Table of Contents

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.