2.6 — Nonclinical Written and Tabulated Summaries

Nonclinical written and tabulated summaries covering pharmacology, PK, and toxicology (100-150 pages for NDA)

Requirements by Phase

IND Phase 1: minimal IND Phase 2: minimal IND Phase 3: minimal NDA: required

Content Requirements

• 2.6.1 Introduction: scope and overview of nonclinical testing program
• 2.6.2 Pharmacology Written Summary: primary pharmacodynamics, secondary pharmacodynamics, safety pharmacology
• 2.6.3 Pharmacology Tabulated Summary: tabular presentation of all pharmacology studies
• 2.6.4 Pharmacokinetics Written Summary: analytical methods, absorption, distribution, metabolism, excretion, PK drug interactions, other PK studies
• 2.6.5 Pharmacokinetics Tabulated Summary: tabular presentation of all PK studies
• 2.6.6 Toxicology Written Summary: single-dose, repeat-dose, genotoxicity, carcinogenicity, reproductive/developmental, local tolerance, other toxicity studies, mechanistic studies
• 2.6.7 Toxicology Tabulated Summary: tabular presentation of all toxicology studies

Expected Deliverables

• Written summaries (pharmacology, PK, toxicology)
• Tabulated summaries (pharmacology, PK, toxicology)

Page guidance: 100-150 pages total

ICH Guidelines: ICH M4S

Note: NDA: 100-150 pages

Source: ICH M4S