Metabolite Safety in Drug Development

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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