Phase 1 Manufacturing: How To Prepare

Phase 1 represents one of the most critical stages of drug development in clinical research because it’s often the first time a drug is tested on human subjects. Despite being smaller in scale, good manufacturing practice (cGMP) requirements must still be followed during Phase 1 to protect the health and safety of trial participants.

This article discusses the lead-up to Phase 1 clinical manufacturing and how drugs are manufactured for clinical research under cGMP.