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Abstract:
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No technological barriers remain to approach with, and execute, Bayesian statistical perspectives, models, and strategies for pharmaceutical manufacturing data evaluation needs, especially multilevel ones. Critical questions to help ensure quality can be readily developed and answered for areas such as, but not only, stability data specifications, product shelf-life, comparability, and analytical methods development. There are cultural transition opportunities from multiple stakeholders within our industry research organization that we are focusing upon to fulfill the potential benefits of “Bayesian-first” solutions in our toolkit. Illustrative examples will be presented on issues including choice of priors, construction of uncertainty intervals, and probabilistic interpretations.
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