Principles and practice of pharmaceutical medicine

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Front Matter -- Section I: Overview of Pharmaceutical Medicine. The Practice and Practitioners of Pharmaceutical Medicine / Anthony W Fox -- Pharmaceutical Medicine as a Medical Specialty / Michael D Young, Peter D Stonier -- Clinical Research Education and Training for Biopharmaceutical Staff / Peter Marks, Sheila Gwizdak -- Section II: Drug Discovery and Development. Part Introduction -- Section I: Drug Discovery and Development. Drug Discovery: Design and Development / Ronald R Cobb, Leslie J Molony -- Section II: Drug Discovery and Development. Translational Medicine, Pharmaceutical Physicians, Patients, and Payers / Robert Sands, Douglas Roy -- Pharmaceutics / Anthony W Fox -- Nonclinical Toxicology / Frederick Reno -- Informed Consent / Anthony W Fox -- Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure / Stephen H Curry, Helen H Decory, Johan Gabrielsson -- Phase II and Phase III Clinical Studies / Anthony W Fox -- Phase IV Drug Development: Post-Marketing Studies / Lisa R Johnson-Pratt -- Site Management / Barry Miskin -- Good Clinical Practices / Lionel D Edwards -- Quality Assurance, Quality Control and Audit / Rita Hattemer-Apostel -- The Unique Role of Over-the-Counter Medicine / Paul W Starkey -- Section III: Special Populations and Required Special Studies. Part Introduction -- Drug Research in Older Patients / Lionel D Edwards -- Drug Development Research in Women / Lionel D Edwards -- Clinical Research in Children / Lionel D Edwards -- Racial and Ethnic Issues in Drug Regulation / Lionel D Edwards, J-M Husson, E Labéb, C Naito, M Papaluca Amati, S Walker, R L Williams, H Yasurhara -- Special Populations: Hepatic and Renal Failure / Anthony W Fox -- Drug Interactions / Anthony W Fox, Anne-Ruth van Troostenburg -- Orphan Drugs / Bert Spilker -- QT Interval Prolongation and Drug Development / Bruce H Morimoto, Anthony W Fox -- Section IV: Applied Aspects. Part Introduction -- Biotechnology Products and Their Development / David A Shapiro, Anthony W Fox -- Health Economics / Daniel C Malone, Edward P Armstrong, Mirza I Rahman -- Pharmacoeconomics: Economic and Humanistic Outcomes / Raymond J Townsend, Jane T Osterhaus, J Gregory Boyer -- Pharmacoepidemiology and the Pharmaceutical Physician / Hugh H Tilson -- Statistical Principles and Application in Biopharmaceutical Research / Dan Anbar -- Data Management / T Y Lee, Michael Minor, Lionel D Edwards -- Patient Compliance: Pharmionics, A New Discipline / Jean-Michel éMtry -- Monitoring Drug Concentrations in Clinical Practice / Anthony W Fox -- Generics / Gabriel Lopez, Thomas Hoxie -- Complementary Medicines / Anthony W Fox -- Section V: Drug Regulation. Part Introduction -- United States Regulations / William Kennedy, Lionel D Edwards -- Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals / Anthony W Fox -- The Development of Human Medicines Control in Europe from Classical Times to the 21st Century / John P Griffin -- Medicines Regulation in the European Union / Anne-Ruth van Troostenburg, Giuliana Tabusso -- Japanese Regulations / Etienne Labéb -- Drug Registration and Pricing in the Middle East / Edda Freidank-Mueschenborn, Anja öKnig -- China's Regulated Pharmaceutical Market / Yan Yan Li Starkey -- India's New Era in Pharmaceuticals / Darshan Kulkarni -- Section VI: Medical Services. Part Introduction -- Medical Affairs / Gregory P Geba -- Drug Labeling / Anthony W Fox -- Data Mining / Mirza I Rahman, Robbert P van Manen -- Risk Management in Product Approval and Marketing / Anthony W Fox -- Publishing Clinical Studies / Anthony W Fox -- Organizing and Planning Local, Regional, National, and International Meetings and Conferences / Zofia Dziewanowska, Linda Packard -- When Things Go Wrong: Drug Withdrawals from the Market / Ronald D Mann -- International Trials: Successful Planning and Conduct / Katie P J Wood -- Section VII: Legal and Ethical Aspects of Pharmaceutical Medicine. Part Introduction -- Introduction to Bioethics for Pharmaceutical Professionals / Andrew J Fletcher -- Pharmaceutical Medicine and the Law / Sarah Croft -- Fraud and Misconduct in Clinical Research / Jane Barrett -- Section VIII: Business Aspects. Part Introduction -- The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-Commercial Environment / R Drucker, R Graham Hughes -- Advertising and Marketing / Jonathan Belsey -- Pharmaceutical Product Liability / Han W Choi, Jae Hong Lee -- Patents / Gabriel Lopez -- Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors / John R Vogel -- The Impact of Managed Care on the US Pharmaceutical Industry / Robert J Chaponis, Christine Hanson-Divers, Marilyn J Wells -- Appendix: Useful Web Links.

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Includes bibliographical references and index.

The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.