Recommendations from the European Bioanalysis Forum on method establishment for tissue homogenates

Author:

Timmerman Philip1,Mokrzycki Nathalie2,Delrat Pascal3,Meulder Marc De1,Erbach Eva4,Lentheric Irene5,McIntosh Morna6,Dzygiel Pawel7

Affiliation:

1. Janssen Research & Development, a division of Janssen Pharmaceutica N.V. Turnhoutseweg 30, 2340 Beerse, Belgium

2. Laboratoires Merck Sharp & Dohme-Chibret, Route de Marsat, Riom, 63963 Clermont-Ferrand Cedex 9, France

3. Technologie SERVIER, 25/27 rue Vignat, 45000 Orléans, France

4. Bayer Pharma AG Global Drug Discovery, Global Early Development, Drug Metabolism & Pharmacokinetics Müllerstr. 178, Gebäude S109, Raum 220A 13353 Berlin, Germany

5. Harlan Laboratories S.A. Argenters, 6 08130 Santa Perpetua de Mogoda Barcelona, Spain

6. Charles River laboratories, Bioanalysis & Immunology, Charles River Tranent, Edinburgh, EH33 1NE

7. Hoffman-La Roche AG, Grenzacherstrasse 124CH-4070 Basel Switzerland

Abstract

Tissue analysis has always been a difficult discipline of bioanalysis. Differences in scientific approaches or level of adherence to regulated guidelines have led to a growing ambiguity on how to perform tissue analysis, an ambiguity that starts with the question of if we analyze tissue or tissue homogenates. The European Bioanalysis Forum (EBF) is proposing a recommendation on how to perform method establishment and analysis of tissue homogenates. The recommendation is based on broad discussions and survey data from the EBF community and, as for many EBF recommendations, focuses on finding the right balance between science, technology and regulations.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference11 articles.

1. Bioanalysis of drug in tissue: current status and challenges

2. Tissue analysis – a powerful tool for drug discovery and development

3. A primer for best practices in tissue preparation for bioanalysis

4. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM). Guidance for Industry. Bioanalytical Method Validation. Center for Drug Evaluation and Research (CDER), Rockville, MD, USA (2001). www.fda.gov/downloads/Drugs/Guidances/ucm070107.pdf 

5. EMA. Guideline on bioanalytical method validation. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf

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