Expediting early-phase development of small molecules: An integrated approach
Explore the importance of:
- Understanding the scale-up and technology transfer needs at each development phase
- A program roadmap built on a thorough understanding of the molecule’s properties and the impact on formulation choices
- Accommodating changes in manufacturing materials, scale, and process variability associated with technology transfer
- Using integrated CMC capabilities to support drug substance and drug product development and GMP manufacturing from first-in-human (FIH) to Phase III clinical development
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16 February 2023