STATISTICAL CONCEPTS IN THE PLANNING AND EVALUATION OF DRUG SAFETY FROM CLINICAL TRIALS IN DRUG DEVELOPMENT: ISSUES OF INTERNATIONAL HARMONIZATION

Author:

O'Neill Robert T.

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference15 articles.

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2. Department of Health and Human Services, Food and Drug Administration. ‘International Conference on Harmonization; Studies in Support of Special Populations; Geriatrics; Draft Guideline; Availability; Notice’, Federal Register, Part IX, 58, No. 72, pp. 21082–21083, 1993.

3. ‘Second International Conference on Harmonization, Session 1: Population Exposure to Assess Clinical Safety, Step 2 Draft Guidelines on the Extent of Population Exposure’, Orlando, Florida, 1993.

4. Department of Health and Human Services, Food and Drug Administration. ‘Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs; Notice’, Federal Register, Part IV, 58, No. 139, pp. 39406–39416, 1993.

5. The use of proportional hazards regression in investigating dropout rates in a longitudinal study

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