Is the bioanalytical community ready to revise the use of certain validation concepts and nomenclature?
Author:
Affiliation:
1. Regulatory Bioanalysis, AstraZeneca R&D Möndal, SE-431 89 Mölndal, Sweden.
2. Regulatory Bioanalysis, AstraZeneca R&D Möndal, SE-431 89 Mölndal, Sweden
3. Regulatory Bioanalysis, AstraZeneca R&D Alderley, Cheshire, 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.12.176
Reference10 articles.
1. European Medicines Agency guideline on bioanalytical method validation: what more is there to say?
2. The use of human plasma as matrix for calibration standards in pre-clinical LC–MS/MS methods—A way to reduce animal use
3. Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
4. Best practices in a tiered approach to metabolite quantification: views and recommendations of the European Bioanalysis Forum
5. Simultaneous determination of a p38 MAP kinase inhibitor and its amide hydrolyzed metabolite in Cynomolgus monkey plasma by LC–MS/MS, and its application to a toxicokinetic study
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1. A community of practice approach to bioanalysis delivery: the role of the Preclinical Bioanalysis and Toxicokinetics department at AstraZeneca;Bioanalysis;2014-05
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