REFEREED / PEER REVIEWED
  1. Hoaglund Hyzer C,* Williamson ML, Jansen PJ, Montgomery RM, Kopach ME, Scherer RB, and Baertschi SW, “Mechanistic Studies of the N-Formylation of Edivoxetine, a Secondary Amine-Containing Drug, in a Solid Oral Dosage Form”, J. Pharm. Sci., DOI: 10.1016/j.xphs.2017.01.026.
  2. Jansen PJ,* Smith WK, Dorman DE, Kemp CAJ, McCune KA, Baertschi SW,* “Determination of the Degradation Chemistry of the Anti-Tumor Agent Pemetrexed Disodium”, J. Pharm. Sci., 105:11, 3256-3268 (2016). http://dx.doi.org/10.1016/j.xphs.2016.06.029
  3. Baertschi SW,* Olsen BA, Wozniak TJ, Toltl N, O’Shea C, Jansen PJ, “Formation of copper (I) from trace levels of copper (II) as an artifactual impurity in the HPLC analysis of olanzapine”, J. Pharm. Biomed. Anal., DOI:10.1016/j.jpba.2016.03.040.
  4. Allain L, Baertschi SW, Clapham D,* Foti C, Lantaff WM, Reed RA, Templeton AC,* and Tonnesen, HH, “Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products Part 3. Oral Drug Products”, J. Pharm. Sci., DOI: 10.1002/jps.24396.
  5. Zhang T, and Baertschi SW, “Why Should We Care About Publishing?”, Org. Proc. Res. Dev. 2015, 19, 559−560.
  6. 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.
  7. Strege M, Osborne L, Hetrick E, Dill, A, Jansen PJ, Draper JR, Montgomery RM, Buser J, Smitka T, Pack B, Baertschi SW, “Assessing the Risk of Formation of Potential Genotoxic Degradation Products in a Small-Molecule Kinase Inhibitor Drug Substance and Drug Product”, Org. Proc. Res. Dev., 19:11, 1458-1464 (2015), DOI: 10.1021/acs.oprd.5b00112.
  8. Nefliu M,* Foti C,* Zelesky T, Sluggett G, Jansen PJ, Baertschi SW, and Harmon PA, “Artifacts Generated During Azoalkane Peroxy Radical Oxidative Stress Testing of Pharmaceuticals Containing Primary and Secondary Amines”, J. Pharm. Sci., 104: 12, 4287-4298 (2015). Nov 13: 10.1002/jps.24667.
  9. 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.
  10. Strege M, Osborne L, Hetrick E, Dill, A, Jansen PJ, Draper JR, Montgomery RM, Buser J, Smitka T, Pack B, Baertschi SW, “Assessing the Risk of Formation of Potential Genotoxic Degradation Products in a Small-Molecule Kinase Inhibitor Drug Substance and Drug Product”, Org. Proc. Res. Dev., DOI: 10.1021/acs.oprd.5b00112.
  11. 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).
  12. 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).
  13.  Kleinman MH,* Baertschi SW, Alsante KM, Reid DL, Mowery MD, Shimanovich R, Foti C, Smith WK, Reynolds DW, Nefliu M, and Ott MA. “In Silico Prediction  of Pharmaceutical Degradation Pathways: A Benchmarking Study”, Mol. Pharm,11, 4179-4188 (2014).
  14.  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., “Recent 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 Landscape”, AAPS PharmSciTech, 15:1, (2014) 237-251.
  15.  Gorog, S., and Baertschi, SW, “The Role of Analytical Chemistry in Drug-Stability Studies”, Trends in Analytical Chemistry, 49, 55-56 (2013).
  16.  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, “Recent 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 “, AAPS PharmSciTech, 15(1), 198-212 (2013).
  17.  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, “Investigation of the Mechanism of Racemization of Litronesib in Aqueous Solution: Unexpected Base-Catalyzed Inversion of a Fully-Substituted Carbon Chiral Center”, J.Pharm.Sci, 103:2797–2808 (2014).
  18.  Myers DP*, Hetrick EM, Zhongming L, Hadden CE, Bandy S, Kemp CAJ, Harris TM, Baertschi SW, “On-Column Nitrosation of Amines Observed in HPLC Impurity Separations Employing Ammonium Hydroxide and Acetonitrile as Mobile Phase”, J. Chrom. A., 1319, 57-64 (2013).
  19.  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).
  20.  Baertschi SW,* Pack BW, Hoaglund-Hyzer CS, and Nussbaum MA, “Assessing Mass Balance in Pharmaceutical Drug Products: New Insights into an Old Topic”, Trends in Analytical Chemistry, 49, 126-136 (2013).
  21.  Dow LK,* Pack BW, Hansen MM, and Baertschi SW, “The Assessment of Impurities for Genotoxic Potential and Subsequent Control in Drug Substance and Drug Product”, J. Pharm. Sci., Commentary, 102(4), 1404-1418 (2013).
  22.  Raillard SP, Bercu J, Baertschi SW, and Riley CM, “Prediction of Drug Degradation Pathways Leading to Structural Alerts for Potential Genotoxic Impurities”, Org. Proc. Res. and Dev., 14, 1015-1020 (2010).
  23.  Baertschi SW, Alsante KM, and Tønnesen HH, “A Critical Assessment of the ICH Guideline on Photostability Testing of New Drug Substances and Products (Q1B): Recommendation for Revision”, J. Pharm. Sci., 99:7, 2934-2940 (2010).
  24.  Skibic MJ, King LA, Khan M, Fox PJ, Winger BE, and Baertschi SW* “Artifactual Formylation of Duloxetine Hydrochloride by Acetonitrile in the Presence of Titanium Dioxide and Ultrasonication: Implications for HPLC Method Development”, J. Pharm. Biomed. Anal.,53, 432-439 (2010).
  25.  Baertschi SW,* Brunner H, Bunnell CA, Cooke GG, Diseroad B, Dorman DE, Jansen PJ, Kemp CAJ, Maple SR, McCune KA, and Speakman JL, “Isolation, Identification, and Synthesis of Two Degradation Products of Olanzapine (LY170053)”, J. Pharm. Sci., 97:2, 883-892 (2008).
