Proposal for risk-based scientific approach on full and partial validation for general changes in bioanalytical method. (5th April 2018)

• Record Type: Journal Article
• Authors: Mochizuki, Ayumi; Ieki, Katsunori; Kamimori, Hiroshi; Nagao, Akemi; Nakai, Keiko; Nakayama, Akira; Nanba, Eitaro
• Is Part Of: Bioanalysis. Volume 10:Number 8(2018)
• Page Start: 577
• Page End: 586
• Publication Date: 2018-04-05
• Subjects: bioanalytical method validation -- LC−MS/MS analysis -- partial validation -- risk-based approach -- small molecules; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2017-0226
• Languages: English
• ISSNs: 1757-6180

Abstract

The guidance and several guidelines on bioanalytical method validation, which were issued by the US FDA, EMA and Ministry of Health, Labour and Welfare, list the 'full' validation parameters; however, none of these provide any details for 'partial' validation. Japan Bioanalysis Forum approved a total of three annual discussion groups from 2012 to 2014. In the discussion groups, members from pharmaceutical companies and contract research organizations discussed the details of partial validation from a risk assessment viewpoint based on surveys focusing on bioanalysis of small molecules using LC−MS/MS in Japan. This manuscript presents perspectives and recommendations for most conceivable changes that can be made to full and partial validations by members of the discussion groups based on their experiences and discussions at the Japan Bioanalysis Forum Symposium.