1. WHO Expert Committee on Specifications for Pharmaceutical Preparations N° 992. Annex 7 multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. 2015. Available from: https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/WHO_TRS_992_web.pdf
2. European Agency (EMA) Committee for Human Medicinal Products (CHMP). Guideline on the investigation of bioequivalence Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **. 2010. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf
3. European Agency (EMA) Committee for Human Medicinal Products (CHMP). European Medicines Agency procedural advice for users of the centralised procedure for generic/hybrid applications Doc. Ref. EMEA/CHMP/225411/2006. Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-procedural-advice-users-centralised-procedure-generic/hybrid-applications_en.pdf.
4. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Guidance for Industry Referencing Approved Drug Products in ANDA Submissions. October 2020. Available from: https://www.fda.gov/media/102360/download
5. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Guidance for Industry Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs -General Considerations Draft Guidance. March 2014 Biopharmaceutics. Available from: https://www.fda.gov/files/drugs/published/Bioavailability-and-Bioequivalence-Studies-Submitted-in-NDAs-or-INDs-%E2%80%94-General-Considerations.pdf