  26.  Baertschi SW*, “Analytical Methodologies for Discovering and Profiling Degradation-Related Impurities”, Trends in Analytical Chemistry, 25:8, 758-767 (2006).
  27.  Nussbaum MA,* Baertschi SW, and Jansen PJ, “Determination of Relative UV Response Factors by use of a Chemiluminescent Nitrogen-Specific HPLC Detector”, J. Pharm. Biomed. Anal., 27, 983-993 (2002).
  28.  Thatcher SR,* Mansfield RK, Miller RB, Davis CW, and Baertschi SW,* “Pharmaceutical Photostability:  A Technical and Practical Interpretation of the ICH Guideline and Its Application to Pharmaceutical Stability: Part II”, Pharmaceutical Technology, 25:4, pp. 50-62, April (2001).
  29.  Thatcher SR,* Mansfield RK, Miller RB, Davis CW, and Baertschi SW,* “Pharmaceutical Photostability:  A Technical and Practical Interpretation of the ICH Guideline and Its Application to Pharmaceutical Stability: Part I”, Pharmaceutical Technology, 25:3, pp. 98-110, March (2001).
  30.  Baertschi SW,* Kinney H., and Snider BG., Issues in Evaluating the ‘In-Use’ Photostability of Transdermal Patches”, Pharmaceutical Technology, Sept. 70-80 (2000).
  31.  Allen JM,* Allen SK, and Baertschi SW, “2-Nitrobenzaldehyde: A Convenient UV-A and UV-B Chemical Actinometer for Drug Photostability Testing”, J. Pharm. Biomed. Anal., 24, 167-178 (2000).
  32.  Jansen PJ,* Akers MJ, Amos RM, Baertschi SW, Cooke GG, Dorman DE, Kemp CAJ, Maple SR, and McCune KA. “The Degradation of the Anti-Tumor Agent Gemcitabine Hydrochloride in an Acidic Aqueous Solution and Identification of the Degradation Products”, J. Pharm. Sci.89:7, 885-891 (2000).
  33.  Hartauer K.,* Arbuthnot G., Baertschi SW, Johnson R, Luke W, Pearson N, Rickard E, Tsang P, and Wiens R. “Influence of Peroxide Impurities in Povidone and Crospovidone on the Tablet Stability of Raloxifene Hydrochloride. Identification and Control of an Oxidative Degradation Product”, Pharmaceutical Development and Technology5:3, 303-319 (2000).
  34.  Wirth DD,* Baertschi SW, Johnson RA, Maple SR, Miller MS, Hallenbeck DK, and Gregg SM, “Maillard Reaction of Lactose and Fluoxetine Hydrochloride, a Secondary Amine”, J. Pharm. Sci.87:1, 31-39 (1998).
  35. Jansen PJ*, Oren PL, Kemp CAJ, Maple SR, and Baertschi SW*, “Characterization of Impurities Formed by Interaction of Duloxetine HCl with Enteric Polymers Hydroxypropyl Methylcellulose Acetate Succinate (HPMCAS) and Hydroxypropyl Methylcellulose Phthalate (HPMCP)”, J. Pharm. Sci.87:1, 81-85 (1998).
  36.  Baertschi SW* “Commentary on the Quinine Actinometry System Described in the ICH Draft Guideline on Photostability Testing of New Drug Substances and Products” Drug Stability1:4, 193-195 (1997).
  37. Dorman DE,* Lorenz LJ, Occolowitz JL, Spangle LA, Collins MW, Bashore, FN, and Baertschi, SW.  “Isolation and Structure Elucidation of the Major Degradation Products of Cefaclor in the Solid State”, J. Pharm. Sci.86:5, 540-549 (1997).
  38. Baertschi SW,* Dorman DE, Occolowitz JL, Spangle LA, Collins MW, Bashore FN, and Lorenz LJ.  “Isolation and Characterization of the Major Degradation Products Arising from Aqueous Degradation of Cefaclor”, J. Pharm. Sci.86:5, 526-539 (1997).
  39.  Baertschi SW,* Boyd DB, Cantrell AS, Jaskunas SR, Kuhfeld MT, and Lorenz LJ. “Inhibition of HIV-1 Reverse Transcriptase by Degradation Products of Ceftazidime” Antiviral Chemistry and Chemotherapy8:4, 353-362 (1997).
  40. Baertschi SW,* Dorman DE, Spangle LA, Lorenz LJ, Collins MW, and Occolowitz JL. “Formation of Fluorescent Pyrazine Derivatives via a Novel Degradation Pathway of the Carbacephalosporin Loracarbef”, J. Pharm. Biomed. Anal.13:3, 323-328 (1995).
  41.  Olsen BA,* Baertschi SW, and Riggin RM.  “Multidimensional evaluation of impurity profiles for generic cephalexin and cefaclor antibiotics”, J. Chromatography648, 165-173 (1993).
  42. Skibic M, Taylor KW, Occolowitz JL, Collins MW, Paschal J, Lorenz LJ, Spangle LA, Dorman DE, and Baertschi SW.* “Aqueous Acidic Degradation of the Carbacephalosporin Loracarbef”, J. Pharm. Sci.82:10, 1010-1017 (1993).
  43.  Baertschi SW,* Dorman DE, Occolowitz JL, Spangle LA, Collins MW, and Lorenz LJ. “Isolation and Structure Elucidation of a Novel Product of the Acidic Degradation of Cefaclor”, J. Pharm. Sci.82, 622-626 (1993).
  44.  Song W.-C., Baertschi SW, Boeglin, WE, Harris TM, and Brash AR.*  “Formation of Epoxyalcohols by a Purified Allene Oxide Synthase: Implications for the Mechanism of Allene Oxide Synthesis”, J. Biol. Chem. 268, 6293-6298 (1993).
