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Bioequivalence Requirements in Various Global Jurisdictions pp 307–331Cite as

World Health Organisation (WHO)

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Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 28))

Abstract

Much progress has been achieved over the last 50 years in the field of pharmaceuticals, both in terms of introducing new medicines and improving the regulation of medicines. This progress is felt most deeply in highly industrialized countries where citizens can benefit from new innovative drugs and enjoy access to quality assured multisource (generic) medicines as well. Lack of access to quality essential drugs, the majority of which are multisource (generic) medicines, remains a serious health problem and global disequilibrium of quality continues to threaten patients in many parts of the world [1]. The overall tendency is that resource-constrained or resource-poor countries are less likely to control the quality of products on the market, enjoy political support for the regulators, or have properly resourced and functioning regulatory authorities [2]. It is no wonder that in many resource-poor settings patients do not trust locally authorized multisource (generic) products.

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References

  1. Rägo L. Global disequilibrium of quality. In: Prince R, editor. Pharmaceutical quality. Illinois: Davies Health Care International Publishing; 2004. p. 3–21.

    Google Scholar 

  2. Ratanwijitrasin S, Wondemagegnehu E. Effective drug regulation. A multicountry study. Geneva: World Health Organization; 2002. p. 1–142.

    Google Scholar 

  3. Kopp S, Rägo L. The International Pharmacopoeia in the changing environment. Pharm Policy Law. 2007;9:357–68.

    Google Scholar 

  4. WHO Expert Committee on Specifications for Pharmaceutical Preparations: How does it work? Available on the WHO website at http://www.who.int/medicines/services/expertcommittees/pharmprep/ecspp_booklet/en/. Accessed Oct 2015.

  5. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations, Forty-ninth report. Geneva, World Health Organization, 2015 (WHO Technical Report Series, No. 992, Annex 7:134–84).

    Google Scholar 

  6. Ritschel WA. Handbook of basic pharmacokinetics – including clinical applications (by Ritschel WA, Kearns GL, 5th ed.; American Pharmaceutical Association, 1999).

    Google Scholar 

  7. Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations, Forty-ninth report. Geneva, World Health Organization, 2015 (WHO Technical Report Series, No. 992, Annex 8):185–9.

    Google Scholar 

  8. van Faassen F, Vromans H, et al. Biowaivers for oral immediate-release products: implications of linear pharmacokinetics. Clin Pharmacokinet. 2004;43:1117.

    Article  CAS  PubMed  Google Scholar 

  9. Guidelines for good clinical practice for trials on pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations, Twenty-ninth report. Geneva, World Health Organization, 1995 (WHO Technical Report Series, No. 850, p. 97–137).

    Google Scholar 

  10. Additional guidance for organizations performing in vivo bioequivalence studies. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fiftieth Report. Geneva, World Health Organization, 2016 (WHO Technical Report Series, No. 996, Annex 9:305–46.

    Google Scholar 

  11. Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-sixth report. Geneva, World Health Organization, 2002 (WHO Technical Report Series, No. 902, Annex 11:185–9).

    Google Scholar 

  12. WHO Prequalification of Medicines Programme Recommended Comparators. Located on the WHO Prequalification of Medicines Programme website at http://apps.who.int/prequal/info_applicants/info_for_applicants_BE_comparator.htm.

  13. Kis O, Walmsley SL, Bendayan R. In Vitro and In Situ evaluation of pH-dependence of atazanavir intestinal permeability and interactions with acid-reducing agents. Pharm Res. 2014 Sep;31(9):2404–19.

    Article  CAS  PubMed  Google Scholar 

  14. Koskimies P, Katila K, Lammintausta R, Aaltonen AM, Vuorinen J, Saarni O, Scheinin M. Oral bioavailability of ospemifene improves with food intake. Int J Clin Pharmacol Ther. 2013 Oct;51(10):787–94.

    Article  CAS  PubMed  Google Scholar 

  15. Brvar N, Lachance S, Lévesque A, Breznik M, Cvitkovič Marčič L, Merslavič M, Grabnar I, Mateovič-Rojnik T. Comparative bioavailability of two oral formulations of clopidogrel: determination of clopidogrel and its carboxylic acid metabolite (SR26334) under fasting and fed conditions in healthy subjects. Acta Pharma. 2014 Mar;64(1):45–62.

    Article  CAS  Google Scholar 

  16. Kakuda TN, Van De Casteele T, Petrovic R, Neujens M, Salih H, Opsomer M, Hoetelmans RM. Bioequivalence of a darunavir/cobicistat fixed-dose combination tablet versus single agents and food effect in healthy volunteers. Antivir Ther. 2014;19(6):597–606.

    Article  CAS  PubMed  Google Scholar 

  17. Guideline on bioanalytical method validation. European Medicines Agency (EMA), 2011. Available on the EMA website at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf.

