11 Site Management 127
Barry Miskin
12 Good Clinical Practices 139
Wendy Bohaychuk and Graham Ball
13 Quality Assurance, Quality Control and Audit 159
Rita Hattemer-Apostel
14 The Unique Role of Over-the-Counter Medicine 179
Paul Starkey
SECTION III: SPECIAL POPULATIONS AND REQUIRED SPECIAL STUDIES 191
Introduction 19115 Drug Research in Older Patients 193
Lionel D. Edwards
16 Drug Development Research in Women 203
Lionel D. Edwards
17 Clinical Research in Children 223
Lionel D. Edwards
18 Racial and Ethnic Issues in Drug Registration 231
Lionel D. Edwards, J.M. Husson, E. Labbe ́, C. Naito, M. Papaluca Amati,
S. Walker, R. Williams and H. Yasurhara
19 Hepatic and Renal Failure 249
Anthony W. Fox
20 Drug Interactions 255
Anthony W. Fox and Anne-Ruth van Troostenburg de Bruyn
21 Orphan Drugs 265
Bert Spilker
SECTION IV: APPLIED ASPECTS OF DRUG DEVELOPMENT 277
Introduction 27722 Biotechnology Products and Development 279
David A. Shapiro and Anthony W. Fox
23 Pharmacoeconomics: Economic and Humanistic Outcomes 291
Raymond J. Townsend, Jane T. Osterhaus and J. Gregory Boyer
24 Pharmacoepidemiology and the Pharmaceutical Physician 303
Hugh H. Tilson
25 Statistical Principles and Application in Biopharmaceutical Research 313
Dan Anbar
26 Data Management 345
T.Y. Lee and Michael Minor
vi CONTENTS