Principles and Practice of Pharmaceutical Medicine

(Elle) #1

27 Patient Compliance: Pharmionics, a New Discipline 355
Jean-Michel Me ́try


28 Monitoring Drug Concentrations in Clinical Practice 375
Anthony W. Fox


29 Generics 381
J.D. Gabriel Lopez and J.D. Thomas Hoxie


30 Complementary Medicines 387
Anthony W. Fox


SECTION V: DRUG REGULATION 393


Introduction 393

31 United States Regulations 395
William Kennedy


32 Special US Regulatory Procedures: Emergency and Compassionate INDs
and Accelerated Product Approvals 407
Anthony W. Fox


33 The Development of Human Medicines Control in Europe from Classical
Times to the Year 2000 415
John P. Griffin


34 Medicines Regulation in the European Union 443
Anne-Ruth van Troostenburg de Bruyn and Giuliana Tabusso


35 Japanese Regulations 487
Etienne Labbe ́


36 Drug Registration and Pricing in the Middle East 509
Edda Freidank-Mueschenbornfs


SECTION VI: MEDICAL SERVICES 517


Introduction 517

37 Medical Affairs 519
Gregory P. Geba


38 Drug Labeling 529
Anthony W. Fox


39 Drug Surveillance 535
Howard J. Dreskin and Win M. Castle


40 Data Mining 545
Mirza I. Rahman and Omar H. Dabbous


41 Risk Management in Product Approval and Marketing 557
Anthony W. Fox


CONTENTS vii
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