LEADER 03136nam 22004813 450 001 9910590095803321 005 20221226232047.0 010 $a1-119-91327-6 010 $a1-119-69173-7 010 $a1-119-69170-2 035 $a(MiAaPQ)EBC7045610 035 $a(Au-PeEL)EBL7045610 035 $a(CKB)24265995800041 035 $a(EXLCZ)9924265995800041 100 $a20220720d2022 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aFundamentals of drug development /$fJeffrey S. Barrett 210 1$aNewark :$cJohn Wiley & Sons, Incorporated,$d2022. 210 4$dİ2022. 215 $a1 online resource (512 pages) 320 $aIncludes bibliographical references and index. 327 $aThe history of drug development -- The modern pharmaceutical industry : big and small pharma, biotechnology companies, and generic drug makers -- Legal considerations, intellectual property, patents and patent protection -- The global regulatory landscape -- Phases of drug development : old and new paradigms -- Discovery / preclinical -- Phase I -- Phase II -- Phase III -- Phase IV, special populations and post marketing commitments -- Role and function of project teams -- Compound progression and go / no go criteria -- Regulatory milestones and the submission process -- Life cycle management -- Formulation development -- Chemistry and manufacturing (CMC) -- Health economics and the healthcare industry -- Current state of affairs : attrition rates and evolving corporate strategies -- Medical devices -- Distribution and the supply chain -- Sales, marketing and advertising -- Generic drugs and the generic industry -- The generic approval process -- Data sharing and collaboration -- The future of the pharmaceutical industry. 330 $a"This book discusses how to conduct pharmaceutical research and the context for how the industry fits into global healthcare. Holistically, the well-qualified author helps readers and students of drug development appreciate the time and expense of the process. Specifically, the work identifies the emerging trends shaping the future of drug development, along with important related topics like generic drugs, data sharing, and collaboration. To aid in seamless reader comprehension, the book includes a glossary of terms and a self-assessment quiz for each chapter at the end. PowerPoint slides are also available as an online ancillary for adopting professors"--$cProvided by publisher. 410 0$aWiley Online Library ebooks. 606 $aDrug development$xMethodology 606 $aPharmaceutical technology$xMethodology 606 $aDrugs$xResearch 608 $aebook$2local 615 0$aDrug development$xMethodology. 615 0$aPharmaceutical technology$xMethodology. 615 0$aDrugs$xResearch. 700 $aBarrett$b Jeffrey S.$01254771 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910590095803321 996 $aFundamentals of Drug Development$92908930 997 $aUNINA