1. ISPE Good Practice Guide: Technology Transfer Guide. www.ispe.org/ispe-good-practice-guides
2. US Department of Health and Human Services, US FDA. Guidance for Industry: Bioanalytical Methods Validation. www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf
3. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on Bioanalytical Methods Validation. www.ema.europa.eu/docs/en_GB/document_library/scientific_guideline