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Metabolite Safety in Drug Development
Suzanne L. Iverson
€ 210.25
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Description for Metabolite Safety in Drug Development
Hardcover. 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. Editor(s): Iverson, Suzanne L.; Smith, Dennis A. Num Pages: 352 pages. BIC Classification: TDCW. Category: (P) Professional & Vocational. Dimension: 242 x 158 x 23. Weight in Grams: 618.
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 ... Read more
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 ... Read more
Product Details
Publisher
John Wiley & Sons Inc United States
Number of pages
352
Format
Hardback
Publication date
2016
Condition
New
Number of Pages
352
Place of Publication
New York, United States
ISBN
9781118949658
SKU
V9781118949658
Shipping Time
Usually ships in 7 to 11 working days
Ref
99-26
About Suzanne L. Iverson
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 ... Read more
Reviews for Metabolite Safety in Drug Development
"Written by individuals who collectively possess hundreds of years of experience within the drug metabolism field, the wealth of information and insight contained is amazing. The purpose of the tome is to provide the reader with, �... a comprehensive overview of why and how metabolites are studied during drug development in the pharmaceutical industry� (page 13). This objective is certainly ... Read more