LEADER 04062nam 22006014a 450 001 9910830297703321 005 20230828213302.0 010 $a1-280-54982-3 010 $a9786610549825 010 $a0-470-04340-7 010 $a0-470-04339-3 035 $a(CKB)1000000000355351 035 $a(EBL)270458 035 $a(OCoLC)476004231 035 $a(SSID)ssj0000159870 035 $a(PQKBManifestationID)11163367 035 $a(PQKBTitleCode)TC0000159870 035 $a(PQKBWorkID)10158686 035 $a(PQKB)11401578 035 $a(MiAaPQ)EBC270458 035 $a(EXLCZ)991000000000355351 100 $a20060516d2006 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aFundamentals of early clinical drug development$b[electronic resource] $efrom synthesis design to formulation /$fedited by Ahmed F. Abdel-Magid and Ste?phane Caron 210 $aHoboken, N.J. $cWiley-Interscience$dc2006 215 $a1 online resource (341 p.) 300 $aDescription based upon print version of record. 311 $a0-471-69278-6 320 $aIncludes bibliographical references and index. 327 $aReflections 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 / Ste?phane 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. 330 $aAn 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 re 606 $aClinical pharmacology 606 $aPharmaceutical technology 606 $aDrugs$xTesting 615 0$aClinical pharmacology. 615 0$aPharmaceutical technology. 615 0$aDrugs$xTesting. 676 $a615.1 676 $a615.19 676 $a615/.1 701 $aAbdel-Magid$b Ahmed F.$f1947-$01613933 701 $aCaron$b Ste?phane$01613934 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910830297703321 996 $aFundamentals of early clinical drug development$93943490 997 $aUNINA