Principles and practice of pharmaceutical medicine / edited by Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier.

• 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 Labb̌, 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 M̌try -- 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 ₃Compassionate₄ 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 Labb̌ -- Drug Registration and Pricing in the Middle East / Edda Freidank-Mueschenborn, Anja K̲nig -- 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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Ämnesord

Drug development.  (LCSH)

Pharmacology.  (LCSH)

Drugs  -- Research. (LCSH)

Drug Evaluation.  (MeSH)

Drug Industry  -- organization & administration. (MeSH)

Genre

Electronic books.  (local)

Publikations- och innehållstyp

RM301.25 (LCC)

QV 736 (NLM)

615/.19 (DDC)

Pmca (kssb/8 (machine generated))