Leon Doneski

Leon Doneski has over 20 years of experience in the pharmaceutical industry, contributing to many product registrations. He is currently the Director of Regulatory CMC for Arcutis Biotherapeutics. Leon earned his PhD in analytical chemistry from the University of Delaware.

Articles

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Current Good Manufacturing Practice (cGMP): An Overview for Analytical Chemists

Leon Doneski;Michael W. Dong

December 1st 2023

This article provides a high-level overview of Current Good Manufacturing Practice (cGMP) regulations and related public quality standards.

Woman scientist, documents and hands writing vaccine review, planning test and healthcare checklist. Science, paperwork report and laboratory research for investigation, results or chemistry analysis | Image Credit: © Azee Jacobs/peopleimages.com - stock.adobe.com

Current Good Manufacturing Practice (cGMP): An Overview for the Analytical Chemist

Leon Doneski;Michael W. Dong

November 1st 2023

We provide a high-level overview of Current Good Manufacturing Practice (cGMP) regulations and their impact on the analytical chemist in the pharmaceutical industry.

Young female medic in uniform working with microscope making analysis at the laboratory office | Image Credit: © rh2010 - stock.adobe.com

Good Laboratory Practice (GLP): An Overview for the Analytical Chemist

Leon Doneski;David Roos;Michael W. Dong

October 1st 2023

GLP helps ensure the quality of different studies during drug development. Here, the authors outline practices relevant to analytical and bioanalytical chemists.

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Good Laboratory Practice: An Overview for the Analytical Chemist

Leon Doneski;David Roos;Michael W. Dong

October 1st 2023

An overview of GLP regulations and related public standards.

Factory of the pharmaceutical industry. Pills on the conveyor | Image Credit: © Mike Mareen - stock.adobe.com

Pharmaceutical Regulations: An Overview for the Analytical Chemist

Leon Doneski;Michael W. Dong

June 2nd 2023

What you need to know about pharmaceutical regulations as an analytical chemist is provided here, including an explanation about how working in a Good Manufacturing Practice (GMP) environment can yield positive results.