ICH Guideline Pharmacopoeial Text - Q4B
Channel: DR Technical Gyan
Date: 21/05/2020

INTRODUCTION
1.1 Objective(s) of the Guideline
1.2 Background
1.2.1 The Pharmacopoeial Discussion Group (PDG)
1.2.2 The Q4B Expert Working Group (EWG)
1.3 Scope of the Guideline
1.4 General Principles
2. GUIDELINES 
2.1 Q4B Evaluation Process
2.1.1 Step 1
2.1.2 Step 2
2.1.3 Step 3
2.1.4 Step 4
2.1.5 Step 5
2.2 Annex Contents
2.3 Use of the Pharmacopoeial Text
2.3.1 Considerations for Implementation
3. GLOSSARY 
ATTACHMENT I: General Chapters Discussed During ICH Q6A development
ATTACHMENT II: PDG Document Submission Provided For ICH Q4B EWG Evaluation.