PART 4: CLINICAL DOCUMENTS (EFFICACY DOCUMENTATION)

A : Table of Contents

A table of contents for the filed application should be provided.

B : Pre-Clinical Documentation
B1 : Pharmacology
B2 : Target Species Tolerance
B3 : Resistance
C: Clinical Documentation
C1: Summary of the Results and Critical Evaluation of Dose Determination and Dose Confirmation Studies and Clinical Trials
C2: Tabular Presentation of All Clinical Trials and Studies
C3: Individual Summary of the Most Important and Significant Studies
C4: Summary of Clinical Safety

National Pharmaceutical Regulatory Agency (NPRA)
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