 19-20, 2011.
- Â Â Baertschi, S.W.*, âStrategies for Investigation and Control of Degradation-Related Impuritiesâ, USP Workshop, Sao Paulo, Brazil, May 19-20, 2011.
- Â Â Baertschi, S.W.*, Jansen, P.J., Campbell, B.M., and Draper, J.R. âImplementing Automation in the Pharmaceutical Development Laboratory: The Symyx Automated Forced Degradation Systemâ, Symyx Global Symposium, Prague, Czech Republic, May 20, 2008.
- Â Â Baertschi, S.W.,* âThe Foundational Aspects of Predicting Drug Degradationâ, invited oral presentation at the DIA / AAPS co-sponsored CMC Workshop: Translating Science into Successful Regulatory Submissions, Washington, DC, Feb 7-9, 2011.
- Â Â Baertschi, S.W.*, and Jansen, Patrick J. âDegradation or Artifact: Stress Testing Brain Teasersâ, invited oral presentation at theâ5th Annual Conference on Forced Degradationâ, Informa Life Sciences, London, UK, Jan 25-26, 2011.
- Â Â Baertschi, S.W.*, âStress Testing: Predictive or Overkillâ, invited oral presentation at theâ5th Annual Conference on Forced Degradationâ, Informa Life Sciences, London, UK, Jan 25-26, 2011.
- Â Baertschi, S.W.*, âPredicting Drug Degradationâ, invited oral presentation at the AAPS Workshop on Stability Testing in Pharmaceutical Development, New Orleans, LA, November 14, 2010.
- Â Baertschi, S.W.*, Raillard,S., Bercu, J., and Riley, C.M. âPrediction of Drug Degradation Pathways Leading to Structural Alerts for Potential Genotoxic Impuritiesâ, invited oral presentation, Informa Life Sciences Conference on Genotoxic Impurities, June 29, Zurich, Switzerland, 2010.
- Â Baertschi, S.W.* âPatterns and Pathways: Using Chemistry to Guide the Characterization of Drug Degradation Productsâ, invited oral presentation, 6th Annual Forced Degradation Forum, Institute for International Research, Philadelphia, PA, March 15-16, 2010.
- Â Baertschi, S.W.* âDestroying Drugs for the Purpose of Bringing Them to Marketâ, and âWorking as a Scientist in the Pharmaceutical Industryâ, Vanderbilt University, Center in Molecular Toxicology Seminar Series, Nashville, TN, Feb 24, 2010.
- Â Baertschi, S.W.* âPatterns and Pathways: Using Chemistry to Guide the Characterization of Drug Productsâ, invited oral presentation, Eastern Analytical Symposium, Somerset, NJ, November 18, 2009.
- Â Alsante, K.M.*, and Baertschi, S.W.* âThe Chemistry of Drug Degradationâ, One Day Short Course, Eastern Analytical Symposium, Somerset, NJ, November 17, 2009.
- Â Baertschi, S.W.*, invited oral presentation, âPredicting Drug Degradation via in cerebro Knowledge: A Fresh Look at Degradation Pathwaysâ, AAPS Stability Workshop, National Harbor, MD, Sept 24-25, 2009.
- Â Baertschi, S.W.*, Draper, J.R., Jansen, P.J., and Smith, William, K. âOxidative Susceptibility Testing: Rapid, Comprehensive, Screening Techniquesâ, invited oral presentation, 3rd Annual Conference on Forced Degradation, Informa Health Sciences, Brussels, Belgium, Jan 29-30, 2009.
- Â Alsante, K.M.,* and Baertschi, S.W. âChemistry-Guided Approach to Degradation Studiesâ, oral presentation, 3rd Annual Conference on Forced Degradation, Informa Health Sciences, Brussels, Belgium, Jan 29-30, 2009.
- Â Baertschi, S.W.*, and Alsante, K.M.* âThe Chemistry of Drug Degradationâ, 1-Day Organic Master Class, 3rd Annual Conference on Forced Degradation, Informa Health Sciences, Brussels, Belgium, Jan 31, 2009.
- Â Baertschi, S.W.*, âForced Degradation Studies and Genotoxic Impurities: Â Scientific and Regulatory Issuesâ, invited oral presentation, Genotoxic Impurities Conference, hosted by the Institute for International Research, Philadelphia, PA, Dec 8-9, 2008.
