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.

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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.
Authors: Fernandes EAF; Agência Nacional de Vigilância Sanitária, Brasília, Brazil., van Oudtshoorn J; South African Health Products Regulatory Authority, Pretoria, South Africa., Tam A; Health Canada, Ottawa, ON, Canada., González LCA; Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogota, Colombia., Aurela EG; Instituto Nacional de Vigilancia de Medicamentos y Alimentos, Bogota, Colombia., Potthast H; Federal Institute for Drugs and Medical Devices, Bonn, Germany., Mettke K; Federal Institute for Drugs and Medical Devices, Bonn, Germany., Kuribayashi R; Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Shimojo K; Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Kasuga M; Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Morales L; Comisión Federal para la Protección contra Riesgos Sanitarios, Ciudad de Mexico, México., Rodríguez Z; Comisión Federal para la Protección contra Riesgos Sanitarios, Ciudad de Mexico, México., Jones B; Medsafe, Wellington, New Zealand., Ahn C; Ministry of Food and Drug Safety, Cheongju-si, Republic of Korea., Yun E; Ministry of Food and Drug Safety, Cheongju-si, Republic of Korea., Kim SH; Ministry of Food and Drug Safety, Cheongju-si, Republic of Korea., Rodrigues C; Health Sciences Authority, Singapore, Singapore., Tiong T; Health Sciences Authority, Singapore, Singapore., Crane C; Therapeutic Goods Administration, Canberra, NSW, Australia., Walther C; Swissmedic, Bern, Switzerland., Roost MS; Swissmedic, Bern, Switzerland., Chen TL; Taiwan Food and Drug Administration, Taipei, Taiwan., Hsu LF; Center for Drug Evaluation, Taipei, Taiwan., Braddy AC; Food and Drug Administration, Silver Spring, MD, United States., García-Arieta A; WHO-Observer, Geneva, Switzerland.; Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain., Abalos I; Administración Nacional de Medicamentos, Alimentos y Tecnología, Buenos Aires, Argentina., Divinsky M; Center for Pharmaceutical and Enforcement Division, Jerusalem, Israel., Alsuwyeh A; Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Alzenaidy B; Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Alharf A; Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Source: Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques [J Pharm Pharm Sci] 2024 Mar 21; Vol. 27, pp. 12398. Date of Electronic Publication: 2024 Mar 21 (Print Publication: 2024).
Publication Type: Journal Article; Review
Journal Info: Publisher: Frontiers Media S. A Country of Publication: Switzerland NLM ID: 9807281 Publication Model: eCollection Cited Medium: Internet ISSN: 1482-1826 (Electronic) Linking ISSN: 14821826 NLM ISO Abbreviation: J Pharm Pharm Sci Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1482-1826
DOI:10.3389/jpps.2024.12398