LEADER 02910nam 2200433 450 001 9910677344203321 005 20230126215505.0 010 $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 $a20221231d2022 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aFundamentals of drug development /$fJeffrey S. Barrett 210 1$aHoboken, New Jersey :$cWiley,$d[2022] 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 $aPharmacology 615 0$aPharmacology. 676 $a615.10724 700 $aBarrett$b Jeffrey S.$01345072 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910677344203321 996 $aFundamentals of drug development$93070469 997 $aUNINA LEADER 05864oam 2200589M 450 001 9910800049903321 005 20230126204629.0 010 $a1-351-28038-4 010 $a1-351-28039-2 010 $a1-351-28040-6 010 $a1-907643-01-X 035 $a(CKB)2670000000056541 035 $a(EBL)1741775 035 $a(SSID)ssj0000778897 035 $a(PQKBManifestationID)11491415 035 $a(PQKBTitleCode)TC0000778897 035 $a(PQKBWorkID)10768022 035 $a(PQKB)11008406 035 $a(MiAaPQ)EBC1741775 035 $a(Au-PeEL)EBL1741775 035 $a(CaPaEBR)ebr10650055 035 $a(OCoLC)828743137 035 $a(OCoLC)1004350090 035 $a(OCoLC-P)1004350090 035 $a(FlBoTFG)9781351280402 035 $a(EXLCZ)992670000000056541 100 $a20170919d2017 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 10$aTotal Responsibility Management $ethe Manual /$fSandra Waddock 205 $aFirst edition. 210 1$aLondon :$cTaylor and Francis,$d2017. 215 $a1 online resource (194 p.) 300 $aDescription based upon print version of record. 311 $a1-874719-98-5 320 $aIncludes bibliographical references and index. 327 $aFront cover; About the authors; Title page; Copyright page; Contents; Acknowledgements; List of boxes, figures and tables; 1. What is responsibility management? And why bother?; 2. The business case for responsibility management: the new business imperative; 3. Building integrity and sustainability systemically; 4. Inspiration: vision setting and commitment processes; 5. Integration; 6. Improvement and innovation systems; 7. Indicators measuring responsibility management; 8. Getting started: change management and the complexity of being ""glocal""; References; Index; Back cover 330 2 $a"Almost every manager today knows that satisfying customers by meeting their quality demands is a critical component of business success. Quality management is a given in modern companies - a competitive imperative. Yet it was not always so. Back when the quality movement was getting started, few managers really understood either the importance of quality to customers or how to manage for quality. Much the same could be said today about managing responsibility. Why and how should responsibility be managed? What is responsibility management? Total Responsibility Management answers these questions while at the same time providing a systemic framework for managing a company's responsibilities to stakeholders and the natural environment that can be applied in a wide range of contexts. This framework uses managerial familiarity with quality management to illustrate the drivers for responsibility management. Companies know that product or service quality affects their customer relationships and the trust customers have in the company's products and services. So, too, a company's management of its responsibilities to other constituencies affects its relationships with those other stakeholders and the natural environment. But why bother? The answer is quite simple. Never has it been easier for employees, reporters, activists, investors, community members, the media and other critical observers to find fault with companies and their subsidiaries. A problem identified, even in a remote region or within a remote supplier, can instantaneously be transmitted around the world at the click of a mouse. Ask footwear, toy, clothing and other highly visible branded companies what their recent experience with corporate critics has been and they will tell you about the need to manage their stakeholder responsibilities (human rights, labour relations, environmental, integrity-related) or face significant consequences in the limelight of public opinion. Managers will discover that whether they do it consciously or not, they are already managing responsibility, just as companies were already managing quality when the quality movement hit. This manual makes the process of managing responsibilities to and relationships with stakeholders and nature explicit. Making the process explicit is important because too few of today's decisions-makers yet understand how they are managing stakeholder responsibilities as well as they understand how to manage quality. Managing responsibilities goes well beyond traditional 'do good' or discretionary activities associated with philanthropy and volunteerism, which are frequently termed 'corporate social responsibility'. In its broadest sense, responsibility management means taking corporate citizenship seriously as a core part of the way the company develops and implements its business model. The specifics of responsibility management are unique to each company, its industry, its products and its stakeholders, yet, as this manual illustrates, a general approach to managing responsibility is feasible - indeed, is increasingly necessary. Based on work undertaken by Boston College and the International Labour Office, Total Responsibility Management is the first CSR manual. Its original case studies add value to a range of tools and exercises that will make it required reading for all managers in need of a practical guide to managing responsibility and to students and researchers looking for an overarching framework to contextualise the changing responsibilities of global business."--Provided by publisher. 606 $aSocial responsibility of business 615 0$aSocial responsibility of business. 676 $a658.4083 700 $aWaddock$b Sandra$0953514 701 $aBodwell$b Charles$01587553 801 0$bOCoLC-P 801 1$bOCoLC-P 906 $aBOOK 912 $a9910800049903321 996 $aTotal Responsibility Management$93875655 997 $aUNINA