  18. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15:657–80.

    Article  CAS  PubMed  Google Scholar 

  19. Westlake WJ. Bioavailability and bioequivalence of pharmaceutical formulations. In: Peace KE, editor. Biopharmaceutical statistics for drug development. New York: Marcel Dekker, Inc.; 1988. p. 329–52.

    Google Scholar 

  20. Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika. 1977;64(2):191–9.

    Article  Google Scholar 

  21. Guidelines for registration of fixed-dose combination medicinal products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-ninth report. Geneva, World Health Organization, 2005 (WHO Technical Report Series, No. 929, Annex 5:94–142).

    Google Scholar 

  22. WHO Model list of essential medicines (2015). World Health Organization (WHO), 2015. Available on the WHO website at http://www.who.int/entity/selection_medicines/committees/expert/20/EML_2015_FINAL_amended_AUG2015.pdf?ua=1.

  23. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, sold oral dosage forms. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fortieth Report. Geneva, World Health Organization, 2006 (WHO Technical Report Series, No. 937, Annex 8:391–439).

    Google Scholar 

  24. Guideline on the investigation of bioequivalence. European Medicines Agency (EMA), 2010. Available on the EMA website at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf.

  25. Becker C, Dressman JB, Amidon GL, Junginger HE, Kopp S, Midha KK, Shah VP, Stavchansky S, Barends DM. Biowaiver monographs for immediate release solid oral dosage forms: isoniazid. J Pharm Sci. 2007;96:522–31.

    Article  CAS  PubMed  Google Scholar 

  26. Soares KC, Rediguieri CF, Souza J, Serra CH, Abrahamsson B, Groot DW, Kopp S, Langguth P, Polli JE, Shah VP, Dressman JB. Biowaiver monographs for immediate- release solid oral dosage forms: Zidovudine (azidothymidine). J Pharm Sci. 2013;102:2409–23.

    Article  CAS  PubMed  Google Scholar 

  27. Cristofoletti R, Nair A, Abrahamsson B, Groot DW, Kopp S, Langguth P, Polli JE, Shah VP, Dressman JB. Biowaiver monographs for immediate- release solid oral dosage forms: Efavirenz. J Pharm Sci. 2013;102:318–29.

    Article  CAS  PubMed  Google Scholar 

  28. Nair A, Abrahamsson B, Barends DM, Groot DW, Kopp S, Polli JE, Shah VP, Dressman JB. Biowaiver monographs for immediate- release solid oral dosage forms: Amodiaquine hydrochloride. J Pharm Sci. 2012;101:4390–401.

    Article  CAS  PubMed  Google Scholar 

  29. Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. United States Food and Drug Administration (FDA), 2000. Available on the FDA website at http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070246.pdf.

  30. Biopharmaceutics Classification System Based Biowaiver. Health Canada, 2014. Available on the Health Canada website at http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/bcs_guide_ld_scb-eng.pdf.

  31. Draft Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. United States Food and Drug Administration (FDA), 2015. Available on the FDA website at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf.

  32. Emami J. In vitro-in vivo correlations: from theory to applications. J Pharm Pharmaceut Sci. 2006;9:169.

    CAS  Google Scholar 

  33. The views stated in this article reflect the views of the authors and not necessarily those of the World Health Organization or of the corresponding regulatory agencies and organizations.

    Google Scholar 

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Author information

Authors and Affiliations

  1. Division of Biopharmaceutics Evaluation 2, 101 Tunney’s Pasture Driveway, Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Canada, Ottawa, ON, K1A 0K9, Canada

    John Gordon

  2. Federal Institute for Drugs and Medical Devices, Kurt-Georg-Kiesinger-Allee 3, DE, 53175, Bonn, Germany

    Henrike Potthast

  3. WHO Prequalification of Medicines Programme; Essential Medicines and Health Products, Health Systems and Innovation, 20, Avenue Appia, 1211, Geneva, 27, Switzerland

    Matthias Stahl

  4. Council for International Organizations of Medical Sciences (CIOMS), 1, Route des Morillons, 1211, Geneva, 2, Switzerland

    Lembit Rägo

Authors
  1. John Gordon
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  2. Henrike Potthast
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  3. Matthias Stahl
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  4. Lembit Rägo
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Corresponding author

Correspondence to Matthias Stahl .

Editor information

Editors and Affiliations

  1. Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa

    Isadore Kanfer

Additional information

The WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.

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© 2017 American Association of Pharmaceutical Scientists

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Gordon, J., Potthast, H., Stahl, M., Rägo, L. (2017). World Health Organisation (WHO). In: Kanfer, I. (eds) Bioequivalence Requirements in Various Global Jurisdictions. AAPS Advances in the Pharmaceutical Sciences Series, vol 28. Springer, Cham. https://doi.org/10.1007/978-3-319-68078-1_11

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