Podcast

Bayesian And ICHQ2 And Q14

Cencora - PharmaLex Talks 12

The ICH-Q2 and ICH-Q14 guidelines collectively outline the development and validation processes for analytical methods used to evaluate medicinal product quality throughout its lifecycle. But what truly defines the quality of a reportable value? This podcast investigates how Bayesian statistics enables the extrapolation of observations made during analytical procedure validation to predict uncertainty surrounding future results, thereby bridging existing gaps in the guidelines.

Speaker Bio: Bruno Boulanger, Ph.D., is Global Head Statistics and Data Science at PharmaLex, where he draws on his many years of experience in several areas of pharmaceutical research and industry including discovery, toxicology, CMC and early clinical phases. Bruno has authored or co-authored more than 100 publications in applied statistics. He organizes and contributes to Non-Clinical Statistics in Europe and, in 2010, set up the First Applied Bayesian Biostatistics conference.

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