- Â Baertschi, S.W.* âFundamentals of Photochemistry and Photostability Testingâ, invited oral presentation, 1-Day short course on Photostability, Photostability 2008, hosted by the Association of Pharmaceutical Scientists of Great Britain, London, UK, Oct 1, 2008.
- Â Smith, W.K., Jansen, P.J., Kiehl, D.E., Behme, R.J., and Baertschi, S.W.* âDrug Photodegradation in the Solid State: Unexpected Photochemistry Observed in a Lyophilized Productâ, oral presentation at the Annual Meeting of the American Society for Photobiology, Burlingame, CA, June 2008.
- Â Baertschi, S.W.*, Draper, J.R., Jansen, P.J., and Smith, William, K. âOxidative Susceptibility Testing: Rapid, Comprehensive, Screening Techniquesâ, invited oral presentation, 2nd Annual Conference on Forced Degradation, Informa Health Sciences, Amsterdam, Netherlands, Jan 31, 2008.
- Â Baertschi, S.W.*, and Alsante, K.M.* âFundamentals of Photochemistry and Photostability Testingâ, Organic Master Class, 2nd Annual Conference on Forced Degradation, Informa Health Sciences, Amsterdam, Netherlands, Jan 31, 2008.
- Â Â Baertschi, S.W.*, and Alsante, K.M.* âThe Chemistry of Drug Degradationâ, 1-Day Organic Master Class, 2nd Annual Conference on Forced Degradation, Informa Health Sciences, Amsterdam, Netherlands, Jan 31, 2008.
- Â Baertschi, S.W.*, Campbell, B.M., Draper, J.R., and Jansen, P.J. âAutomating the Analytical Laboratory: Is it Worth the Effort?â, invited oral presentation at the 4th Annual Forced Degradation conference, hosted by the International Institute for Research, Las Vegas, NV, Jan 22-24, 2007.
- Â Toltl, N, Baertschi, SW, Wozniak TJ, and Olsen, BA,* âArtifact Peaks in HPLC Impurity Analysis Caused by Trace Levels of Copperâ, poster presentation at HPLC, San Francisco, CA, 2006.
- Â Baertschi, S.W.* âDestroying Drugs for the Purpose of Bringing Them to Market: Pharmaceutical Stress Testingâ, invited oral presentations at the University of Wisconsin- Madison and UW-Milwaukee, Sept. 28-29, 2006.
- Â Baertschi, S.W., Campbell, B.M., Draper, J.R., and Jansen, P.J., âImplementing Automation in the Pharmaceutical Development Laboratory: The Symyx Automated Forced Degradation System,â Invited oral presentation at the Symyx User Group Meeting, Annapolis, MD, June 2006.
- Â Baertschi, S.W.*, Draper, J.R., Jansen, P.J., and Smith, W.K., âOxidative Susceptibility Testing: Rapid, Comprehensive Screening Techniquesâ, Invited oral presentation at the 3rd Annual Forced Degradation conference, Institute for International Research, Short Hills, NJ, Feb. 2006.
- Â Baertschi, S.W.* âDestroying Drugs for the Purpose of Bringing Them to Market: Pharmaceutical Stress Testingâ, invited oral presentation at the University of Oslo, Depts of Pharmaceutics and Chemistry, Oslo, Norway, November 2005.
- Â Baertschi, S.W.* âDestroying Drugs for the Purpose of Bringing Them to Market: Pharmaceutical Stress Testingâ, Short Course at Lehigh University, Bethlehem, PA, April 10, 2005.
- Baertschi, S.W.* âForced Degradation and Its Relationship to Real Time Drug Product Stabilityâ, APQ Open Forum, AAPS Annual Meeting, Nashville, TN, Nov 2005.
- Â Baertschi, S.W.,* Campbell, B.M., Draper, J.R., Jansen, P.J., Maxwell, L.N., and Smith, W.K âUncovering New Impurities by Investigating Mass Balance Issues Observed During Stress Testing Studiesâ, invited oral presentation, 5th Annual Impurities Summit, Institute for International Research, Princeton, NJ, May 18, 2005.
- Â Baertschi, S.W.,* Campbell, B.M., Draper, J.R., Jansen, P.J., Maxwell, L.N., and Smith, W.K â. âStrategies for Assessing Mass Balance in Partially-Degraded Samplesâ, invited oral presentation â3rd Annual Forced Degradation Conference: Best Practices for the Pharmaceutical Industry, Institute for International Research, Washington, DC, Feb. 15, 2004.
