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 39331 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 51737 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