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“Since 1997, we have been engaging with the accreditation process and the methods validation. The research we had carried out had led us to pick the error calculation model, but it turned out that the person in charge of the calculations was wasting time on...

“Accuracy profile is an approach that has been developed to help to assess the performance of an analytical method and to validate this method. We have participated to the development of this approach and we use it regularly in our laboratories. Furthermore,...

“For our laboratory, the enoval software is the answer to the main problem questioned by iso-17025 and iso-15189 requirements: how to establish uncertainty of measurement of chromatographic techniques used in Toxicology ? Our samples are often complex (blood,...

“As a pharmaceutical analytical development lab we need to have a method validation methodology, which is in accordance with regulatory documents and that uses a statistical evaluation approach relevant to these definitions. To apply validated and easy-to-use...

“The science of statistics in pharmaceutical development is a highly specialized field. Particularly Drug Product Development requires not only comprehensive statistical knowledge, but also out of the box thinking. Combining an academic mindset with industrial...