- Â Baertschi, S.W.,* and Alsante, K.M.* âThe Chemistry of Drug Degradationâ, oral presentation at the AAPS Sunrise School, AAPS National Meeting, Baltimore, MD, November 9, 2004.
- Â Baertschi, S.W.,* Draper, J.R., Jansen, P.J., Maxwell, L.N., and Smith, W.K. âOxidative Susceptibility Testing: Rapid, Comprehensive Screening Techniquesâ, Oxidative Degradation and Stabilization Conference, Institute for International Research, Princeton, NJ, July 20-21, 2004.
- Â Baertschi, S.W.* âStrategies for Investigation and Control of Degradation-Related Impuritiesâ, invited presentation at the FDA Impurities Workshop, Gaithersburg, MD, March 22 (2004).
- Â Baertschi, S.W.* âPharmaceutical Photostability: Sample Presentationâ, invited presentation as part of the short course on Pharmaceutical Photostability, Photostability 04: 5th International Conference on the Photostability of Drug Substances and Drug Products, London, UK, July 14-16 (2004).
- Â Baertschi, S.W.,* Jansen, P.J., Maxwell, L.N., and Smith, W.K. âStrategies for Investigation and Control of Degradation-Related Impuritiesâ, invited oral presentation, ACS Central Eastern Regional Meeting, Indianapolis, IN, June 2-4 (2004).
- Â Baertschi, S.W.* and K.M. Alsante,* âThe Chemistry of Drug Degradationâ, oral presentation, Forced Degradation: Best Practices for the Pharmaceutical Industry, Institute for International Research, Princeton, NJ, Feb. 24-25 (2004).
- Â Baertschi, S.W.,*, Nussbaum, M.A., Smith, W.K., and Jansen, P.J. âStrategies for Assessing Mass Balance in Partially-Degraded Samplesâ, invited oral presentation, AAI Stability Seminar, Wilmington, NC, March 26-27, 2003.
- Â Baertschi, S.W.,* Nussbaum, M.A., Smith, W.K., and Jansen, P.J., âStrategies for Assessing Mass Balance in Partially-Degraded Samplesâ, invited oral presentation, Detecting, Identifying, and Quantitating Impurities, Institute for International Research, Princeton, NJ, May 20-21, 2002.
- Baertschi, S.W.* âDestroying Drugs for the Purpose of Bringing Them to Market: Pharmaceutical Stress Testingâ, invited oral presentation at the Thomas L. Harris Symposium, Departments of Chemistry and the Center for Molecular Toxicology, Vanderbilt University, Nashville, TN, Sept 7, 2001.
- Baertschi, S.W.,* âICH Option 1 and Option 2 Sources: Potential for Different Photodegradation Pathwaysâ, oral presentation, Photostability 01: 4th International Conference on the Photostability of Drug Substances and Drug Products, Â Research Triangle Park, NC, July 16-19 (2001).
- Baertschi, S.W.*, âPharmaceutical photostability testing: sample presentationâ, invited oral presentation, Photostability 01: 4th International Conference on the Photostability of Drug Substances and Drug Products, Â Research Triangle Park, NC, July 16-19, 2001.
- Baertschi, S.W.*, âStrategies for Investigation and Control of Process-Related Impuritiesâ, invited oral presentation, Detecting, Identifying, and Quantitating Impurities, Institute for International Research, Philadelphia, PA, March 27-28, 2001.
- Baertschi, S.W.*, âCurrent Trends in Photostability 1 â Â Practical Considerations in Designing and Implementing Photostability Studiesâ, invited oral presentation, Stability of Pharmaceuticals: Current Issues, Practices, and Technologies, University of Wisconsin-Madison Seminar Series, Costa Mesa , CA, November 13-14, 2000.
- Allen, J.M.,* Allen S.A., Dreiman, J., and Baertschi, S.W. â2-Nitrobenzaldehyde: A Convenient UV-A and UV-B Chemical Actinometer for Drug Photostability Testingâ, oral presentation at â Photostability â99, joint meeting with 27th Annual Meeting of the American Society for Photobiology, Washington, DC, July 10-15, 1999.
- Baertschi, S.W., Kinney H.D., Snider, B.G.* âIssues in Evaluating the âIn-Useâ Photostability of Transdermal Patchesâ, oral presentation, Photostability â99, joint meeting with 27th Annual Meeting of the American Society for Photobiology, Washington, DC, July 10-15, 1999.
