02858nam 2200601 450 991013504620332120180613003315.01-118-94967-61-118-94966-81-118-94968-4(CKB)4330000000007630(EBL)4585269(SSID)ssj0001695919(PQKBManifestationID)16541801(PQKBTitleCode)TC0001695919(PQKBWorkID)15015686(PQKB)25087556(MiAaPQ)EBC4585269(PPN)195753771(EXLCZ)99433000000000763020160802h20162016 uy 0engur|n|---|||||txtccrMetabolite safety in drug development /edited by Suzanne L. Iverson, Dennis A. SmithHoboken, New Jersey :Wiley,2016.©20161 online resource (350 p.)Description based upon print version of record.1-118-94965-X Includes bibliographical references and index.6.3.2 The First Clinical Studies"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"--Provided by publisher."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"--Provided by publisher.DrugsMetabolismDrugsSafety measuresPharmacologyDrugsMetabolism.DrugsSafety measures.Pharmacology.615.1SCI013010MED071000bisacshIverson Suzanne L.Smith Dennis A.MiAaPQMiAaPQMiAaPQBOOK9910135046203321Metabolite safety in drug development2246399UNINA