Guidance on CMC for Phase 1 and Phases 2/3 Investigational ...

May 18, 2011 · Phase 2 Safety updates on the information provided for Phase 1 More detailed description of the configuration and chemical structure for complex organic compounds Phase 3 Drug Substance Data for Phases 2 & 3 Complete description of the physical, chemical and biological characteristics and supporting evidence to elucidate and

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