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 1Non-replicate Bioequivalence Studies
Case Study 1Frequency of ANOVA CV (RMSE)
Case Study 2Study Population (Gender Effect)
Case Study 2. Gender-by-Formulation Interaction
Case Study 3Study Population (Age Effect)
Case Study 3.Age Effect
S*F Evidence
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General GuidanceNon-Replicate Studies Allowed
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FDA Proposal
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