  45.  Brash AR,* Baertschi SW, and Harris TM.  “Formation of Prostaglandin A Analogues Via an Allene Oxide”, J. Biol. Chem.265, 6705-6712 (1990).
  46. Harris TM,* Stone MP, Gopalakrishnan S., Baertschi SW., Raney KD, and Byrd S. “Aflatoxin B1 Epoxide, the Ultimate Carcinogenic Form of Aflatoxin B1: Synthesis and Reaction with DNA” J. Toxicol.-Toxin Reviews 8 (1&2), 111-120 (1989).
  47.    Atsmon J, Sweetman BJ, Baertschi SW, Harris TM, and Roberts L.J. II* “Formation of Thiol Conjugates of 9-Deoxy-D9,D12(E)-prostaglandin D2 and D12(E)-Prostaglandin D2″, Biochemistry 29, 3760-3765 (1990).
  48. Baertschi SW. Ph.D. “Chemical and Biological Studies of Aflatoxins and Prostanoids”, Ph.D. Thesis, Avail. Univ. Microfilms Int., Order No. DA9006837, 178 pp. (1989)
  49. Baertschi SW,* Brash AR, Harris TM.  “Formation of a Cyclopropyl Eicosanoid via an Allene Oxide in the coral Plexaura homomalla:  Implications for the Biosynthesis of 5,6-trans-PGA2″ J. Am. Chem. Soc., 111, 5003-5005 (1989).
  50.    Baertschi SW, Raney KD, Shimada T, Harris TM, and Guengerich FP*  “Comparison 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 Responses” Chem. Res. Toxicol., 2, 114-122 (1989).
  51.    Baertschi SW,* Raney KD, Stone MP, and Harris TM.  “Preparation of the 8,9-epoxide of the Mycotoxin Aflatoxin B1; the Ultimate Carcinogenic Species”  J. Am. Chem. Soc.110, 7929-7931 (1988).
  52.    Brash AR,* Baertschi SW, Ingram CD, and Harris TM. (1988) “Isolation and Characterization of Natural Allene Oxides: Unstable Intermediates in the Metabolism of Lipid Hydroperoxides”  Proc. Natl. Acad. Sci. USA85, 3382-3386 (1988).
  53.    Baertschi SW, Ingram CD, Harris TM, and Brash AR.* (1988) “Absolute Configuration of cis-12-Oxophytodienoic Acid of Flaxseed:  Implications for the Mechanism of Biosynthesis from the 13(S)-Hydroperoxide of Linolenic Acid”  Biochemistry27, 18-24 (1988).
  54.    Brash AR,* Baertschi SW, Ingram CD, and Harris TM. (1987) “On 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 Prostanoid”  J. Biol. Chem.262, 15829-15839 (1987).
  55. Neflui M,* Foti C,* Zelesky T, Sluggett G, Jansen PJ, Baertschi SW, and Harmon PA, “Artifacts Generated During Azoalkane Peroxy Radical Oxidative Stress Testing of Pharmaceuticals Containing Primary and Secondary Amines”, J. Pharm. Sci., in press.

*Corresponding author(s)

POSTERS, ORAL PRESENTATIONS, AND PUBLISHED ABSTRACTS
  1. Baertschi SW, “Predictability of Forced Degradation Studies for Real World Stability”, presented at Sindusfarma workshop on Degradation Products and Qualification, Sao Paulo, Brazil, Oct 24-25 (2016).
  2. Baertschi SW, “Drug Degradation Mechanisms: Why Are They Important”, Science of Stability conference, Newark, NJ, Sept 25-27, 2016.
  3. Baertschi SW, “Predicting, Assessing, and Controlling Mutagenic Impurities
    from Degradation”, Land O’Lakes Conference on Pharmaceutical Analysis, Madison, WI, Aug 1-4, 2016.
  4. Baertschi SW, “Assessing the Impact of Mutagenic Impurities Regulations”, Waters/ CERSI Conference on Ensuring Drug Quality, Baltimore, MD, May 18-19, 2016.
  5. Baertschi, SW, DeAntonis D, Mowery M, and Scott B, “ICH M7 and Mutagenic Impurities”, AAPS Joint Focus Group Face-to-Face Meeting, Gaithersburg, MD, April 6 (2016).
  6. Baertschi SW, “Mutagenic Degradation Products:  Theoretical and [Semi]Empirical Approaches for Predicting, Discovering, and Controlling”, AAPS Stability Workshop, USP Headquarters, Rockville, MD April 4-5, 2016,
  7. Baertschi SW, “Mutagenic Degradation Products: Risk Assessment and Control”, AAPS Workshop on Mutagenic Impurities, AAPS Annual Meeting, Orlando, FL, Oct 25, 2015.
  8. Dill AL, Baertschi SW, Kramer T, and Sperry DC, “Predicting the Degradation Rate as a Function of Drug Load in Solid-State Drug Products”, Science of Stability Conference, Mashantucket, CT, Oct 12-14, 2015.
  9. Baertschi SW, “Fundamental of Predicting Oxidative Degradation Products”, Science of Stability Conference, Mashantucket, CT, Oct 12-14, 2015.
  10. Baertschi SW, “In Silico Prediction of Degradation Chemistry”, Science of Stability Conference, Mashantucket, CT, Oct 12-14, 2015.
  11. Baertschi SW, “In-Use Photostability: Injectables”, Photostability 2015, Academy of Pharmaceutical Sciences of Great Britain, Loughborough, UK Oct 5, 2015.
  12. Baertschi SW, “Unexpected Photoinstability: Compounds With No Apparent Absorption of Light!?”, Photostability 2015, Academy of Pharmaceutical Sciences of Great Britain, Loughborough, UK Oct 5, 2015.
  13. Baertschi SW, “Fundamentals of Photochemistry and Photostability Testing”, Photostability 2015, Academy of Pharmaceutical Sciences of Great Britain, Loughborough, UK Oct 5, 2015.
  14. Baertschi SW, “Predictablity of Forced Degradation Studies for Real World Stability”, presented at ANVISA reviewer training workshop on “Forced Degradation”, Brasilia, Brazil, Oct 22 (2014).
