Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

  1. Matthias S. Roost
  2. Henrike Potthast
  3. Chantal Walther
  4. Alfredo García-Arieta
  5. Ivana Abalos
  6. Eduardo Agostinho Freitas Fernandes
  7. Gustavo Mendes Lima Santos
  8. Zulema Rodríguez Martínez
  9. Andrew Tam
  10. Clare Rodrigues
  11. Diego Alejandro Gutierrez Triana
  12. Erwin Guzmán Aurela
  13. Nayive Rodríguez Rodríguez
  14. Sang Aeh Park
  15. Jayoung Kim
  16. Rami Kariv
  17. Milly Divinsky
  18. Ben Jones
  19. Ryosuke Kuribayashi
  20. Aya Myoenzono
  21. Miho Kasuga
  22. Joy van Oudtshoorn
  23. Jo-Feng Chi
  24. Wen-Yi Hung
  25. Li-Feng Hsu
  26. Christopher Crane
  27. Tony Jarman
  28. April C. Braddy

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1000 Titel
  • Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
1000 Autor/in
  1. Matthias S. Roost |
  2. Henrike Potthast |
  3. Chantal Walther |
  4. Alfredo García-Arieta |
  5. Ivana Abalos |
  6. Eduardo Agostinho Freitas Fernandes |
  7. Gustavo Mendes Lima Santos |
  8. Zulema Rodríguez Martínez |
  9. Andrew Tam |
  10. Clare Rodrigues |
  11. Diego Alejandro Gutierrez Triana |
  12. Erwin Guzmán Aurela |
  13. Nayive Rodríguez Rodríguez |
  14. Sang Aeh Park |
  15. Jayoung Kim |
  16. Rami Kariv |
  17. Milly Divinsky |
  18. Ben Jones |
  19. Ryosuke Kuribayashi |
  20. Aya Myoenzono |
  21. Miho Kasuga |
  22. Joy van Oudtshoorn |
  23. Jo-Feng Chi |
  24. Wen-Yi Hung |
  25. Li-Feng Hsu |
  26. Christopher Crane |
  27. Tony Jarman |
  28. April C. Braddy |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-10-25
1000 Erschienen in
1000 Quellenangabe
  • 24:548-562
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.18433/jpps32260 |
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1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less straightforward for modified release products than for immediate release products. There is consensus that modified release products should demonstrate bioequivalence not only in the fasted state but also in the fed state, but differences exist regarding the necessity of additional multiple dose studies. Fundamental differences between jurisdictions are revealed regarding requirements on the quantitative composition of different strengths and the differentiation of single and multiple unit dosage forms. Differences in terms of in vitro dissolution requirements are obvious, though these are mostly related to possible additional comparative investigations rather than regarding the need for product-specific methods. As with the requirements for immediate release products, harmonization of the various regulations for modified release products is highly desirable to conduct the appropriate studies from a scientific point of view, thus ensuring therapeutic equivalence.
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