LEADER 04713nam 2200661Ia 450 001 9910816984703321 005 20230721023410.0 010 $a1-282-36844-3 010 $a9786612368448 010 $a0-470-46636-7 010 $a0-470-46635-9 035 $a(CKB)1000000000822085 035 $a(EBL)469409 035 $a(OCoLC)609848053 035 $a(SSID)ssj0000291823 035 $a(PQKBManifestationID)11238666 035 $a(PQKBTitleCode)TC0000291823 035 $a(PQKBWorkID)10253911 035 $a(PQKB)10289536 035 $a(MiAaPQ)EBC469409 035 $a(Au-PeEL)EBL469409 035 $a(CaPaEBR)ebr10346509 035 $a(CaONFJC)MIL236844 035 $a(EXLCZ)991000000000822085 100 $a20090210d2009 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aClinical trials handbook$b[electronic resource] /$fedited by Shayne Cox Gad 210 $aHoboken, NJ $cWiley$dc2009 215 $a1 online resource (1247 p.) 225 1 $aPharmaceutical Development Series ;$vv.8 300 $aDescription based upon print version of record. 311 $a0-471-21388-8 320 $aIncludes bibliographical references and index. 327 $aClinical Trials Handbook; Contents; Preface; Contributors; 1 Introduction to Clinical Trials; 2 Regulatory Requirements for Investigational New Drug; 3 Preclinical Assessment of Safety in Human Subjects; 4 Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies; 5.1 History of Clinical Trial Development and the Pharmaceutical Industry; 5.2 Adaptive Research; 6 Organization and Planning; 7 Process of Data Management; 8 Clinical Trials Data Management; 9.1 Clinical Trials and the Food and Drug Administration; 9.2 Phase I Clinical Trials; 9.3 Phase II Clinical Trials 327 $a9.4 Designing and Conducting Phase III Studies9.5 Phase IV: Postmarketing Trials; 9.6 Phase IV and Postmarketing Clinical Trials; 9.7 Regulatory Approval; 9.8 New Paradigm for Analyzing Adverse Drug Events; 10.1 Clinical Trials in Interventional Cardiology: Focus on XIENCE Drug-Eluting Stent; 10.2 Clinical Trials Involving Oral Diseases; 10.3 Dermatology Clinical Trials; 10.4 Emergency Clinical Trials; 10.5 Gastroenterology; 10.6 Gynecology Randomized Control Trials; 10.7 Special Population Studies (Healthy Patient Studies); 10.8 Musculoskeletal Disorders; 10.9 Oncology 327 $a10.10 Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration10.11 Paediatrics; 10.12 Clinical Trials in Dementia; 10.13 Clinical Trials in Urology; 10.14 Clinical Trials on Cognitive Drugs; 10.15 Bridging Studies in Pharmaceutical Safety Assessment; 10.16 Brief History of Clinical Trials on Viral Vaccines; 11 Methods of Randomization; 12 Randomized Controlled Trials; 13 Cross-Over Designs; 14.1 Biomarkers; 14.2 Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis; 15 Review Boards 327 $a16 Size of Clinical Trials17 Blinding and Placebo; 18 Pharmacology; 19 Modeling and Simulation in Clinical Drug Development; 20 Monitoring; 21 Inference Following Sequential Clinical Trials; 22 Statistical Methods for Analysis of Clinical Trials; 23 Explanatory and Pragmatic Clinical Trials; 24.1 Ethics of Clinical Research in Durg Trials; 24.2 Ethical Issues in Clinical Research; 25 Regulations; 26 Future Challenges in Design and Ethics of Clinical Trials; 27 Proof-of-Principle/Proof-of-Concept Trials in Drug Development; Index 330 $aBest practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of 410 0$aPharmaceutical Development Series 606 $aDrugs$xTesting$vHandbooks, manuals, etc 606 $aClinical trials$vHandbooks, manuals, etc 615 0$aDrugs$xTesting 615 0$aClinical trials 676 $a615.1 676 $a615.580724 676 $a615/.1 701 $aGad$b Shayne C.$f1948-$096171 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910816984703321 996 $aClinical trials handbook$94044352 997 $aUNINA