The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities
Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently similar to that of its comparator product. The objective of this article is to describe the recommendations from participating Bioequivalence Wor...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-03-01
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| Series: | Journal of Pharmacy & Pharmaceutical Sciences |
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| Online Access: | https://www.frontierspartnerships.org/articles/10.3389/jpps.2024.12398/full |
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| author | Eduardo Agostinho Freitas Fernandes Joy van Oudtshoorn Andrew Tam Liliana Carolina Arévalo González Erwin Guzmán Aurela Henrike Potthast Katalina Mettke Ryosuke Kuribayashi Kohei Shimojo Miho Kasuga Lázaro Morales Zulema Rodríguez Ben Jones Choongyul Ahn Eunju Yun So Hee Kim Clare Rodrigues Toh Tiong Christopher Crane Chantal Walther Matthias S. Roost Tzu-Ling Chen Li-feng Hsu April C. Braddy Alfredo García-Arieta Alfredo García-Arieta Ivana Abalos Milly Divinsky Abdulaziz Alsuwyeh Bader Alzenaidy Adel Alharf |
| author_facet | Eduardo Agostinho Freitas Fernandes Joy van Oudtshoorn Andrew Tam Liliana Carolina Arévalo González Erwin Guzmán Aurela Henrike Potthast Katalina Mettke Ryosuke Kuribayashi Kohei Shimojo Miho Kasuga Lázaro Morales Zulema Rodríguez Ben Jones Choongyul Ahn Eunju Yun So Hee Kim Clare Rodrigues Toh Tiong Christopher Crane Chantal Walther Matthias S. Roost Tzu-Ling Chen Li-feng Hsu April C. Braddy Alfredo García-Arieta Alfredo García-Arieta Ivana Abalos Milly Divinsky Abdulaziz Alsuwyeh Bader Alzenaidy Adel Alharf |
| author_sort | Eduardo Agostinho Freitas Fernandes |
| collection | DOAJ |
| description | Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently similar to that of its comparator product. The objective of this article is to describe the recommendations from participating Bioequivalence Working Group for Generics (BEWGG) members of the International Pharmaceutical Regulators Programme (IPRP) regarding the conduct and acceptance criteria for BE studies of immediate release solid oral dosage forms. A survey was conducted among BEWGG members regarding their BE recommendations and requirements related to study subjects, study design, sample size, single or multiple dose administration, study conditions (fasting or fed), analyte to be measured, selection of product strength, drug content, handling of endogenous substances, BE acceptance criteria, and additional design aspects. All members prefer conducting single dose cross-over designed studies in healthy subjects with a minimum of 12 subjects and utilizing the parent drug data to assess BE. However, differences emerged among the members when the drug’s pharmacokinetics and pharmacodynamics become more complex, such that the study design (e.g., fasting versus fed conditions) and BE acceptance criteria (e.g., highly variable drugs, narrow therapeutic index drugs) may be affected. The survey results and discussions were shared with the ICH M13 Expert Working Group (EWG) and played an important role in identifying and analyzing gaps during the harmonization process. The draft ICH M13A guideline developed by the M13 EWG was endorsed by ICH on 20 December 2022, under Step 2. |
| first_indexed | 2024-04-24T13:57:55Z |
| format | Article |
| id | doaj.art-79b11805c0464d5e943c1517544011d9 |
| institution | Directory Open Access Journal |
| issn | 1482-1826 |
| language | English |
| last_indexed | 2025-03-20T23:27:41Z |
| publishDate | 2024-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Journal of Pharmacy & Pharmaceutical Sciences |
| spelling | doaj.art-79b11805c0464d5e943c1517544011d92024-08-03T14:46:23ZengFrontiers Media S.A.Journal of Pharmacy & Pharmaceutical Sciences1482-18262024-03-012710.3389/jpps.2024.1239812398The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalitiesEduardo Agostinho Freitas Fernandes0Joy van Oudtshoorn1Andrew Tam2Liliana Carolina Arévalo González3Erwin Guzmán Aurela4Henrike Potthast5Katalina Mettke6Ryosuke Kuribayashi7Kohei Shimojo8Miho Kasuga9Lázaro Morales10Zulema Rodríguez11Ben Jones12Choongyul Ahn13Eunju Yun14So Hee Kim15Clare Rodrigues16Toh Tiong17Christopher Crane18Chantal Walther19Matthias S. Roost20Tzu-Ling Chen21Li-feng Hsu22April C. Braddy23Alfredo García-Arieta24Alfredo García-Arieta25Ivana Abalos26Milly Divinsky27Abdulaziz Alsuwyeh28Bader Alzenaidy29Adel Alharf30Agência Nacional de Vigilância Sanitária, Brasília, BrazilSouth African Health Products Regulatory Authority, Pretoria, South AfricaHealth Canada, Ottawa, ON, CanadaInstituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogota, ColombiaInstituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogota, ColombiaFederal