  15.  Baertschi SW, “Predictablity of Forced Degradation Studies for Real World Stability”, presented at Sindusfarma workshop on “Forced Degradation”, Sao Paulo, Brazil, Oct 20-21 (2014).
  16.  Baertschi SW, “Overview of Pharmaceutical Photostability Testing”, presented at Sindusfarma workshop on “Forced Degradation”, Sao Paulo, Brazil, Oct 20-21 (2014).
  17.  Baertschi SW, “Fundamentals of Predicting Oxidative Impurities”, presented at Sindusfarma workshop on “Forced Degradation”, Sao Paulo, Brazil, Oct 20-21 (2014).
  18.  Dill A, Baertschi SW,* Kramer T, and Sperry DC “Predicting the Degradation Rate as a Function of Drug Load in Solid-State Products”, presented at the SES Annual Technical Meeting, “Pharmaceutical Solids: Synthesis, Manufacturing, Characterization, and Modeling”, Purdue University, Oct 3 (2014).
  19.  Dill A,* Baertschi SW,* Kramer T, and Sperry DC “Predicting the Degradation Rate as a Function of Drug Load in Solid-State Products”, presented at the Conference on Small Molecule Science, Williamsburg, VA, Aug 10 (2014).
  20.  Baertschi SW,* “Lean Strategies for Conducting Forced Degradation Studies and Downstream Implications”, AAPS Symposium on Stability, AAPS Annual Meeting, Nov 14, San Antonio, TX (2013).
  21.   Baertschi SW,* “Unexpect Stability Issues Related to Unexpected Impurities from Excipients”, AAPS Atypical Impurities Workshop, Nov 9-10, San Antonio, TX (2013).
  22.  Baertschi SW,* “Lean Stability: Forced Degradation, Real Time Stability, and Analytical Methodology”, invited oral presentation at a workshop on Stability for ANVISA, ANVISA Headquarters, Brasilia, Brazil, Oct 2-3 (2013).
  23.  Baertschi SW,* “Overview of Pharmaceutical Photostability Testing”, invited oral presentation at a workshop on Stability for ANVISA, ANVISA Headquarters, Brasilia, Brazil, Oct 2-3 (2013).
  24.  Baertschi SW,* McFarland AD, Stephenson GA, “Physical Stability Issues in Pharmaceutical Development”, invited oral presentation at a workshop on Stability for ANVISA, ANVISA Headquarters, Brasilia, Brazil, Oct 2-3 (2013).
  25.   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).
  26.  Dow L,* Pack B, Baertschi SW, Hansen M, Page TJ, “The assessment of impurities for genotoxic potential and subsequent control in drug substance and drug product” – oral presentation at 5th Annual Genotoxic Impurities conference, Informa Life Sciences (Berlin), June (2013).
  27.  Kopach ME*, Baertschi SW, Kobierski ME, Nguyen Hawk MK,  Dione A,  Williamson ML, Hoaglund-Hyzer C, and Jansen PJ, “Understanding the pharmaceutically-relevant Maillard reaction”, invited presentation at Drug Discovery & World Congress, June 3 (2013).
  28.  Baertschi, S.W.* and Mowery, M. “ICH M7 Guidance on Genotoxic Impurities: Implications for the Analytical Laboratory”, invited oral presentation at the 52nd Annual Pharmaceutical Analysis /, Land O’Lakes Conference, Aug (2012).
  29.   Myers DP, Liang Z, Hetrick E, Hadden C, Bandy S, Harris TM, and Baertschi, SW,“On-column N-nitrosylation of amines observed in high pH HPLC impurity separations”, invited oral presentation at Eastern Analytical Symposium, Somerset, NJ, Nov 12-15 (2012).
  30.  Foti, C*; Alsante, K; Baertschi, S.W. “The Chemistry of Drug Degradation”, 1-day workshop, Eastern Analytical Symposium, Somerset, NJ, Nov 12-15 (2012).
  31.  Mowery, MA* and Baertschi, S.W. “Potential Genotoxic Degradants: ICH Working Group Update”, invited oral presentation at the AAPS Annual Meeting Preconference Workshop on Predicting and Monitoring Impurities in API and Drug Products, Oct 13-14, 2012.
  32.   Baertschi, S.W.*, Fundamentals of Predicting Oxidative Impurities”, invited oral presentation at the AAPS Annual Meeting Preconference Workshop on Predicting and Monitoring Impurities in API and Drug Products, Oct 13-14, 2012.
  33.   Baertschi, S.W.*, “Revisiting Old Concepts: New Insights into the Concept of Mass Balance in Drug Products”, invited oral presentation at the AAPS Annual Meeting Preconference Workshop on Predicting and Monitoring Impurities in API and Drug Products, Oct 13-14, 2012.
  34.  Kramer TT, Ritcher DW, Jansen PJ, Risley DS, Sharp V.S, and Baertschi SW*, “New Ways to Visualize the Results of Forced Degradation Studies”, invited oral presentation at Conference on Small Molecule Science, Providence, RI, Sept 10, 2012.
  35.  Alsante, K*, Baertschi, S.W., and Foti, C., “Reviewing Advances in Knowledge of Drug Degradation Chemistry”, Forced Degradation for Pharmaceuticals, Informa Life Sciences, London, UK, Jan 18-19, 2012.
  36.  Baertschi, S.W.,* Dow, L., Hansen, M., and Pack, B., “Stress Testing and Degradation-Derived Genotoxic Impurities:  Scientific, Practical, and Regulatory Considerations”, Challenges and Opportunities for the Control of Genotoxic Impurities Symposium, AAPS Annual Meeting, Washington, DC, Oct 26, 2011.
  37.  McFarland, A.D.,* Stephenson, G.A., and Baertschi, S.W.*, “Challenges in the Analytical Characterization of Physical Stability Issues”, Predicting and Managing Stability Programs with Physical Stability Issues Symposium, AAPS Annual Meeting, Washington, DC, Oct 26, 2011.
