- OECD Principles of Good Laboratory Practices http://www.oecd.org/document/63/0,3343,en_2649_34381_2346175_1_ 1_1_1,00.html
- WHO, Quality Assurance of Pharmaceuticals, Vol 2, Second Edition http://www.who.int/medicines/areas/quality_safety/quality_assurance /production/en/
- ICH Harmonised Guideline: Bioanalytical Method Validation and Study Sample Analysis. M10. Final Version. 24 May 2022.
- ICH Harmonised Guideline: Bioequivalence for Immediate – Release Solid Oral Dosage Forms M13A. Dec2022
- Statistical Approaches to Establishing Bioequivalence. Draft Guidance for Industry. USFDA. Dec, 2022.
