04058nam 22006014a 450 991084178390332120230828213302.01-280-54982-397866105498250-470-04340-70-470-04339-3(CKB)1000000000355351(EBL)270458(OCoLC)476004231(SSID)ssj0000159870(PQKBManifestationID)11163367(PQKBTitleCode)TC0000159870(PQKBWorkID)10158686(PQKB)11401578(MiAaPQ)EBC270458(EXLCZ)99100000000035535120060516d2006 uy 0engur|n|---|||||txtccrFundamentals of early clinical drug development[electronic resource] from synthesis design to formulation /edited by Ahmed F. Abdel-Magid and Stéphane CaronHoboken, N.J. Wiley-Intersciencec20061 online resource (341 p.)Description based upon print version of record.0-471-69278-6 Includes bibliographical references and index.Reflections on process research II / Edward J.J. Grabowski -- Development and scale-up of a heterocyclic cross-coupling for the synthesis of 5-(2-(3-methyl-3H-imidazol-4-yl)thieno(3,2-b)pyridin-7-yl)amino-2-methyl-1H-indol / John A. Ragan -- Large-scale enantioselective preparation of 2E,7E, 5S,6R, 5-hydroxy-6-methyl-8-phenyl-octa-2,7-dienoic acid, a key fragment for the formal total synthesis of the anti-tumor agent cryptophycin 52 / James Aikins ... [et al.] -- Efforts toward a commercially viable route and process to the synthesis of HIV PI GW640385X / John C. Roberts ... [et al.] -- Development of an asymmetric synthesis of ABT-100 / Albert W. Kruger ... [et al.] -- Asymmetric hydrogenation: a new route to pregabalin / Rex Jennings ... [et al.] -- Responsibilities of the process chemist: beyond synthetic organic chemistry / Stéphane Caron -- Outsourcing: the challenge of science, speed, and quality / Simone Andler-Burzlaff, Jason Bertola, and Roger E. Marti -- Automation and the changing face of process research in the pharmaceutical industry / Edward J. Delaney ... [et al.] -- Large scale synthesis: an engineering perspective / Joseph H. Childers, Jr. -- Synthesis and application of radioisotopes in pharmaceutical research and development / Larry E. Weaner and David C. Hoerr -- Selection of the drug form in exploratory development / George J. Quallich -- Strategies to control particle size of active pharmaceutical ingredients / David J. am Ende and Peter R. Rose -- Challenges in early formulation: turning drug substance into drug product / Mark H. Kleinman and Beeah Lee -- Intellectual property and early development / Maria I. Shchuka.An informative look at the intricacies of today's drug development processOnce a discovery organization has identified a potential new drug candidate, it is the daunting task of synthetic organic chemists to identify the chemical process suitable for preparation of this compound in a highly regulated environment. Only through a multi-layered chemical process that takes into account such factors as safety, environmental considerations, freedom to operate and cost-effectiveness can researchers begin to refine the drug in terms of quality and yield.This book covers both reClinical pharmacologyPharmaceutical technologyDrugsTestingClinical pharmacology.Pharmaceutical technology.DrugsTesting.615.1615.19615/.1Abdel-Magid Ahmed F.1947-1728411Caron Stéphane1613934MiAaPQMiAaPQMiAaPQBOOK9910841783903321Fundamentals of early clinical drug development4136952UNINA