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...