European Medicines Agency guideline on bioanalytical method validation: what more is there to say?
Author:
Affiliation:
1. Department of Bioanalysis, Huntingdon Life Sciences, Woolley Road, Alconbury, Huntingdon, Cambridgeshire, PE28 4HS, UK.
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.12.44
Reference11 articles.
1. EBF and EUFEPS Workshop on: EMEA Draft Guideline on Validation of Bioanalytical Methods. Brussels, Belgium, 15–16 April 2010.
2. AmsterdamPV. How to implement the EMA Guideline on bioanalytical method validation. Presented at:EBF 4th Open Symposium. Barcelona, Spain, 16–18 November 2011.
3. Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
4. Determination of carryover and contamination for mass spectrometry-based chromatographic assays
5. Assessing the matrix effects of hemolyzed samples in bioanalysis
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