Blog & Article
- 18th April 2024
Journal Articles related to Clinical Biostatistics
Journal Article
This article explores how Bayesian statistics make it possible to take observations made during the validation of the analytical procedure and predict the uncertainty around any future result, and in doing so, bridge the gaps that exist in the guidelines.
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.
Journal Article
In this current document, we will try to analyze the effects that a misunderstanding of these concepts may lead to and more specifically the effects on reproducibility.