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Research Article

Meta-Analysis: Its Role in New Drug Applications and Aids Drug Studies

Pages 13-33 | Published online: 28 Sep 2008

References

  • Federal Food, Drug and Cosmetic Act, As Amended. U. Government Printing Office, Washington, DC 1975; 43, Section 505(d), The January 1975 edition includes all amendments through August, 1972
  • Code of Federal Regulations. U. Government Printing Office, Washington, DC 1988; 120–122, Title 21: Food and Drugs, Parts 300–499, Section 314 25 14 26, revised as of April 1, 1988
  • Guideline for the Format and Content of the Clinical and Statistical Sections of an Application. Center for Drug Evaluation and Research, Food and Drug Administration, Department of Health and Human Services. 1988
  • Federal Register Part IV, Vol 53, No. 204, 21 CFR Parts 312 and 314. Department of Health and Human Services, Food and Drug Administration. October 21, 1988, Friday
  • Dubey S. (1984) On the Combinability of Results from Multicenter Trials. Presented at the XIIth Inotnrrctiotlrl Biometric Conference on, TokyoJapan, September, 71984, 1–33
  • Dubey S. (1985) Documentation and Analysis of Adverse Drug Reactions Data for Controlled Clinical Trials. Proceedings of the Biopharmaceutical Section of the American Statistical Association. 1985, 25–29
  • Hedges L., Olkin I. Statistical Methods for Meta-Analyses. Academic Press, Inc. 1985
  • O'Neill R. Assessment of Safety, Biopharmaceutical Statistics for Drug Development, E. Peace Karl. Marcel Dekker, Inc., , NY 1988; 543–604
  • Ellenberg S. Meta-Analysis: The Quantitative Approach to Research Review. 1988, Unpublished paper
  • Thacker S. Meta-Analysis: A Quantitative Approach to Research Integration. JAMA 1988; 259(11)1685–1689, March 18, 1988
  • Random House N. The Random House Dictionary of the English Language (Unabridged Edition). 1977
  • Webster's Dictionary of the English Language, Unabridged, (Encyclopedia Edition). Webster's Press, New York 1977

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