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Session 4: CMC Requirements for an Investigational New Drug
Session Chair(s)
Priya Jambhekar
President
PBS Regulatroy Consulting Group, United States
Part A: Drug Substance
- Part A of the IND will discuss in detail how to design the Drug Substance portion of an IND with real examples
- Part B of the IND will discuss in detail how to design the Drug Product portion of an IND with real examples
- Part C of the IND will discuss in detail how to design the Placebo portion of an IND in the event placebos are used in clinical trials