Bioanalysis Zone

Japanese bioanalytical method validation guideline: the world’s first regulatory guideline dedicated to ligand-binding assays


After almost one and a half years of thorough discussion, ‘The Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in Pharmaceutical Development’ was issued on 1 April 2014 from the Ministry of Health, Labour and Welfare (MHLW) of Japan [1]. This Guideline, hereinafter referred to as the ‘MHLW LBA Guideline,’ is the world’s first regulatory guideline solely dedicated to ligand-binding assays (LBA) and became effective on 1 April 2015.

To develop the MHLW LBA Guideline, its supplemental Q&A Document [2] and their English translation [3], the authors have worked in the Study Group of MHLW and its affiliated LBA Working Group, representing the regulatory agency and industries. This manuscript provides an overview of the developing process of the MHLW LBA Guideline and the highlights of key issues.

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