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10/12/99


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Table of Contents

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Questions

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Motivation

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Statistical Issues

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Summary Information

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Methylphenidate TIACC Report 87 TI 09 (1988)

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Case Study 1 Non-replicate Bioequivalence Studies

Case Study 1 Frequency of ANOVA CV (RMSE)

Case Study 2 Study Population (Gender Effect)

Case Study 2. Gender-by-Formulation Interaction

Case Study 3 Study Population (Age Effect)

Case Study 3. Age Effect

S*F Evidence

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General Guidance Non-Replicate Studies Allowed

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FDA Proposal

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Author: CDER User