1. International Congress on Harmonization (ICH) Tripartite Guideline. Validation of analytical procedures: text and methodology Q2(R1). 2005. Available from https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf. Accessed 21 June 2023.
2. ICH Harmonized Guideline. Bioanalytical method validation and study sample analysis M10. 2022. Available from https://database.ich.org/sites/default/files/M10_Guideline_Step4_2022_0524.pdf. Accessed 21 June 2023.
3. Food and Drug Administration (FDA) Guidance Document. Bioanalytical method validation guidance for industry. 2018. Available from https://www.fda.gov/media/70858/download. Accessed 21 June 2023.
4. European Medicines Agency. Guidelines for bioanalytical method validation – scientific guideline. 2011. Available from https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-bioanalytical-method-validation_en.pdf. Accessed 21 June 2023.
5. Ministry of Health, Labour and Welfare. Guideline on bioanalytical method (ligand binding assay) validation in pharmaceutical development. 2014. Available from http://www.nihs.go.jp/drug/BMV/260530_LBA-GL_E.pdf. Accessed 21 June 2023.