Metabolite safety in drug development / / edited by Suzanne L. Iverson, Dennis A. Smith

• Pubblicazione: Hoboken, New Jersey : , : Wiley, , 2016; ©2016
• Descrizione fisica: 1 online resource (350 p.)
• Disciplina: 615.1
• Soggetto topico: Drugs - Metabolism; Drugs - Safety measures; Pharmacology
• Classificazione: SCI013010MED071000
• Persona (resp. second.): IversonSuzanne L.; SmithDennis A.
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references and index.
• Nota di contenuto: 6.3.2 The First Clinical Studies
• Sommario/riassunto: "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"--; "This book 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"--
• Titolo autorizzato: Metabolite safety in drug development
• ISBN: 1-118-94967-6; 1-118-94966-8; 1-118-94968-4
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910135046203321
• Lo trovi qui: Univ. Federico II