  38.  Skibic, M.J.*, King, L.A., Khan, M., Fox, P.J., Winger, B.E., and Baertschi, S.W., “Artifactual Formylation of the Secondary Amine of Duloxetine Hydrochloride by Acetonitrile in the Presence of Titanium Dioxide: Implications for HPLC Method Development”, AAPS Stability Workshop, Washington, DC, October 22-23, 2011.
  39.  Baertschi, S.W.*, Alsante, K.M., and Tonnesen, H.H., “ICH Q1B Photostability Guideline: Time for a Revision?”, AAPS Stability Workshop, Washington, DC, October 22-23, 2011.
  40.  Skibic, M.J.*, King, L.A., Khan, M., Fox, P.J., Winger, B.E., and Baertschi, S.W., “Artifactual Formylation of the Secondary Amine of Duloxetine Hydrochloride by Acetonitrile in the Presence of Titanium Dioxide: Implications for HPLC Method Development”, Conference on Small Molecule Science, UNC-Chapel Hill, Aug 2, 2011.
  41.  Jansen, P.J.*, Williamson, M., Hoaglund-Hyzer, C., Kopach, M., and Baertschi, S.W. “Drug-Excipient Compatibility: Investigation of the Mechanism of N-Formylation of Amines by Reducing Sugars”, Conference on Small Molecule Science, UNC-Chapel Hill, Aug 2, 2011.
  42.  Baertschi, S.W.*, Elder, D., Kleinman, M. McKeown, A., Mowery, M., Norwood, D., Teasdale, A., Dow, L., and Pack, B. “Stress Testing and Degradation-Derived Genotoxic Impurities: Scientific, Practical, and Regulatory Considerations”, Conference on Small Molecule Science, UNC-Chapel Hill, Aug 2, 2011.
  43.   Pack, B.W.,* Hetrick E., Dow L., Baertschi, S.W., Hansen, M. “Overcoming the hurdles to rapid and accurate prediction of shelf-life and degradation profiles”, invited oral presentation at “Impurities”, sponsored by Informa Life Sciences, Prague, Czech Republic, Sept. 15, 2011.
  44.  Baertschi, S.W.*, “Fundamentals of Photochemistry and Photostability Testing”, USP Workshop, Sao Paulo, Brazil, May 19-20, 2011.
  45.   Baertschi, S.W.*, “Strategies for Investigation and Control of Degradation-Related Impurities”, USP Workshop, Sao Paulo, Brazil, May 19-20, 2011.
  46.   Baertschi, S.W.*, Jansen, P.J., Campbell, B.M., and Draper, J.R. “Implementing Automation in the Pharmaceutical Development Laboratory: The Symyx Automated Forced Degradation System”, Symyx Global Symposium, Prague, Czech Republic, May 20, 2008.
  47.   Baertschi, S.W.,* “The Foundational Aspects of Predicting Drug Degradation”, invited oral presentation at the DIA / AAPS co-sponsored CMC Workshop: Translating Science into Successful Regulatory Submissions, Washington, DC, Feb 7-9, 2011.
  48.   Baertschi, S.W.*, and Jansen, Patrick J. “Degradation or Artifact: Stress Testing Brain Teasers”, invited oral presentation at the“5th Annual Conference on Forced Degradation”, Informa Life Sciences, London, UK, Jan 25-26, 2011.
  49.   Baertschi, S.W.*, “Stress Testing: Predictive or Overkill”, invited oral presentation at the“5th Annual Conference on Forced Degradation”, Informa Life Sciences, London, UK, Jan 25-26, 2011.
  50.  Baertschi, S.W.*, “Predicting Drug Degradation”, invited oral presentation at the AAPS Workshop on Stability Testing in Pharmaceutical Development, New Orleans, LA, November 14, 2010.
  51.  Baertschi, S.W.*, Raillard,S., Bercu, J., and Riley, C.M. “Prediction of Drug Degradation Pathways Leading to Structural Alerts for Potential Genotoxic Impurities”, invited oral presentation, Informa Life Sciences Conference on Genotoxic Impurities, June 29, Zurich, Switzerland, 2010.
  52.  Baertschi, S.W.* “Patterns and Pathways: Using Chemistry to Guide the Characterization of Drug Degradation Products”, invited oral presentation, 6th Annual Forced Degradation Forum, Institute for International Research, Philadelphia, PA, March 15-16, 2010.
  53.  Baertschi, S.W.* “Destroying Drugs for the Purpose of Bringing Them to Market”, and “Working as a Scientist in the Pharmaceutical Industry”, Vanderbilt University, Center in Molecular Toxicology Seminar Series, Nashville, TN, Feb 24, 2010.
  54.  Baertschi, S.W.* “Patterns and Pathways: Using Chemistry to Guide the Characterization of Drug Products”, invited oral presentation, Eastern Analytical Symposium, Somerset, NJ, November 18, 2009.
  55.  Alsante, K.M.*, and Baertschi, S.W.* “The Chemistry of Drug Degradation”, One Day Short Course, Eastern Analytical Symposium, Somerset, NJ, November 17, 2009.
  56.  Baertschi, S.W.*, invited oral presentation, “Predicting Drug Degradation via in cerebro Knowledge: A Fresh Look at Degradation Pathways”, AAPS Stability Workshop, National Harbor, MD, Sept 24-25, 2009.
  57.  Baertschi, S.W.*, Draper, J.R., Jansen, P.J., and Smith, William, K. “Oxidative Susceptibility Testing: Rapid, Comprehensive, Screening Techniques”, invited oral presentation, 3rd Annual Conference on Forced Degradation, Informa Health Sciences, Brussels, Belgium, Jan 29-30, 2009.
  58.  Alsante, K.M.,* and Baertschi, S.W. “Chemistry-Guided Approach to Degradation Studies”, oral presentation, 3rd Annual Conference on Forced Degradation, Informa Health Sciences, Brussels, Belgium, Jan 29-30, 2009.
