LEADER 03607nam 2200613Ia 450 001 9910140776803321 005 20220512052133.0 010 $a1-118-03520-8 010 $a1-283-91645-2 010 $a0-470-61319-X 010 $a0-470-61317-3 035 $a(CKB)2670000000034657 035 $a(EBL)573863 035 $a(OCoLC)659500821 035 $a(SSID)ssj0000416302 035 $a(PQKBManifestationID)11282729 035 $a(PQKBTitleCode)TC0000416302 035 $a(PQKBWorkID)10420911 035 $a(PQKB)11175514 035 $a(MiAaPQ)EBC573863 035 $a(Au-PeEL)EBL573863 035 $a(CaPaEBR)ebr10419057 035 $a(CaONFJC)MIL422895 035 $a(PPN)243325487 035 $a(EXLCZ)992670000000034657 100 $a20091104d2010 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aEarly drug development$b[electronic resource] $estrategies and routes to first-in-human trials /$fedited by Mitchell N. Cayen 210 $aHoboken, N.J. $cWiley$dc2010 215 $a1 online resource (658 p.) 300 $aDescription based upon print version of record. 311 $a0-470-17086-7 320 $aIncludes bibliographical references. 327 $aEARLY DRUG DEVELOPMENT; CONTENTS; Contributors; Foreword; Preface; PART I INTRODUCTION; 1 Drug Discovery and Early Drug Development; References; PART II LEAD OPTIMIZATION STRATEGIES; 2 ADME Strategies in Lead Optimization; 3 Prediction of Pharmacokinetics and Drug Safety in Humans; 4 Bioanalytical Strategies; PART III BRIDGING FROM DISCOVERY TO DEVELOPMENT; 5 Chemistry, Manufacturing, and Controls: The Drug Substance and Formulated Drug Product; 6 Nonclinical Safety Pharmacology Studies Recommended for Support of First-in-Human Clinical Trials; PART IV PRE-IND DRUG DEVELOPMENT 327 $a7 Toxicology Program to Support Initiation of a Clinical Phase I Program for a New Medicine8 Toxicokinetics in Support of Drug Development; 9 Good Laboratory Practice; PART V PLANNING THE FIRST-IN-HUMAN STUDY AND REGULATORY SUBMISSION; 10 Estimation of Human Starting Dose for Phase I Clinical Programs; 11 Exploratory INDs/CTAs; 12 Unique Considerations for Biopharmaceutics; 13 Project Management and International Regulatory Requirements and Strategies for First-in-Human Trials; 14 First-in-Human Regulatory Submissions; Appendix 1: Abbreviations and Acronyms 327 $aAppendix 2: Definitions and Glossary of TermsAppendix 3: Some Relevant Government and Regulatory Documents; Appendix 4: Some Relevant Resources with Web Sites; Index 330 $aThe focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to s 606 $aDrug development 606 $aClinical trials 615 0$aDrug development. 615 0$aClinical trials. 676 $a615/.19 701 $aCayen$b M. N$01223781 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910140776803321 996 $aEarly drug development$92839643 997 $aUNINA