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Dr. Zhang: prespecify key PK calculations and statistical model in protocol
Summary
Dr. Zhang said study protocols are a high-level framework but recommended applicants prespecify how PK parameters such as AUC will be calculated and which statistical model (GLM vs mixed model) will be used.
Dr. Zhang told an online attendee that a study protocol should provide a high-level framework for study design but that applicants will benefit from prespecifying certain technical details. He recommended specifying how to calculate pharmacokinetic (PK) parameters such as area under the curve (AUC) and the statistical approach to be used.
"So it's better to prespecify some level of details such as... how to calculate PK parameters such as AUC and... what's your statistical model and, like, there will be different results between GLM and the mixed model," he said. Dr. Zhang also advised investigating unexpected challenges, ruling out safety issues, and revising protocols early and before statistical analysis if modifications are required.