  59.  Baertschi, S.W.*, and Alsante, K.M.* “The Chemistry of Drug Degradation”, 1-Day Organic Master Class, 3rd Annual Conference on Forced Degradation, Informa Health Sciences, Brussels, Belgium, Jan 31, 2009.
  60.  Baertschi, S.W.*, “Forced Degradation Studies and Genotoxic Impurities:  Scientific and Regulatory Issues”, invited oral presentation, Genotoxic Impurities Conference, hosted by the Institute for International Research, Philadelphia, PA, Dec 8-9, 2008.
  61.  Baertschi, S.W.* “Fundamentals of Photochemistry and Photostability Testing”, 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.
  62.  Smith, W.K., Jansen, P.J., Kiehl, D.E., Behme, R.J., and Baertschi, S.W.* “Drug Photodegradation in the Solid State: Unexpected Photochemistry Observed in a Lyophilized Product”, oral presentation at the Annual Meeting of the American Society for Photobiology, Burlingame, CA, June 2008.
  63.  Baertschi, S.W.*, Draper, J.R., Jansen, P.J., and Smith, William, K. “Oxidative Susceptibility Testing: Rapid, Comprehensive, Screening Techniques”, invited oral presentation, 2nd Annual Conference on Forced Degradation, Informa Health Sciences, Amsterdam, Netherlands, Jan 31, 2008.
  64.  Baertschi, S.W.*, and Alsante, K.M.* “Fundamentals of Photochemistry and Photostability Testing”, Organic Master Class, 2nd Annual Conference on Forced Degradation, Informa Health Sciences, Amsterdam, Netherlands, Jan 31, 2008.
  65.   Baertschi, S.W.*, and Alsante, K.M.* “The Chemistry of Drug Degradation”, 1-Day Organic Master Class, 2nd Annual Conference on Forced Degradation, Informa Health Sciences, Amsterdam, Netherlands, Jan 31, 2008.
  66.  Baertschi, S.W.*, Campbell, B.M., Draper, J.R., and Jansen, P.J. “Automating the Analytical Laboratory: Is it Worth the Effort?”, invited oral presentation at the 4th Annual Forced Degradation conference, hosted by the International Institute for Research, Las Vegas, NV, Jan 22-24, 2007.
  67.  Toltl, N, Baertschi, SW, Wozniak TJ, and Olsen, BA,* “Artifact Peaks in HPLC Impurity Analysis Caused by Trace Levels of Copper”, poster presentation at HPLC, San Francisco, CA, 2006.
  68.  Baertschi, S.W.* “Destroying Drugs for the Purpose of Bringing Them to Market: Pharmaceutical Stress Testing”, invited oral presentations at the University of Wisconsin- Madison and UW-Milwaukee, Sept. 28-29, 2006.
  69.  Baertschi, S.W., Campbell, B.M., Draper, J.R., and Jansen, P.J., “Implementing Automation in the Pharmaceutical Development Laboratory: The Symyx Automated Forced Degradation System,” Invited oral presentation at the Symyx User Group Meeting, Annapolis, MD, June 2006.
  70.  Baertschi, S.W.*, Draper, J.R., Jansen, P.J., and Smith, W.K., “Oxidative Susceptibility Testing: Rapid, Comprehensive Screening Techniques”, Invited oral presentation at the 3rd Annual Forced Degradation conference, Institute for International Research, Short Hills, NJ, Feb. 2006.
  71.  Baertschi, S.W.* “Destroying Drugs for the Purpose of Bringing Them to Market: Pharmaceutical Stress Testing”, invited oral presentation at the University of Oslo, Depts of Pharmaceutics and Chemistry, Oslo, Norway, November 2005.
  72.  Baertschi, S.W.* “Destroying Drugs for the Purpose of Bringing Them to Market: Pharmaceutical Stress Testing”, Short Course at Lehigh University, Bethlehem, PA, April 10, 2005.
  73. Baertschi, S.W.* “Forced Degradation and Its Relationship to Real Time Drug Product Stability”, APQ Open Forum, AAPS Annual Meeting, Nashville, TN, Nov 2005.
  74.  Baertschi, S.W.,* Campbell, B.M., Draper, J.R., Jansen, P.J., Maxwell, L.N., and Smith, W.K “Uncovering New Impurities by Investigating Mass Balance Issues Observed During Stress Testing Studies”, invited oral presentation, 5th Annual Impurities Summit, Institute for International Research, Princeton, NJ, May 18, 2005.
  75.  Baertschi, S.W.,* Campbell, B.M., Draper, J.R., Jansen, P.J., Maxwell, L.N., and Smith, W.K “. “Strategies for Assessing Mass Balance in Partially-Degraded Samples”, invited oral presentation “3rd Annual Forced Degradation Conference: Best Practices for the Pharmaceutical Industry, Institute for International Research, Washington, DC, Feb. 15, 2004.
  76.  Baertschi, S.W.,* and Alsante, K.M.* “The Chemistry of Drug Degradation”, oral presentation at the AAPS Sunrise School, AAPS National Meeting, Baltimore, MD, November 9, 2004.
  77.  Baertschi, S.W.,* Draper, J.R., Jansen, P.J., Maxwell, L.N., and Smith, W.K. “Oxidative Susceptibility Testing: Rapid, Comprehensive Screening Techniques”, Oxidative Degradation and Stabilization Conference, Institute for International Research, Princeton, NJ, July 20-21, 2004.
  78.  Baertschi, S.W.* “Strategies for Investigation and Control of Degradation-Related Impurities”, invited presentation at the FDA Impurities Workshop, Gaithersburg, MD, March 22 (2004).
  79.  Baertschi, S.W.* “Pharmaceutical Photostability: Sample Presentation”, 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).
  80.  Baertschi, S.W.,* Jansen, P.J., Maxwell, L.N., and Smith, W.K. “Strategies for Investigation and Control of Degradation-Related Impurities”, invited oral presentation, ACS Central Eastern Regional Meeting, Indianapolis, IN, June 2-4 (2004).
