ICH guideline
C19593
concept
An ICH guideline is an internationally harmonized technical standard developed by the International Council for Harmonisation to ensure the quality, safety, and efficacy of pharmaceuticals across different regulatory regions.
Observed surface forms (1)
- clinical trial guideline ×1
Instances (14)
- ICH Q9 Quality Risk Management
- ICH E2A Clinical Safety Data Management
- ICH M4 Common Technical Document
- ICH S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
- ICH Q10 Pharmaceutical Quality System
- ICH Q1 Stability Testing of New Drug Substances and Products
- ICH E8 General Considerations for Clinical Trials
- ICH Q11 Development and Manufacture of Drug Substances
- ICH E2A
- ICH E2C
- ICH CTD
- ICH M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
- ICH S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
- ICH E2D