Journal Articles related to Clinical Biostatistics

Journal Article
The ICH-Q2 has stated that the objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose, yet it – as well as the ICH-Q14 – fails to clearly define the actual aim of analytical procedure, leading to misunderstanding and confusion. Bruno Boulanger, Ph.D., Global Head Statistics and Data Science at PharmaLex, discusses how Bayesian statistics and interpretation bridge the gaps in the guidelines.
Journal Article
Population pharmacokinetic (PK) models describe the drug concentration-time course in body fluids resulting from administration of a certain drug dose. Compartment models are typically used to conceptualize the mechanisms that take place in the interaction between an organism and a drug product.
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