- Baertschi, S.W.* Â âDesigning and Implementing Photostability Studies in Alignment with ICH Guidelinesâ, invited oral presentation, Statistical Methods for Determining and Justifying Your Specifications and Shelf-Lifeâ, Institute for International Research, Bethesda, MD, Sept. 22-24, 1999.
- Baertschi, S.W.* Â âPractical Aspects of Pharmaceutical Photostability Testingâ, Photostability â99, invited oral presentation, joint meeting with 27th Annual Meeting of the American Society for Photobiology, Washington, DC, July 10-15, 1999.
- Baertschi, S.W.* Â âDesigning and Implementing ICH-Compliant Photostability Studiesâ, invited oral presentation, Pharmaceutical Stability: Statistical Applications, Regulatory Updates, and Current Industry Practicesâ, AAI Seminar Series, East Brunswick, NJ, February 22-23, 1999.
- Baertschi, S.W.* Â âDesigning and Implementing Photostability Studies in Alignment with ICH Guidelinesâ, invited oral presentation, Preparing for Changing Paradigms in Pharmaceutical Stability Programs, Institute for International Research, Philadelphia, PA, September 16, 1998.
- Baertschi, S.W.* Â âDesigning and Implementing Photostability Studies in Alignment with ICH Guidelinesâ, invited oral presentation, Barnett-Parexelâs Conference on Stability Testing, Washington, DC, September 14, 1998.
- Baertschi, S.W.* Â âPharmaceutical Stress Testingâ, invited oral presentation at Indiana State University-Terre Haute, Terre Haute, IN, March 17, 1998.
- Baertschi, S.W.* Â âDestroying Drugs for the Purpose of Bringing Them to Marketâ, invited oral presentation at Rocky Mountain College, Billings, MT, Feb. 26, 1998.
- Â Eckstein, M.,* Baertschi, S., Jansen, P., Maple, S., and Wozniak T., âA light-catalyzed formation of formaldehyde in a drug productâ, AAPS Meeting, Boston, MA, Nov. 2, 1997.
- Â Baertschi, S.W.* Â âPhotostability Testing: Â Practical Issues Related to Sample Exposureâ, invited oral presentation, Photostability, a 1997 Update; Scientific, Regulatory, and Practical Issues, AAI Seminar Series, Arlington, VA, February 24-25, 1997.
- Â Baertschi, S.W.* Â âThe Role of Stress Testing in Method Development and Validationâ, invited oral presentation, 1996 Calibration and Validation Symposium, Etobicoke, Ontario, October 2, 1996.
- Â Baertschi, S.W.* Â âThe Role of Stress Testing in Pharmaceutical Product Developmentâ, invited lecture, AAPS Midwest Regional Meeting, Chicago, IL, May 20, 1996.
- Â Â Â Baertschi, S.W.* âDestroying Drugs for the Purpose of Bringing Them to Market: Â Pharmaceutical Stress Testingâ, invited lecture, Indiana University-Purdue University at Indianapolis (IUPUI), February 21, 1996.
- Baertschi, S.W.,* Dorman, D.E., Occolowitz, J.L., Collins, M.W., and Lorenz, L.J. “Characterizing Drug Degradation Pathways Through Stress Testing: The Complex Degradation Chemistry of Cefaclor”, presented at the American Association of Pharmaceutical Sciences (AAPS) Meeting, Orlando, FL, Nov., 1993.
- Olsen, B.A.,* Baertschi, S.W., and Riggin, R.M. Â “Multidimensional Evaluation of Impurity Profiles for Generic Cephalexin and Cefaclor Antibiotics”, presented at the American Chemical Society National Meeting in Washington, D.C., August, 1992.
- Â Â Â Gopalakrishnan, S.,* Baertschi, S.W., Raney, K.D., Stone, M.P., and Harris, T.M. “Characterization of Aflatoxin B1-Oligonucleotide Adducts”, Sixth Conversation in Biomolecular Stereodynamics, State University of New York at Albany, 1989, 6.
- Â Â Â Brash, A.R.,* Baertschi, S.W., and Harris, T.M. “Non-cyclooxygenase Prostaglandin Biosynthesis: Â Formation of PGA3 Isomers via an Allene Oxide”, Biological Oxidation Systems [Proc. Symp.] 2, pp. 683-693 (1990)
- Â Â Â Stone, M.P.,* Harris, T.M., Baertschi, S.W., Byrd, S., Gopalakrishnan, S., and Raney K.D. Â “Equilibrium and Covalent Binding of Aflatoxins with DNA”, Biophysical Journal, 33rd annual meeting, 1989, 55, 240a.
