The New Drug Approvals of 1996, 1997, and 1998: Drug Development Trends in the User Fee Era Kenneth I. KaitinElaine M. Healy OriginalPaper 30 December 2000 Pages: 1 - 14
The Significance of Quality for Efficacy and Safety of Herbal Medicinal Products Werner Busse OriginalPaper 30 December 2000 Pages: 15 - 23
Immunotoxicity Evaluation and Guidelines for Drug Approval in Korea Young-Ok KimHyejoo ChungDae-Hyun Cho OriginalPaper 30 December 2000 Pages: 25 - 32
The Revised Principles of Good Laboratory Practice of the Organisation for Economic Cooperation and Development—Changes, Chances, and Controversies Hedwig BeernaertSergio CaroliDian Turnheim OriginalPaper 30 December 2000 Pages: 33 - 45
The Burden of Illness of Employees on United States Employers: A Critical Review of the Literature Devidas MenonLila Assiff OriginalPaper 30 December 2000 Pages: 47 - 58
Contents and Quality Control of Ambulatory Electrocardiographic (Holter) Reports and Data Timothy S. CallahanElizabeth Charuvastra OriginalPaper 30 December 2000 Pages: 59 - 68
North Carolina Physician Access to Drug Information Resources Catherine Curren RheneyWesley G. ByerlyJulie F. Connelly OriginalPaper 30 December 2000 Pages: 69 - 73
The Ability of the Association Française Contre les Myopathies to Promote Research in Neuromuscular Diseases J. Andoni Urtizberea OriginalPaper 30 December 2000 Pages: 75 - 78
Partnerships Between the Pharmaceutical Industry and Patient Groups: The Patients’ View Stéphane Korsia OriginalPaper 30 December 2000 Pages: 79 - 81
Partnerships between the Pharmaceutical Industry and Patient Groups: A Company Example Larry K. Powe OriginalPaper 30 December 2000 Pages: 83 - 85
Project Management Performance Measures in a Regulatory Environment: An Initial Examination Steven H. Chasin OriginalPaper 30 December 2000 Pages: 87 - 90
Pharmacy Student Clerkship Industry Rotation in Drug Information: The Searle Global Healthcare Resources Experience Susan E. MalechaAmy J. ChaRobert J. Holt OriginalPaper 30 December 2000 Pages: 91 - 96
Drug Information Coordination for a Copromoted Product Charles F. CurranMurali N. SundarMonica Patel OriginalPaper 30 December 2000 Pages: 97 - 101
Attitudinal Dimensions that Determine Pharmacists’ Decisions to Support DTCA of Prescription Medication Shane Paul DesselleRajender Aparasu OriginalPaper 30 December 2000 Pages: 103 - 114
Guest Editor’s Note: The Synergistic Relationship of Computers and Medical Science in the Twenty-First Century: Impact on Biopharmaceutical Drug Development Ronald D. Fitzmartin OriginalPaper 30 December 2000 Pages: 115 - 116
Challenges and Solutions for the Use of Remote Study Monitoring in a Transcontinental Project Johann Pröve OriginalPaper 30 December 2000 Pages: 121 - 127
Use of Pen-Based Electronic Diaries in An International Clinical Trial of Asthma Brian TipladyAudrey H. JamiesonGraham K. Crompton OriginalPaper 30 December 2000 Pages: 129 - 136
User Preferences for Computer Administration of Quality of Life Instruments Joseph A. CrawleyLeah KleinmanJason Dominitz OriginalPaper 30 December 2000 Pages: 137 - 144
Computer Assessment of Depression: Automating the Hamilton Depression Rating Scale Kenneth A. KobakJames C. MundtJames W. Jefferson OriginalPaper 30 December 2000 Pages: 145 - 156
Clinical Trial Design and Alterations in Drug Disposition with Age Michael L. ChristensenRussell W. ChesneyRichard A. Helms OriginalPaper 30 December 2000 Pages: 157 - 163
Successful Design and Conduct of a Treatment IND Program Celeste DiJohnson OriginalPaper 30 December 2000 Pages: 165 - 172
Direct Medical Costing for Economic Evaluations: Methodologies and Impact on Study Validity Christopher EvansBruce Crawford OriginalPaper 30 December 2000 Pages: 173 - 184
Outcomes Research and Biotechnology Products: A European View T. Walley OriginalPaper 30 December 2000 Pages: 185 - 192
Guest Editor’s Note: The Pediatric Studies Initiative: Solution to Worldwide Need? Christopher-Paul Milne OriginalPaper 30 December 2000 Pages: 193 - 195
Drugs For Children: The World Situation Jane G. Schaller OriginalPaper 30 December 2000 Pages: 197 - 201
Needs and new Policies For Medicines for Children: The FDA, United States Incentives, and International Doings Paula Botstein OriginalPaper 30 December 2000 Pages: 203 - 205
The Pediatric Research Initiative in the United States: Implications for Global Pediatric Research J. Gordon Still OriginalPaper 30 December 2000 Pages: 207 - 212
The Health of the World’s Children: What Goes Around, Comes Around Christopher-Paul Milne OriginalPaper 30 December 2000 Pages: 213 - 221
Pharmacogenomics: Future Promise of a Tool for Identifying Patients at Risk Janice H. Kurth OriginalPaper 30 December 2000 Pages: 223 - 227
Pharmacovigilance: Three Suggestions for Improving the Quantity and Quality of Adverse Event Reports R. A. P. Burt OriginalPaper 30 December 2000 Pages: 229 - 238
A Quality Management System for Pharmacovigilance Activities Jacqueline SayersDaphne Self OriginalPaper 30 December 2000 Pages: 239 - 243
Establishing A MedDRA Safety Surveillance Unit Thanh Van T. Doan OriginalPaper 30 December 2000 Pages: 245 - 250
Communicating The Frequency of Adverse Drug Reactions to Female Patients Duska M. FranicDev S. Pathak OriginalPaper 30 December 2000 Pages: 251 - 272
Evaluation of Safety Data from Controlled Clinical Trials: The Clinical Principles Explained John E. GaitSandy SmithSherri L. Brown OriginalPaper 30 December 2000 Pages: 273 - 287
Roles of Regulatory Project Managers in the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research Jean A. YagerDeborah L. Kallgren OriginalPaper 30 December 2000 Pages: 289 - 293
The Orphan Drug Act: Provisions and Considerations Carson R. Reider OriginalPaper 30 December 2000 Pages: 295 - 300
Preparing for FDA Advisory Committee Presentations: Perspective of an Advisory Committee Member Richard L. Schilsky OriginalPaper 30 December 2000 Pages: 301 - 304
What the Food and Drug Administration and the Pharmaceutical Industry Could Better Understand about Each Other Theresa L. Gerrard OriginalPaper 30 December 2000 Pages: 305 - 309
Regulation of Complementary Medicines—The Australian Experience Graham Peachey OriginalPaper 30 December 2000 Pages: 311 - 321
Nonprescription Drug Regulation in the United States Debra Bowen OriginalPaper 30 December 2000 Pages: 323 - 327
Legal Aspects on Medicinal Use of Hemp: Historic Overview and Present Policy of The Netherlands Willem K. Scholten OriginalPaper 30 December 2000 Pages: 329 - 332
Erratum to: The European Agency for the Evaluation of Medicinal Products’ Centralized Procedure for Product Approval: Current Status Elaine M. HealyKenneth I. Kaitin Erratum 30 December 2000 Pages: 333 - 333
