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Intro
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Classroom Contents
Antibiotic Bootcamp - How Does a Molecule Become a Physical Medicine to be Given to a Human
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- 1 Intro
- 2 Challenges in CMC
- 3 Kick Off Meeting
- 4 CMC acronyms
- 5 Drug companies
- 6 Phase 3 trials
- 7 Drug requirements
- 8 Evan Hecker
- 9 Dr John OBrien
- 10 CMC Process
- 11 Technical Stagegate Deliverables
- 12 GMP Starting Material
- 13 Supplying the Clinic
- 14 Raw Materials
- 15 Supply the Clinic
- 16 Supporting Clinical Development
- 17 Validation
- 18 Commercial
- 19 Volumetric Efficiency
- 20 Registration Material
- 21 Points to Consider
- 22 Planning
- 23 Timeline
- 24 Changing the Product
- 25 Regulatory CMC
- 26 Bridge the Clinical Program
- 27 Registration Stability Program
