Chemistry, manufacturing, and control (CMC) is a crucial stage in drug development. In CMC, activities such as defining product characteristics and modeling manufacturing processes are carried out to ensure the safety, consistency, and efficiency of drug products. In this webinar, we will demonstrate the importance of applying Bayesian statistics to CMC via several case studies.
Case Studies
- Case study 1: Incorporation of uncertainties from multiple sources in manufacturing to provide better control in process consistency and drug safety
- Case study 2: Risk-based approach through probability statements which evaluate equivalency of analytical methods, and assessment of a drug product staying sufficiently within specification throughout its shelf-life
- Case study 3: Using stability data to determine the release windows within which the probability of a drug product meeting specification at the end of its shelf-life is high
