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Papers by Steven Baertschi

Trends in Analytical Chemistry, Sep 1, 2013

Drugs and the pharmaceutical sciences, Jun 24, 2005

Organic Process Research & Development, May 15, 2015

studies for drug substance and drug product. This is the only guide available to tackle this subj... more studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years. Key features include: A renowned Editorial team and contributions from all major drug companies, q reflecting a wealth of experience. 10 new chapters, including Stress Testing and its relationship to the assessment q of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations Updated methodologies for predicting drug stability and degradation pathways q Best practice models to follow q An expanded Frequently Asked Questions section q This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).

Pharmaceutical Stress Testing, 2016

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).

Journal of Pharmaceutical Sciences, Sep 1, 2015

Although essential guidance to cover the photostability testing of pharmaceuticals for manufactur... more Although essential guidance to cover the photostability testing of pharmaceuticals for manufacturing and storage is wellestablished, there continues to be a significant gap in guidance regarding testing to support the effective administration of photosensitive drug products.

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.

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

ChemInform, Oct 3, 1989

ChemInform Abstract Incubation of arachidonic acid (I) with an acetone powder of the title coral ... more ChemInform Abstract Incubation of arachidonic acid (I) with an acetone powder of the title coral leads to the formation of the title cyclopropyl eicosanoid (III) (no yield given) and several other products. (III) is formed via the allene oxide (II) which is also a possible precursor of 5,6-trans-prostaglandins isolated from the title coral.

Trends in Analytical Chemistry, Sep 1, 2013

Drugs and the pharmaceutical sciences, Jun 24, 2005

Organic Process Research & Development, May 15, 2015

studies for drug substance and drug product. This is the only guide available to tackle this subj... more studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years. Key features include: A renowned Editorial team and contributions from all major drug companies, q reflecting a wealth of experience. 10 new chapters, including Stress Testing and its relationship to the assessment q of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations Updated methodologies for predicting drug stability and degradation pathways q Best practice models to follow q An expanded Frequently Asked Questions section q This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).

Pharmaceutical Stress Testing, 2016

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).

Journal of Pharmaceutical Sciences, Sep 1, 2015

Although essential guidance to cover the photostability testing of pharmaceuticals for manufactur... more Although essential guidance to cover the photostability testing of pharmaceuticals for manufacturing and storage is wellestablished, there continues to be a significant gap in guidance regarding testing to support the effective administration of photosensitive drug products.

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.

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

ChemInform, Oct 3, 1989

ChemInform Abstract Incubation of arachidonic acid (I) with an acetone powder of the title coral ... more ChemInform Abstract Incubation of arachidonic acid (I) with an acetone powder of the title coral leads to the formation of the title cyclopropyl eicosanoid (III) (no yield given) and several other products. (III) is formed via the allene oxide (II) which is also a possible precursor of 5,6-trans-prostaglandins isolated from the title coral.