Advanced search
Publication Cover
Clinical Research and Regulatory Affairs Volume 13, 1996 - Issue 1
Journal homepage
14
Views
9
CrossRef citations to date
0
Altmetric
Research Article

Does Research Synthesis Have a Place in Drug Regulatory Policy? Synopsis of Issues: Assessment of Safety and Postmarketing Surveillance

Charles Anello Department of Biometrics Food, Drug Administration, Room 15B45, HFD-710 5600 Fishers Lane, Rockville, MD, 20852
&
Robert T. O'neill Office of Epidemiology and Biostatistics Center for Drug Evaluation and Research Food and Drug Administration, Room 15B45, HFD-710 5600 Fishers Lane, Rockville, MD, 20852
Pages 13-21 | Published online: 28 Sep 2008

Citations (9)

Keep up to date with the latest research on this topic with citation updates for this article.

Subscribe to citation updates

Read on this site (1)

Alexander J Sutton, Nicola J Cooper, Paul C Lambert, David R Jones, Keith R Abrams & Michael J Sweeting. (2002) Meta-analysis of rare and adverse event data. Expert Review of Pharmacoeconomics & Outcomes Research 2:4, pages 367-379.
Read now

Articles from other publishers (8)

Tarek A Hammad, Simone P Pinheiro & George A Neyarapally. (2011) Secondary use of randomized controlled trials to evaluate drug safety: a review of methodological considerations. Clinical Trials: Journal of the Society for Clinical Trials 8:5, pages 559-570.
Crossref
Su Golder, Yoon K. Loke & Martin Bland. (2011) Meta-analyses of Adverse Effects Data Derived from Randomised Controlled Trials as Compared to Observational Studies: Methodological Overview. PLoS Medicine 8:5, pages e1001026.
Crossref
Filip Mussen, Sam Salek & Stuart Walker. 2008. Benefit‐Risk Appraisal of Medicines. Benefit‐Risk Appraisal of Medicines 271 283 .
Staffan H??gg & Olav Spigset. (2002) Antipsychotic-Induced Venous Thromboembolism. CNS Drugs 16:11, pages 765-776.
Crossref
Alex Macario & Arthur G. Lipman. (2001) Ketorolac in the Era of Cyclo-Oxygenase-2 Selective Nonsteroidal Anti-Inflammatory Drugs: A Systematic Review of Efficacy, Side Effects, and Regulatory Issues. Pain Medicine 2:4, pages 336-351.
Crossref
Christy Chuang-Stein, Vu Le & William Chen. (2001) Recent Advancements in the Analysis and Presentation of Safety Data. Drug Information Journal 35:2, pages 377-397.
Crossref
Damian J. McEntegart. (2000) Pooling in Integrated Safety Databases. Drug Information Journal 34:2, pages 495-499.
Crossref
Charles Anello. (1999) Emerging and recurrent issues in drug development. Statistics in Medicine 18:17-18, pages 2301-2309.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.