Philippe Hubert

TL;DR: Suggestions presented in this paper should help the analyst to design and perform the minimum number validation experiments needed to obtain all the required information to establish and demonstrate the reliability of its analytical procedure.

TL;DR: The SFSTP guide as discussed by the authors suggests a validation strategy in two steps: a pre-validation and the validation itself, which is the result of a consensus between professionals having expertise in bioanalytical and/or statistical fields.

TL;DR: The main purpose of this paper is to outline the inconsistencies between some definitions of the criteria and the experimental procedures proposed to evaluate those criteria in recent documents dedicated to the validation of analytical methods in the pharmaceutical field.

TL;DR: A simple and accurate HPLC/DAD method was developed for the quantification of major neutral and acidic cannabinoids present in cannabis plant material and was validated following an approach using accuracy profiles based on beta-expectation tolerance intervals for the total error measurement, and assessing the measurements uncertainty.

TL;DR: This article aims to explain what an analytical method DS is, why it is useful for the robust development and optimization of analytical methods and how to build such a DS.