Institute for Drugs and Medical Devices, Bonn, GermanyFederal Institute for Drugs and Medical Devices, Bonn, GermanyMinistry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Tokyo, JapanMinistry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Tokyo, JapanMinistry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Tokyo, JapanComisión Federal para la Protección contra Riesgos Sanitarios, Ciudad de Mexico, MéxicoComisión Federal para la Protección contra Riesgos Sanitarios, Ciudad de Mexico, MéxicoMedsafe, Wellington, New ZealandMinistry of Food and Drug Safety, Cheongju-si, Republic of KoreaMinistry of Food and Drug Safety, Cheongju-si, Republic of KoreaMinistry of Food and Drug Safety, Cheongju-si, Republic of Korea0Health Sciences Authority, Singapore, Singapore0Health Sciences Authority, Singapore, Singapore1Therapeutic Goods Administration, Canberra, NSW, Australia2Swissmedic, Bern, Switzerland2Swissmedic, Bern, Switzerland3Taiwan Food and Drug Administration, Taipei, Taiwan4Center for Drug Evaluation, Taipei, Taiwan5Food and Drug Administration, Silver Spring, MD, United States6WHO-Observer, Geneva, Switzerland7Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain8Administración Nacional de Medicamentos, Alimentos y Tecnología, Buenos Aires, Argentina9Center for Pharmaceutical and Enforcement Division, Jerusalem, Israel0Saudi Food and Drug Authority, Riyadh, Saudi Arabia0Saudi Food and Drug Authority, Riyadh, Saudi Arabia0Saudi Food and Drug Authority, Riyadh, Saudi ArabiaBioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently similar to that of its comparator product. The objective of this article is to describe the recommendations from participating Bioequivalence Working Group for Generics (BEWGG) members of the International Pharmaceutical Regulators Programme (IPRP) regarding the conduct and acceptance criteria for BE studies of immediate release solid oral dosage forms. A survey was conducted among BEWGG members regarding their BE recommendations and requirements related to study subjects, study design, sample size, single or multiple dose administration, study conditions (fasting or fed), analyte to be measured, selection of product strength, drug content, handling of endogenous substances, BE acceptance criteria, and additional design aspects. All members prefer conducting single dose cross-over designed studies in healthy subjects with a minimum of 12 subjects and utilizing the parent drug data to assess BE. However, differences emerged among the members when the drug’s pharmacokinetics and pharmacodynamics become more complex, such that the study design (e.g., fasting versus fed conditions) and BE acceptance criteria (e.g., highly variable drugs, narrow therapeutic index drugs) may be affected. The survey results and discussions were shared with the ICH M13 Expert Working Group (EWG) and played an important role in identifying and analyzing gaps during the harmonization process. The draft ICH M13A guideline developed by the M13 EWG was endorsed by ICH on 20 December 2022, under Step 2.https://www.frontierspartnerships.org/articles/10.3389/jpps.2024.12398/fullbioequivalenceIPRPimmediate releasestudy designICH |
| spellingShingle | Eduardo Agostinho Freitas Fernandes Joy van Oudtshoorn Andrew Tam Liliana Carolina Arévalo González Erwin Guzmán Aurela Henrike Potthast Katalina Mettke Ryosuke Kuribayashi Kohei Shimojo Miho Kasuga Lázaro Morales Zulema Rodríguez Ben Jones Choongyul Ahn Eunju Yun So Hee Kim Clare Rodrigues Toh Tiong Christopher Crane Chantal Walther Matthias S. Roost Tzu-Ling Chen Li-feng Hsu April C. Braddy Alfredo García-Arieta Alfredo García-Arieta Ivana Abalos Milly Divinsky Abdulaziz Alsuwyeh Bader Alzenaidy Adel Alharf The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities Journal of Pharmacy & Pharmaceutical Sciences bioequivalence IPRP immediate release study design ICH |
| title | The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities |
| title_full | The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities |
| title_fullStr | The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities |
| title_full_unstemmed | The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities |
| title_short | The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities |
| title_sort | bioequivalence study design recommendations for immediate release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations differences and commonalities |
| topic | bioequivalence IPRP immediate release study design ICH |
| url | https://www.frontierspartnerships.org/articles/10.3389/jpps.2024.12398/full |
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