Submitting Biologics Applications to the Center for Biologics Evaluation and Research Electronically Mary A. BuesingEdward McSweegan OriginalPaper 30 December 1999 Pages: 1 - 15
The Contribution of the European Scientific Cooperative on Phytotherapy and World Health Organization Monographs Barbara Steinhoff OriginalPaper 30 December 1999 Pages: 17 - 22
Common Inspection Findings Related to the Investigator Brochure—A Regulatory View from the Medicines Control Agency Good Clinical Practice Inspection Unit Pamela Charnley Nickols OriginalPaper 30 December 1999 Pages: 23 - 25
Regulatory Status of Excipients in Japan Mitsuru Uchiyama OriginalPaper 30 December 1999 Pages: 27 - 32
The Regulatory Approval Process of Animal Drugs Stephen J. GilbrideMichael J. McGowan OriginalPaper 30 December 1999 Pages: 33 - 39
Facets of User-Friendliness: From Format to Content in Regulatory Submissions Jürg P. Seiler OriginalPaper 30 December 1999 Pages: 41 - 48
People, Paper, and Practices: How to Survive the Validation Process and Thrive on the Business Potential of Strategic Systems Teri Stokes OriginalPaper 30 December 1999 Pages: 49 - 61
The Effects of Shaded Areas of Case Report Forms on Facsimile Scanning Times Nathaniel Lim OriginalPaper 30 December 1999 Pages: 63 - 67
Medical Affairs and Drug Information Practices Within the Pharmaceutical Industry: Results of a Benchmarking Survey Fran HopkinsCassandra GalligherAbigail Levine OriginalPaper 30 December 1999 Pages: 69 - 85
Provision of Medical Information for Drugs Used in Orphan and Pediatric Disorders David A. Graves OriginalPaper 30 December 1999 Pages: 87 - 90
Clinical Data Management Requires Clean Data in the Coding Process Anna JakubowskaSonia SouzaChristian Fizames OriginalPaper 30 December 1999 Pages: 91 - 93
Developing A Knowledge Interface for A Document Management System Steven Agoratus OriginalPaper 30 December 1999 Pages: 95 - 99
Checks of Case Record Forms Versus the Database for Efficacy Variables When Validation Programs Exist Damian J. McEntegartSimon P. JadhavEdward J. Channon OriginalPaper 30 December 1999 Pages: 101 - 107
Some Issues in the Design and Analysis of Equivalence Trials Walter W. HauckSharon Anderson OriginalPaper 30 December 1999 Pages: 109 - 118
Global Two-Group Multiple Endpoint Adjustment Methods Applied to Clinical Trials A. J. SankohM. F. HuqueRalph B. D’Agostino, Sr OriginalPaper 30 December 1999 Pages: 119 - 140
Development of a Statistical Model for Prediction of Acute Myocardial Infarction by Biochemical Markers Tiepu LiuQiong WangW. Brian Gibler OriginalPaper 30 December 1999 Pages: 141 - 148
Sample Size Considerations for Assessing Vaccine Consistency Through Equivalence Brigitte CheuvartAnne Bollaerts OriginalPaper 30 December 1999 Pages: 149 - 151
Outcomes From Observational Studies: Understanding Causal Ambiguity Huw T. O. DaviespIain K. Crombie OriginalPaper 30 December 1999 Pages: 153 - 158
Using Cross-Functional Teams to Write Combined Clinical and Statistical Research Reports: A Communication Specialist’s Perspective Thomas J. Purcell OriginalPaper 30 December 1999 Pages: 159 - 163
Interim Analyses: An Update of an FDA Reviewer’s Experience and Perspective A. J. Sankoh OriginalPaper 30 December 1999 Pages: 165 - 176
Guest Editor’s Note: Randomized Controlled Trials and Outcomes Research Joseph C. Cappelleri OriginalPaper 30 December 1999 Pages: 177 - 178
Some Developments on the International Index of Erectile Function (IIEF) Joseph C. CappelleriRaymond C. RosenIan H. Osterloh OriginalPaper 30 December 1999 Pages: 179 - 190
Mixed-Model Imputation of Cost Data for Early Discontinuers from a Randomized Clinical Trial Robert L. ObenchainBryan M. Johnstone OriginalPaper 30 December 1999 Pages: 191 - 209
Exploring Heterogeneity in Randomized Trials Via Meta-Analysis Christopher H. Schmid OriginalPaper 30 December 1999 Pages: 211 - 224
Data Management Techniques Applied to the Scandinavian Simvastatin Survival Study (4S) Mega-Trial Nico De LeeuwAntonia WrightJohn C. Amos OriginalPaper 30 December 1999 Pages: 225 - 236
Monitoring Response to Treatment in the Development of Anti-Cancer Drugs Using Positron Emission Tomography (PET) Helen YoungCathryn BrockPat Price OriginalPaper 30 December 1999 Pages: 237 - 244
Clinical Methodology of Alzheimer’s Disease Trials Julian A. Gray OriginalPaper 30 December 1999 Pages: 245 - 252
Preparing a Clinical Site for a Clinical Investigator Inspection by the FDA Charles F. Curran OriginalPaper 30 December 1999 Pages: 253 - 259
Use and Abuse of Placebo in Clinical Trials D. J. Lyons OriginalPaper 30 December 1999 Pages: 261 - 264
One Large, Well-Designed, Multicenter Study as an Alternative to the Usual Fda Paradigm Lloyd D. Fisher OriginalPaper 30 December 1999 Pages: 265 - 271
An Automated Drug Concentration Screening and Quality Assurance Program for Clinical Trials Thaddeus H. GraselaEdward J. AntalSteven R. Cox OriginalPaper 30 December 1999 Pages: 273 - 279
Consumer Retention of Risk Information from Direct-to-Consumer Advertising Donald L. SullivanJon C. SchommerStephen W. Birdwell OriginalPaper 30 December 1999 Pages: 281 - 289
Complementary Medicine—Is It Effective And Safe? Edzard Ernst OriginalPaper 30 December 1999 Pages: 291 - 295
Harmonization of Pharmacopoeial Monographs and Test Methods Robin C. Hutton OriginalPaper 30 December 1999 Pages: 297 - 301
The Catalan Model of the Public Health System as a Framework for Carrying Out Experiences of Managed Care in Spain Eugeni Sedano OriginalPaper 30 December 1999 Pages: 303 - 307
Herbal Medicinal Products and Patients’ Needs in Europe Jean-François Dechamp OriginalPaper 30 December 1999 Pages: 309 - 313
Osteoporosis: Who, When, How Long to Treat, and with What Effectiveness? John A. Kanis OriginalPaper 30 December 1999 Pages: 315 - 319
Traditional Medicine Worldwide—The Role of Who Xiaorui Zhang OriginalPaper 30 December 1999 Pages: 321 - 326
Thinking Globally: Product Development, Registration, and Marketing in the New Millenium Keigo Danjoh OriginalPaper 30 December 1999 Pages: 327 - 332
