Incurred sample reproducibility: 10 years of experiences: views and recommendations from the European Bioanalysis Forum-Reference-Cited by-同舟云学术

Incurred sample reproducibility: 10 years of experiences: views and recommendations from the European Bioanalysis Forum

Published:2018-11-01 Issue:21 Volume:10 Page:1723-1732
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Kall Morten Anders¹,Michi Marco²,van der Strate Barry³,Freisleben Achim⁴,Stoellner Daniela⁵,Timmerman Philip⁶

Affiliation:

1. H Lundbeck A/S, Copenhagen, Denmark

2. Aptuit an Evotec company, Verona, Italy

3. PRA Health Sciences, Assen, The Netherlands

4. Nuvisan GmbH, Grafing, Germany

5. Novartis Institutes for BioMedical Research, Basel, Switzerland

6. European Bioanalysis Forum, Brussels, Belgium

Abstract

With 10 years of experiences on incurred sample reanalysis (ISR) as an integrated part of regulated bioanalysis, the European Bioanalysis Forum has reflected on the implementation and the use of ISR. Three surveys were conducted in 2016 and 2017 as a revisit of the ISR experiences within European pharmaceutical industry and contract research organizations: has ISR become a tool for postvalidation and process check of a bioanalytical method performance and has ISR become a routine in our laboratories? Do we agree on the interpretation of guidelines/guidance and are we aligned in our approach – among others?

Publisher

Future Science Ltd

Subject

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

Link

http://www.future-science.com/doi/pdf/10.4155/bio-2018-0194

Reference12 articles.

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3. Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum

4. 2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop

5. EMA, European Medicines Agency. Guideline on bioanalytical method validation. EMEA/CHMP/EWP/192217/2009 (2011). https://www.ema.europa.eu/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf.

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