Title	Publication Date	Language	Citations
VigiBase, the WHO Global ICSR Database System: Basic Facts	2008/09/01	English	365
The Use of Biological Assays to Evaluate Botanicals	1998/04/01	English	305
Patient-Reported Outcomes: The Example of Health-Related Quality of Life—a European Guidance Document for the Improved Integration of Health-Related Quality of Life Assessment in the Drug Regulatory Process	2002/01/01	English	255
Assessment of Dose Proportionality: Report from the Statisticians in the Pharmaceutical Industry/Pharmacokinetics UK Joint Working Party	1995/07/01	English	212
Evaluation of the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets-1960 to 1999	2001/01/01	English	194
Recommendations for the Primary Analysis of Continuous Endpoints in Longitudinal Clinical Trials	2008/07/01	English	182
Practical Guidelines for Assessing the Clinical Significance of Health-Related Quality of Life Changes within Clinical Trials	2003/01/01	English	181
The Application of the Principle of Intention–to–Treat to the Analysis of Clinical Trials	1991/07/01	English	159
Statistical Methods for Comparison to Placebo in Active-Control Trials	2001/04/01	English	105
The Pursuit of Balance Using Stratified and Dynamic Randomization Techniques: An Overview	2003/07/01	English	101
Type I Error Rates from Mixed Effects Model Repeated Measures Versus Fixed Effects Anova with Missing Values Imputed Via Last Observation Carried Forward	2001/10/01	English	99
Adaptive Designs: Terminology and Classification	2006/10/01	English	88
Multiple Co-primary Endpoints: Medical and Statistical Solutions: A Report from the Multiple Endpoints Expert Team of the Pharmaceutical Research and Manufacturers of America	2007/01/01	English	88
Adaptive Seamless Phase II/III Designs—Background, Operational Aspects, and Examples	2006/10/01	English	80
A Method of Biased Coin Randomization, Its Implementation, and Its Validation	1998/04/01	English	77
Statistical Considerations for Multiplicity in Confirmatory Protocols	1996/04/01	English	77
Guidelines for Economic Evaluations in Italy: Recommendations from The Italian Group of Pharmacoeconomic Studies	2001/01/01	English	76
The Many Modes of Meta	2000/04/01	English	69
An Approach to Rationalize Partitioning Sample Size into Individual Regions in a Multiregional Trial	2008/03/01	English	69
Some Issues in the Design and Analysis of Equivalence Trials	1999/01/01	English	66
Quality Criteria and Standardization of Phytopharmaceuticals: Can Acceptable Drug Standards Be Achieved?	1998/01/01	English	65
Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development	2009/09/01	English	63
Handling Missing Data in Clinical Trials: An Overview	2000/04/01	English	63
Use of Fingerprinting and Marker Compounds for Identification and Standardization of Botanical Drugs: Strategies for Applying Pharmaceutical HPLC Analysis to Herbal Products	1998/04/01	English	62
Government Viewpoint of Clinical Trials	1982/01/01	English	61
Sample Size Reestimation: A Review and Recommendations	2006/10/01	English	58
Flexible Sample Size Considerations Using Information-Based Interim Monitoring	2001/10/01	English	58
R&D Costs and Returns by Therapeutic Category	2004/07/01	English	58
Individual Therapy: New Dawn or False Dawn?	2001/10/01	English	56
Intent-to-Treat Analysis versus As-Treated Analysis	1996/04/01	English	55