- Â Â Â Harris, T.M.,* Baertschi, S.W., Raney, K.D., Gopalakrishnan, S., Byrd, S., and Stone, M.P. Â “Preparation and Reactions of Aflatoxin B1-Epoxide; the Ultimate Carcinogen of Aflatoxin B1”, Abstracts of the 40th American Chemical Society Southeast Regional Meeting, Atlanta, GA, November, 1988.
- Â Â Â Baertschi, S.W.,* Harris, T.M., Seibert, K., Wendelborn, D.F., and Roberts, L.J. II Â “Structure Elucidation of Prostaglandin F2 Isomers Arising by In Vitro Reduction of Prostaglandin D2 “, presented at the Southeastern Conference on Magnetic Resonance, 1986, Nashville, TN.
- Â Â Â Baertschi, S.W.,* Harris, T.M., and Brash, A.R. Â “Determination of the Relative Stereochemistry of the Alkyl Side-Chains of Prostanoid Compounds by 1H-NMR”, presented at the Southeastern Conference on Magnetic Resonance, 1986, Nashville, TN.
*Presenter(s)
NON-PEER REVIEWED MANUSCRIPTS
- Choudhury DR, Sood RK, Bobiak J, Alasandro M, Baertschi SW, Komas Bekki, Skibic MJ, Pack BW, Thomas S, Seevers RH, Huynh-ba K, and Colgan S. âPharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and Commercializationâ, Pharmaceutical Technology, Oct (2012)
- Alsante KM,* Martin, L., and Baertschi, SW* âA Stress Testing Benchmarking Studyâ, Pharmaceutical Technology, 27:2, pp. 60-72, February (2003).
*Corresponding author(s)
UNREFEREED PUBLICATIONS
- Stability Testing Requirements Proliferate Globally While Manufacturers Develop Better, Faster Methods, The Gold Sheet, March 1, 2011 and PharmAsia News, April 4, 2011. (article by Joanne S. Eglovich)
- Drug Manufacturers Endorse QbD Model for Drug Stability Submittals, The Gold Sheet. Â Oct 11, (2007). (article by Joanne S. Eglovich)
- Baertschi, S.W.*, Jansen, P.J., and Ausman, D.  âLilly Automation Takes the Stress out of Stress Testingâ, Molecular Connection, Symyx newsletter, Fall issue (2008).
- Baertschi, S.W.,*Â and Alsante, K.M.* âDraft Concept Paper for Initiating Revision Process for ICH Q1B â Guideline for the Photostability Testing of New Drug Substances and Productsâ, presented to Robert Baum, Pfizer, the industry representative to ICH for the photostability guideline for review by the Expert Working group, February (2003).
- Dorman, D.E.* and Baertschi, S.W. âDegradation of Cefaclorâ, Texas A&M Newsletter, âNoteâ (1991).
*Corresponding author(s)
BOOK CHAPTERS
- Baertschi SW, Teasdale A, âAddressing the complex problem of degradation- derived mutagenic impurities in drug substances and productsâ, in MutagenicÂ
- Impurities: Strategies for Identification and Control, 2nd Edition, Teasdale A, Editon, Wiley, New Jersey, USA (2020).Â
- Baertschi SW*, Olsen BA, âMutagenic Impuritiesâ, in Specification of Drug Substances and Drug Products: Development and Validation of Analytical Methods, Second Edition, Riley CM, Rosanske TW, Reid GL, Editors, Elsevier, New York Second Edition, Riley CM, Rosanske TW, Reid GL, Editors, Elsevier, New York (2019).Â
- Baertschi SW, Hetrick EM, Hoaglund Hyzer CS, Pack BW, Roberts JC, and Wolfe CN, âImplementing an Accelerated Stability Assessment Programâ, Chapter 11 in Predictive Accelerated Predictive Stability: Fundamentals and Pharmaceutical Industry Practices, Qiu F and Scrivens G, Editors, Elsevier (2018) https://doi.org/10.1016/B978-0-12-802786-8.00011-5.
- United States Pharmacopeia Impurities Expert Panel (Member, Baertschi SW et al.), âImpurities in Drug Substances and Drug Productsâ, USP General Chapter <1086>, Dec 2013.
-  United States Pharmacopeia Impurities Expert Panel (Member, Baertschi SW et al.), âOrganic Impurities in Drug Substances and Drug Productsâ, USP Mandatory Chapter <476>, Dec 2013.