  81.  Baertschi, S.W.* and K.M. Alsante,* “The Chemistry of Drug Degradation”, oral presentation, Forced Degradation: Best Practices for the Pharmaceutical Industry, Institute for International Research, Princeton, NJ, Feb. 24-25 (2004).
  82.  Baertschi, S.W.,*, Nussbaum, M.A., Smith, W.K., and Jansen, P.J. “Strategies for Assessing Mass Balance in Partially-Degraded Samples”, invited oral presentation, AAI Stability Seminar, Wilmington, NC, March 26-27, 2003.
  83.  Baertschi, S.W.,* Nussbaum, M.A., Smith, W.K., and Jansen, P.J., “Strategies for Assessing Mass Balance in Partially-Degraded Samples”, invited oral presentation, Detecting, Identifying, and Quantitating Impurities, Institute for International Research, Princeton, NJ, May 20-21, 2002.
  84. Baertschi, S.W.* “Destroying Drugs for the Purpose of Bringing Them to Market: Pharmaceutical Stress Testing”, 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.
  85. Baertschi, S.W.,* “ICH Option 1 and Option 2 Sources: Potential for Different Photodegradation Pathways”, oral presentation, Photostability 01: 4th International Conference on the Photostability of Drug Substances and Drug Products,  Research Triangle Park, NC, July 16-19 (2001).
  86. Baertschi, S.W.*, “Pharmaceutical photostability testing: sample presentation”, invited oral presentation, Photostability 01: 4th International Conference on the Photostability of Drug Substances and Drug Products,  Research Triangle Park, NC, July 16-19, 2001.
  87. Baertschi, S.W.*, “Strategies for Investigation and Control of Process-Related Impurities”, invited oral presentation, Detecting, Identifying, and Quantitating Impurities, Institute for International Research, Philadelphia, PA, March 27-28, 2001.
  88. Baertschi, S.W.*, “Current Trends in Photostability 1 –  Practical Considerations in Designing and Implementing Photostability Studies”, invited oral presentation, Stability of Pharmaceuticals: Current Issues, Practices, and Technologies, University of Wisconsin-Madison Seminar Series, Costa Mesa , CA, November 13-14, 2000.
  89. Allen, J.M.,* Allen S.A., Dreiman, J., and Baertschi, S.W. “2-Nitrobenzaldehyde: A Convenient UV-A and UV-B Chemical Actinometer for Drug Photostability Testing”, oral presentation at ” Photostability ’99, joint meeting with 27th Annual Meeting of the American Society for Photobiology, Washington, DC, July 10-15, 1999.
  90. Baertschi, S.W., Kinney H.D., Snider, B.G.* “Issues in Evaluating the ‘In-Use’ Photostability of Transdermal Patches”, oral presentation, Photostability ’99, joint meeting with 27th Annual Meeting of the American Society for Photobiology, Washington, DC, July 10-15, 1999.
  91. Baertschi, S.W.*  “Designing and Implementing Photostability Studies in Alignment with ICH Guidelines”, invited oral presentation, Statistical Methods for Determining and Justifying Your Specifications and Shelf-Life”, Institute for International Research, Bethesda, MD, Sept. 22-24, 1999.
  92. Baertschi, S.W.*  “Practical Aspects of Pharmaceutical Photostability Testing”, Photostability ’99, invited oral presentation, joint meeting with 27th Annual Meeting of the American Society for Photobiology, Washington, DC, July 10-15, 1999.
  93. Baertschi, S.W.*  “Designing and Implementing ICH-Compliant Photostability Studies”, invited oral presentation, Pharmaceutical Stability: Statistical Applications, Regulatory Updates, and Current Industry Practices”, AAI Seminar Series, East Brunswick, NJ, February 22-23, 1999.
  94. Baertschi, S.W.*  “Designing and Implementing Photostability Studies in Alignment with ICH Guidelines”, invited oral presentation, Preparing for Changing Paradigms in Pharmaceutical Stability Programs, Institute for International Research, Philadelphia, PA, September 16, 1998.
  95. Baertschi, S.W.*  “Designing and Implementing Photostability Studies in Alignment with ICH Guidelines”, invited oral presentation, Barnett-Parexel’s Conference on Stability Testing, Washington, DC, September 14, 1998.
  96. Baertschi, S.W.*  “Pharmaceutical Stress Testing”, invited oral presentation at Indiana State University-Terre Haute, Terre Haute, IN, March 17, 1998.
  97. Baertschi, S.W.*  “Destroying Drugs for the Purpose of Bringing Them to Market”, invited oral presentation at Rocky Mountain College, Billings, MT, Feb. 26, 1998.
  98.  Eckstein, M.,* Baertschi, S., Jansen, P., Maple, S., and Wozniak T., “A light-catalyzed formation of formaldehyde in a drug product”, AAPS Meeting, Boston, MA, Nov. 2, 1997.
  99.  Baertschi, S.W.*  “Photostability Testing:  Practical Issues Related to Sample Exposure”, invited oral presentation, Photostability, a 1997 Update; Scientific, Regulatory, and Practical Issues, AAI Seminar Series, Arlington, VA, February 24-25, 1997.
  100.  Baertschi, S.W.*  “The Role of Stress Testing in Method Development and Validation”, invited oral presentation, 1996 Calibration and Validation Symposium, Etobicoke, Ontario, October 2, 1996.
  101.  Baertschi, S.W.*  “The Role of Stress Testing in Pharmaceutical Product Development”, invited lecture, AAPS Midwest Regional Meeting, Chicago, IL, May 20, 1996.
  102.    Baertschi, S.W.* “Destroying Drugs for the Purpose of Bringing Them to Market:  Pharmaceutical Stress Testing”, invited lecture, Indiana University-Purdue University at Indianapolis (IUPUI), February 21, 1996.
  103. 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.
  104. Olsen, B.A.,* Baertschi, S.W., and Riggin, R.M.  “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.
  105.    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.
