Steven Baertschi - Academia.edu (original) (raw)

Uploads

Papers by Steven Baertschi

Research paper thumbnail of Characterizing drug degradation pathways through stress testing The complex degradation chemistry of cefaclor

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Sample Presentation for Photostability Studies: Problems and Solutions

Bookmarks Related papers MentionsView impact

Research paper thumbnail of The role of analytical chemistry in drug-stability studies

Trends in Analytical Chemistry, Sep 1, 2013

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Stress Testing

Drugs and the pharmaceutical sciences, Jun 24, 2005

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Practical aspects of pharmaceutical photostability testing

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Why Should We Care About Publishing?

Organic Process Research & Development, May 15, 2015

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Pharmaceutical Stress Testing

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Stress testing: Analytical considerations

Pharmaceutical Stress Testing, 2016

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Rapid stress stability studies for evaluation of manufacturing changes, materials from multiple sources, and stability-indicating methods

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Stress testing: Relation to the development timeline

Bookmarks Related papers MentionsView impact

Research paper thumbnail of ChemInform Abstract: Preparation of the 8,9-Epoxide of the Mycotoxin Aflatoxin B1: The Ultimate Carcinogenic Species

ChemInform, Feb 28, 1989

The title epoxide (II) (no yield given) is presumed to be the metabolite which is responsible for... more The title epoxide (II) (no yield given) is presumed to be the metabolite which is responsible for the mutagenic properties of aflatoxin B1 (I).

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Solid-state pharmaceutical development: Ensuring stability through salt and polymorph screening

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Stress testing: Frequently asked questions

Bookmarks Related papers MentionsView impact

Research paper thumbnail of 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

Journal of Pharmaceutical Sciences, Sep 1, 2015

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Preparation & NMR characterization of the covalent adduct of aflatoxin B1 epoxide with DNA

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Implementing an Accelerated Predictive Stability Program

Elsevier eBooks, 2018

Abstract This chapter provides an overview of the process and learnings that have occurred at Eli... more Abstract This chapter provides an overview of the process and learnings that have occurred at Eli Lilly and Company with regard to the evaluation, adoption, implementation, and continuous improvement of the ASAP approach for predicting and understanding stability. Implementation included developing thought leaders in key areas, incorporating them into an “ASAP Working Group,” and systematically communicating an understanding of the approach and the potential value that could be realized in the various areas of the organization. Key variables such as water activity, rapid humidity and temperature equilibration strategies, and methodology considerations are discussed. Efforts for continuous improvement of the approach are ongoing and are led by the ASAP Working Group. Case studies are provided for starting materials, intermediates, and final drug substance, as well as lyophilized and solid oral drug products.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Role of ‘‘mass balance’’ in pharmaceutical stress testing

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Stress testing: The chemistry of drug degradation

In this chapter, we will examine the major mechanisms of chemical decomposition of pharmaceutical... more In this chapter, we will examine the major mechanisms of chemical decomposition of pharmaceuticals in the context of common functional groups. The major mechanisms of chemical decomposition of pharmaceuticals include hydrolysis/dehydration, oxidation, isomerization/epimerization, decarboxylation, rearrangements, dimerization/polymerization, and photolysis and transformation products involving reaction with excipients/salt forms. In order to develop an understanding of the chemistry of such reactions, a basic knowledge of organic chemistry is needed. Providing such a background is not the purpose of this book, and therefore the reader may find it useful to

Bookmarks Related papers MentionsView impact

Research paper thumbnail of ChemInform Abstract: Formation of a Cyclopropyl Eicosanoid via an Allene Oxide in the Coral Plexaura homomalla: Implications for the Biosynthesis of 5,6-trans-Prostaglandin A2

ChemInform, Oct 3, 1989

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Automation in conducting stress testing and excipient compatibility studies

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Characterizing drug degradation pathways through stress testing The complex degradation chemistry of cefaclor

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Sample Presentation for Photostability Studies: Problems and Solutions

Bookmarks Related papers MentionsView impact

Research paper thumbnail of The role of analytical chemistry in drug-stability studies

Trends in Analytical Chemistry, Sep 1, 2013

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Stress Testing

Drugs and the pharmaceutical sciences, Jun 24, 2005

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Practical aspects of pharmaceutical photostability testing

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Why Should We Care About Publishing?

Organic Process Research & Development, May 15, 2015

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Pharmaceutical Stress Testing

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Stress testing: Analytical considerations

Pharmaceutical Stress Testing, 2016

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Rapid stress stability studies for evaluation of manufacturing changes, materials from multiple sources, and stability-indicating methods

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Stress testing: Relation to the development timeline

Bookmarks Related papers MentionsView impact

Research paper thumbnail of ChemInform Abstract: Preparation of the 8,9-Epoxide of the Mycotoxin Aflatoxin B1: The Ultimate Carcinogenic Species

ChemInform, Feb 28, 1989

The title epoxide (II) (no yield given) is presumed to be the metabolite which is responsible for... more The title epoxide (II) (no yield given) is presumed to be the metabolite which is responsible for the mutagenic properties of aflatoxin B1 (I).

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Solid-state pharmaceutical development: Ensuring stability through salt and polymorph screening

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Stress testing: Frequently asked questions

Bookmarks Related papers MentionsView impact

Research paper thumbnail of 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

Journal of Pharmaceutical Sciences, Sep 1, 2015

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Preparation & NMR characterization of the covalent adduct of aflatoxin B1 epoxide with DNA

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Implementing an Accelerated Predictive Stability Program

Elsevier eBooks, 2018

Abstract This chapter provides an overview of the process and learnings that have occurred at Eli... more Abstract This chapter provides an overview of the process and learnings that have occurred at Eli Lilly and Company with regard to the evaluation, adoption, implementation, and continuous improvement of the ASAP approach for predicting and understanding stability. Implementation included developing thought leaders in key areas, incorporating them into an “ASAP Working Group,” and systematically communicating an understanding of the approach and the potential value that could be realized in the various areas of the organization. Key variables such as water activity, rapid humidity and temperature equilibration strategies, and methodology considerations are discussed. Efforts for continuous improvement of the approach are ongoing and are led by the ASAP Working Group. Case studies are provided for starting materials, intermediates, and final drug substance, as well as lyophilized and solid oral drug products.

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Role of ‘‘mass balance’’ in pharmaceutical stress testing

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Stress testing: The chemistry of drug degradation

In this chapter, we will examine the major mechanisms of chemical decomposition of pharmaceutical... more In this chapter, we will examine the major mechanisms of chemical decomposition of pharmaceuticals in the context of common functional groups. The major mechanisms of chemical decomposition of pharmaceuticals include hydrolysis/dehydration, oxidation, isomerization/epimerization, decarboxylation, rearrangements, dimerization/polymerization, and photolysis and transformation products involving reaction with excipients/salt forms. In order to develop an understanding of the chemistry of such reactions, a basic knowledge of organic chemistry is needed. Providing such a background is not the purpose of this book, and therefore the reader may find it useful to

Bookmarks Related papers MentionsView impact

Research paper thumbnail of ChemInform Abstract: Formation of a Cyclopropyl Eicosanoid via an Allene Oxide in the Coral Plexaura homomalla: Implications for the Biosynthesis of 5,6-trans-Prostaglandin A2

ChemInform, Oct 3, 1989

Bookmarks Related papers MentionsView impact

Research paper thumbnail of Automation in conducting stress testing and excipient compatibility studies

Bookmarks Related papers MentionsView impact

Log In