2.7 — Clinical Summary

Clinical summary: detailed summary of clinical pharmacology, efficacy, and safety (50-400 pages for NDA)

Requirements by Phase

NDA: required

Content Requirements

• 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods: bioavailability, comparative BA/BE, in vitro dissolution, analytical methods
• 2.7.2 Summary of Clinical Pharmacology Studies: PK, PD, PK/PD relationships, intrinsic/extrinsic factors, population PK
• 2.7.3 Summary of Clinical Efficacy: background, design of pivotal studies, efficacy results by study and across studies, subgroup analyses
• 2.7.4 Summary of Clinical Safety: exposure, adverse events, clinical laboratory evaluations, vital signs, ECG, special populations, overdose, drug abuse, withdrawal, post-marketing
• 2.7.5 Literature References: complete bibliography
• 2.7.6 Synopses of Individual Studies: structured synopsis of each clinical study per ICH E3

Expected Deliverables

• Clinical summary document (50-400 pages)

Page guidance: 50-400 pages

ICH Guidelines: ICH M4E

Note: NDA only. 50-400 pages

Source: ICH M4E