  106.    Brash, A.R.,* Baertschi, S.W., and Harris, T.M. “Non-cyclooxygenase Prostaglandin Biosynthesis:  Formation of PGA3 Isomers via an Allene Oxide”, Biological Oxidation Systems [Proc. Symp.] 2, pp. 683-693 (1990)
  107.    Stone, M.P.,* Harris, T.M., Baertschi, S.W., Byrd, S., Gopalakrishnan, S., and Raney K.D.  “Equilibrium and Covalent Binding of Aflatoxins with DNA”, Biophysical Journal, 33rd annual meeting, 1989, 55, 240a.
  108.    Harris, T.M.,* Baertschi, S.W., Raney, K.D., Gopalakrishnan, S., Byrd, S., and Stone, M.P.  “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.
  109.    Baertschi, S.W.,* Harris, T.M., Seibert, K., Wendelborn, D.F., and Roberts, L.J. II  “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.
  110.    Baertschi, S.W.,* Harris, T.M., and Brash, A.R.  “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
  1. 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. “Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and Commercialization”, Pharmaceutical Technology, Oct (2012)
  2. Alsante KM,* Martin, L., and Baertschi, SW* “A Stress Testing Benchmarking Study”, Pharmaceutical Technology, 27:2, pp. 60-72, February (2003).

*Corresponding author(s)

UNREFEREED PUBLICATIONS
  1. 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)
  2. Drug Manufacturers Endorse QbD Model for Drug Stability Submittals, The Gold Sheet.  Oct 11, (2007). (article by Joanne S. Eglovich)
  3. Baertschi, S.W.*, Jansen, P.J., and Ausman, D.  “Lilly Automation Takes the Stress out of Stress Testing”, Molecular Connection, Symyx newsletter, Fall issue (2008).
  4. Baertschi, S.W.,* and Alsante, K.M.* “Draft Concept Paper for Initiating Revision Process for ICH Q1B – Guideline for the Photostability Testing of New Drug Substances and Products”, presented to Robert Baum, Pfizer, the industry representative to ICH for the photostability guideline for review by the Expert Working group, February (2003).
  5. Dorman, D.E.* and Baertschi, S.W. “Degradation of Cefaclor”, Texas A&M Newsletter, “Note” (1991).

*Corresponding author(s)

BOOK CHAPTERS
  1. United States Pharmacopeia Impurities Expert Panel (Member, Baertschi SW et al.), “Impurities in Drug Substances and Drug Products”, USP General Chapter <1086>, Dec 2013.
  2.  United States Pharmacopeia Impurities Expert Panel (Member, Baertschi SW et al.), “Organic Impurities in Drug Substances and Drug Products”, USP Mandatory Chapter <476>, Dec 2013.
  3.  Tønnesen HH, and Baertschi SW, “Photoreactivity of drugs in vitro and in vivo”, book chapter published online at http://www.photobiology.info/ (2010).
  4. 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).
    • Introduction
    • Stress Testing: A Predictive Tool
    • The Chemistry of Drug Degradation
    • The Role of “Mass Balance” in Pharmaceutical Stress Testing
    • Stress Testing:  Frequently Asked Questions
    • Stress Testing: Relation to the Development Timeline
    • Stress Testing: Analytical Considerations
    • Stress Testing as a Predictive Tool for the Assessment of Potential Genotoxic
  5. Degradants Alsante, K.M., Baertschi, S.W., Coutant, M. Marquez, B.L., Sharp, T.R., and Zelesky, T.C., “Degradation and Impurity Analysis for Pharmaceutical Drug Candidates“, 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).
  6.  Baertschi, S.W., “Forced Degradation and Its Relationship to Real Time Drug Product Stability”, Proceedings from the AAPS Stability Workshop held in September 2007, Bethesda, MD, Huynh-Ba, K., Editor, Springer Publishing, New York (2009).
  7. Co-authored seven chapters in Pharmaceutical Stress Testing: Predicting Drug DegradationS.W. Baertschi, Editor, Taylor & Francis, New York (2005). 7  Introduction
    • Stress Testing: A Predictive Tool
    • The Chemistry of Drug Degradation
    • The Role of “Mass Balance” in Pharmaceutical Stress Testing
    • Stress Testing:  Frequently Asked Questions
    • Stress Testing: Relation to the Development Timeline
    • Stress Testing: Analytical Considerations
  8.  Tønnesen, H.H.,* and Baertschi, S.W. “Photostability testing:  the questions most frequently asked”, in Photostability of Drugs and Drug Formulations, 2nd edition, Tonnesen, H.H., Ed., CRC Press, Boca Raton, FL (2004).
  9.  Olsen, B.A.,* and Baertschi, S.W.* “Strategies for investigation and control of process-related and degradation-related impurities in pharmaceuticals”, in Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, Ahuja, S., and Alsante, K.M., Eds., volume 5 of “Separation Science and Technology”, Academic Press, (2003).
  10.  Baertschi, S.W.*, and Thatcher, S.R. “Sample presentation for photostability studies: problems and solutions”, in Pharmaceutical Photostability and Stabilization Technology, Piechocki, J., Editor, Taylor & Francis, New York, (2006).
  11.  Harris, T.M.,* Gopalakrishnan, S., Baertschi, S.W., Raney, K.D., Raney, V.M., Byrd, S., and Stone, M.P.  “Synthesis and Characterization of Aflatoxin B1 Epoxide and Its Adducts with Oligodeoxynucleotides” 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).
  12.  Guengerich, F.P.,* Shimada, T., Raney, K.D., Kim, D.-H., Baertschi, S.W., and Harris, T.M.  “Bioactivation of Aflatoxins and Sterigmatocystin by Human Liver Cytochrome P-450 Enzymes” 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).
  13.  Brash, A.R.,* Baertschi, S.W., Ingram, C.D., and Harris. T.M. “Allene Oxides as Intermediates in Biosynthesis of Ketols and Cyclopentenones”  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
  1.  JournalTrends in Analytical Chemistry, Special Issue on Drug Stability, Baertschi SW and Gorog S, Editors, Sept (2013).
  2.  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)
  3.  BookPharmaceutical 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)