-  Tønnesen HH, and Baertschi SW, âPhotoreactivity of drugs in vitro and in vivoâ, book chapter published online at http://www.photobiology.info/ (2010).
- Co-authored eight chapters in Pharmaceutical Stress Testing: Predicting Drug Degradation, 2nd Edition, S.W. Baertschi, K.M. Alsante, and R.A. Reed, Editors, Informa Healthcare, London, UK (2011).
- Degradants Alsante, K.M., Baertschi, S.W., Coutant, M. Marquez, B.L., Sharp, T.R., and Zelesky, T.C., âDegradation and Impurity Analysis for Pharmaceutical Drug Candidatesâ, in Separation Science and Technology (San Diego, CA, USA), Handbook of Modern Pharmaceutical Analysis, 2nd Edition, Ahuja, S., and Scypinski, S., Editors, Elsevier, 59-169 (2010).
- Â Baertschi, S.W., âForced Degradation and Its Relationship to Real Time Drug Product Stabilityâ, Proceedings from the AAPS Stability Workshop held in September 2007, Bethesda, MD, Huynh-Ba, K., Editor, Springer Publishing, New York (2009).
- Co-authored seven chapters in Pharmaceutical Stress Testing: Predicting Drug Degradation, S.W. Baertschi, Editor, Taylor & Francis, New York (2005). 7  Introduction
-  Tønnesen, H.H.,* and Baertschi, S.W. âPhotostability testing:  the questions most frequently askedâ, in Photostability of Drugs and Drug Formulations, 2nd edition, Tonnesen, H.H., Ed., CRC Press, Boca Raton, FL (2004).
-  Olsen, B.A.,* and Baertschi, S.W.* âStrategies for investigation and control of process-related and degradation-related impurities in pharmaceuticalsâ, in Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, Ahuja, S., and Alsante, K.M., Eds., volume 5 of âSeparation Science and Technologyâ, Academic Press, (2003).
-  Baertschi, S.W.*, and Thatcher, S.R. âSample presentation for photostability studies: problems and solutionsâ, in Pharmaceutical Photostability and Stabilization Technology, Piechocki, J., Editor, Taylor & Francis, New York, (2006).
-  Harris, T.M.,* Gopalakrishnan, S., Baertschi, S.W., Raney, K.D., Raney, V.M., Byrd, S., and Stone, M.P.  âSynthesis and Characterization of Aflatoxin B1 Epoxide and Its Adducts with Oligodeoxynucleotidesâ in Mycotoxins, Cancer, and Health, vol. 1, Pennington Center Nutrition Series, (Bray. G.A., and Ryan, D.H., Eds.), pp. 142-152, Louisiana State University Press, Baton Rouge (1991).
-  Guengerich, F.P.,* Shimada, T., Raney, K.D., Kim, D.-H., Baertschi, S.W., and Harris, T.M.  âBioactivation of Aflatoxins and Sterigmatocystin by Human Liver Cytochrome P-450 Enzymesâ in Mycotoxins, Cancer, and Health, vol. 1, Pennington Center Nutrition Series, (Bray. G.A., and Ryan, D.H., Eds.), pp. 153-163, Louisiana State University Press, Baton Rouge (1991).
-  Brash, A.R.,* Baertschi, S.W., Ingram, C.D., and Harris. T.M. âAllene Oxides as Intermediates in Biosynthesis of Ketols and Cyclopentenonesâ  Adv. Prostaglandin, Thromboxane, Leukotriene Res. (Samuelsson, B., Wong, Y.-K., and Sun, F.F., Eds.), 19, Raven Press, New York, pp.70-73 (1988).
EDITOR ROLES
-  Journal: Trends in Analytical Chemistry, Special Issue on Drug Stability, Baertschi SW and Gorog S, Editors, Sept (2013).
-  Book:  Pharmaceutical Stress Testing: Predicting Drug Degradation, Drugs in the Pharmaceutical Sciences, 2nd Edition, S.W. Baertschi,, Karen M. Alsante, and R.A. Reed, Editors, Informa Healthcare, New York, July, (2011).  (More than 680 copies sold as of Sept 2012)
-  Book: Pharmaceutical Stress Testing: Predicting Drug Degradation, Drugs in the Pharmaceutical Sciences, vol 153, S.W. Baertschi, Editor, Taylor & Francis, New York (2005).  (More than 2300 copies sold as of July 2011)