GMP Publications - Code of Federal Regulation Handbooks by the FDA

ICH Series Handbooks

GMP International Master Reference Guide
ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
ICH E4 - Dose-Response Information to Support Drug Registration
ICH E6(R2) - Good Clinical Practice
ICH E8 - General Considerations for Clinical Trials
ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
ICH Q10 - Pharmaceutical Quality System
ICH Q1A(R2) - Stability Testing of New Drug Substances and Products
ICH Q1E - Evaluation of Stability Data
ICH Q2(R1) - Validation of Analytical Procedures: Text and Methodology
ICH Q5E - Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
ICH Q7, Q8(R2), Q9 and Q10 Combination
ICH Q7, Q8(R2), Q9 and Q10 with FAQ
ICH Q7, Q8, Q9, Q10 and Q11
ICH Q8(R2) - Pharmaceutical Development
ICH Q9 - Quality Risk Management
ICH S2(R1) - Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals
Title 21 CFR Parts 1 - End Nine Volume Set
example: 211, ISBN, Drug, GMP, Etc. - Press Enter
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