Complete ICH Guidance Document Bundle

This comprehensive resource bundles 32 ICH guidances on pharmaceuticals and biologics: 11 on Quality, 10 each on Safety and Efficacy, and M3 on nonclinical safety studies.

This bundle includes:

• Q1 Stability Testing
• Q2 Analytical Validation
• Q3 Impurities
• Q4 Pharmacopeias
• Q5A–Q5E Quality of Biotechnological Products
• Q6 Specifications
• Q7 Good Manufacturing Practice
• Q8 Pharmaceutical Development
• Q9 Quality Risk Management
• Q10 Pharmaceutical Quality System
• Q11 Development and Manufacture of drug substances—chemical and biotechnological/biological entities
• S1 Carcinogenicity Studies
• S2 Genotoxicity
• S3 Toxicokenetics and Pharmacokinetics
• S4 Toxicity Testing
• S5 Reproductive Toxicology
• S6 Biotechnological Products
• S7 Pharmacology Studies
• S8 Immunotoxicology Studies
• S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
• S10 Photosafety Evaluation
• E1, E2 Clinical Safety
• E3 Clinical Study Reports
• E4 Dose-Response Studies
• E5 Ethnic Factors
• E6 Good Clinical Practice
• E7, E8, E9, E10, E11 Clinical Trials
• E12 Guidelines for Clinical Evaluation by Therapeutic Category
• E14 Clinical Evaluation
• E15 Pharmacogenomics
• E16 Biomarkers
• M3 Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals