Items related to Metabolite Safety in Drug Development

Metabolite Safety in Drug Development - Hardcover

 
9781118949658: Metabolite Safety in Drug Development
Hardcover
ISBN 10: 111894965X ISBN 13: 9781118949658
Publisher: Wiley, 2016

Synopsis

A reference on drug metabolism and metabolite safety in the development phase, this book reviews the analytical techniques and experimental designs critical for metabolite studies. It features case studies of lessons learned and real world examples, along with regulatory perspectives from the US FDA and EMA.

•    Reviews the analytical techniques and experimental designs critical for metabolite studies
•    Covers methods including chirality, species differences, mass spectrometry, radiolabels, and in vitro / in vivo correlation
•    Discusses target pharmacology, in vitro systems aligned to toxicity tests, and drug-drug interactions
•    Includes perspectives from authors with firsthand involvement in industry and the study of drug metabolites, including viewpoints that have influenced regulatory guidelines

"synopsis" may belong to another edition of this title.

About the Author

Suzanne L. Iverson, PhD, ERT, earned her PhD studying reactive drug metabolites and idiosyncratic drug reactions (University of Toronto, Dr. Jack Uetrecht supervisor) and has worked in the pharmaceutical industry for over 14 years as principal scientist and manager of development in vitro/in vivo metabolism and distribution imaging as well as functional project leader for both DMPK and safety assessment functions. Since 2011, she has served on the management committee of the Drug Metabolism Discussion Group, UK, and the Board of the PK–Metabolism subcommittee of the Swedish Pharmaceutical Society.

Dennis A. Smith, PhD, currently holds part-time advisory and academic positions and, previously, worked in the pharmaceutical industry for 32 years. He has coauthored over 150 publications, including Attrition in the Pharmaceutical Industry (Wiley, 2016), Reactive Drug Metabolites (Wiley, 2012), and three editions of the book Pharmacokinetics and Metabolism in Drug Design (Wiley, 2012).

From the Back Cover

Metabolism is the primary method to clear a drug from the body, but the normal process can generate metabolites that have intrinsic chemical reactivity towards cellular molecules―and these metabolites remain free to circulate and exert both pharmacological and toxicological effects. Therefore, the study of drug metabolism occurs at all stages in the drug discovery and drug development process.

Targeting practitioners in all areas of nonclinical toxicology and clinical development, Metabolite Safety in Drug Development focuses on the characterization of metabolites once a drug candidate is selected, featuring case studies to illustrate lessons learned and a perspective on future directions. The book reviews the analytical techniques and experimental designs critical for metabolite studies, emphasizing stable and circulating metabolites, and deals with (on and off) target pharmacology, in vitro systems aligned with toxicity tests, and drug–drug interactions.

Deigned to provide a comprehensive resource that offers clear guidance on one of the most critical issues of drug development, this book has a number of key benefits:

• Description of analytical methods like chirality, species differences, mass spectrometry, radiolabels, and in vitro/in vivo correlation
• Presentation and assessment of regulatory requirements from the US FDA and EMA
• Perspectives from authors with firsthand involvement in industry and the study of drug metabolites, including viewpoints that have influenced regulatory guidelines

From the Inside Flap

Metabolism is the primary method to clear a drug from the body, but the normal process can generate metabolites that have intrinsic chemical reactivity towards cellular molecules—and these metabolites remain free to circulate and exert both pharmacological and toxicological effects. Therefore, the study of drug metabolism occurs at all stages in the drug discovery and drug development process.

Targeting practitioners in all areas of nonclinical toxicology and clinical development, Metabolite Safety in Drug Development focuses on the characterization of metabolites once a drug candidate is selected, featuring case studies to illustrate lessons learned and a perspective on future directions. The book reviews the analytical techniques and experimental designs critical for metabolite studies, emphasizing stable and circulating metabolites, and deals with (on and off) target pharmacology, in vitro systems aligned with toxicity tests, and drug–drug interactions.

Deigned to provide a comprehensive resource that offers clear guidance on one of the most critical issues of drug development, this book has a number of key benefits:

•    Description of analytical methods like chirality, species differences, mass spectrometry, radiolabels, and in vitro/in vivo correlation
•    Presentation and assessment of regulatory requirements from the US FDA and EMA
•    Perspectives from authors with firsthand involvement in industry and the study of drug metabolites, including viewpoints that have influenced regulatory guidelines

"About this title" may belong to another edition of this title.

Publisher
Wiley
Publication date
2016
Language
English
ISBN 10 
111894965X
ISBN 13 
9781118949658
Binding
Hardcover
Edition number
1
Number of pages
352
Editor
Iverson Suzanne L., Smith Dennis A.