21 CFR Part 11: The role of predicate regulations and associated internal policies
Woodrum, Tammala D
Are the records maintained in …
Category: Drug Information Journal
Use of meta-analysis to evaluate medical questions of interest: An application to studies of secondary prevention of acute myocardial infarction…
Optimizing first-time-in-human trial design for studying dose proportionality
Yin, Yin
Mixed effect models are becoming common in an…
Evaluation of published case reports’ standards and notification
Ferguson, Jeffrey A
INTRODUCTION
POSTMARKETING ADVERSE event…
Integration and Structuring for Enhanced Knowledge Management*
Abbott, Robert
INTRODUCTION
Knowledge management has been the s…
current status of clinical trials in Malaysia, The
Lang, C C
Although Malaysia has a relatively long history of clinical research, i…
Some developments on the international index of erectile function (IIEF)
Cappelleri, Joseph C
INTRODUCTION
Male erectile dysf…
role of education in maintaining a healthy society, The
Adler, Madeleine Wing
Higher education supports four key goals in maintainin…
An overview of the regulatory approval process in drug development
Chow, Shein-Chung
This paper provides a brief history and an over…
