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CMC Drug Development Tips

Phase 1 Drug Substance Characterization

Nexus CMC Advisors
Phase 1 Drug Substance Characterization
Phase 1 Drug Substance Characterization

Phase 1 Drug Substance Characterization

00:42
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FDA readiness and red flags

FDA readiness and red flags

00:54
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Phase 3 package and relation to the NDA submission

Phase 3 package and relation to the NDA submission

00:36
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Phase 2 stability package

Phase 2 stability package

00:31
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Intro to CMC for Peptide Therapeutics
03:29

Intro to CMC for Peptide Therapeutics

IND CMC Information
00:17

IND CMC Information

Phase Appropriate CMC Content
00:16

Phase Appropriate CMC Content

IND Common Pitfalls
00:16

IND Common Pitfalls

Balancing Regulatory Requirements with Flexibility
00:16

Balancing Regulatory Requirements with Flexibility

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