Steven Baertschi - Academia.edu (original) (raw)
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Papers by Steven Baertschi
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Trends in Analytical Chemistry, Sep 1, 2013
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Drugs and the pharmaceutical sciences, Jun 24, 2005
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Organic Process Research & Development, May 15, 2015
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Pharmaceutical Stress Testing, 2016
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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).
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Journal of Pharmaceutical Sciences, Sep 1, 2015
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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.
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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
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ChemInform, Oct 3, 1989
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Bookmarks Related papers MentionsView impact
Bookmarks Related papers MentionsView impact
Bookmarks Related papers MentionsView impact
Trends in Analytical Chemistry, Sep 1, 2013
Bookmarks Related papers MentionsView impact
Drugs and the pharmaceutical sciences, Jun 24, 2005
Bookmarks Related papers MentionsView impact
Bookmarks Related papers MentionsView impact
Organic Process Research & Development, May 15, 2015
Bookmarks Related papers MentionsView impact
Bookmarks Related papers MentionsView impact
Pharmaceutical Stress Testing, 2016
Bookmarks Related papers MentionsView impact
Bookmarks Related papers MentionsView impact
Bookmarks Related papers MentionsView impact
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
Bookmarks Related papers MentionsView impact
Bookmarks Related papers MentionsView impact
Journal of Pharmaceutical Sciences, Sep 1, 2015
Bookmarks Related papers MentionsView impact
Bookmarks Related papers MentionsView impact
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
Bookmarks Related papers MentionsView impact
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
ChemInform, Oct 3, 1989
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Bookmarks Related papers MentionsView impact