Does research synthesis have a place in drug regulatory policy? Synopsis of issues: Assessment of safety and postmarketing surveillance

Clinical Research and Regulatory Affairs

Volumn 13, Issue 1, 1996, Pages 13-21

  Anello, Charles ^a   O'Neill, Robert T ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CONFERENCE PAPER; DRUG EFFICACY; DRUG LEGISLATION; DRUG MARKETING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; METHODOLOGY;

EID: 0029883618     PISSN: 10601333     EISSN: None     Source Type: Journal    
DOI: 10.3109/10601339609019625     Document Type: Conference Paper

References (8)

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2. O'Neill, R.T. Assessment of Safety in Biopharmaceutical Statistics. In: Biopharmaceutical Statistics for Drug Development, Peace K.E., ed. Marcel Dekker, New York, pp. 543-570, 1988.
3. Cochran, W.G. Planning and Analysis of Observational Studies. L.E. Moses and F. Mosteller, eds. John Wiley & Sons, New York, 1983.
4. Burkhart, G.A. Angiotensin Converting Enzyme Inhibitor-Associated Angioedema: Higher Risk in Blacks than Whites. Submitted for publication.
5. Hammaratrom, T., et al. Sedative-Hypnotic Drugs and the Risk of Hip Fracture. Psychopharmacologic Drugs Advisory Committee, May 19, 1992, FDA.
6. McKeigue, P.M., et al. Bendectin and Birth Defects: I. A MetaAnalysis of the Epidemiologic Studies. Teratology, 50, 27-37 (1994).
7. Fleiss, J.L., Gross, A.J. Meta-Analysis in Epidemiology, with Special Reference to Studies of the Association Between Exposure to Environmental, Tobacco Smoke and Lung Cancer: A Critique. J of Clin Epidemiol., 44,127-139 (1991).
8. Greenland, S. Quantitative Methods in the Review of Epidemiologic Literature. Epidemiol Rev, 9,1-30 (1987).