ICH Q11 Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers
Title:
ICH Q11 Guideline: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
Questions and Answers
Short Title:
Q11 Q&As
Origin/Publisher:
Document Type:
ICH document
Content:
This document provides clarification to improve harmonisation of the considerations for the selection and justification of starting materials for API syntheses.