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

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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Bibliographic Details
Main Authors: 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, Ivana Abalos, Milly Divinsky, Abdulaziz Alsuwyeh, Bader Alzenaidy, Adel Alharf
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-03-01
Series:Journal of Pharmacy & Pharmaceutical Sciences
Subjects:
bioequivalence
IPRP
immediate release
study design
ICH
Online Access:https://www.frontierspartnerships.org/articles/10.3389/jpps.2024.12398/full

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https://www.frontierspartnerships.org/articles/10.3389/jpps.2024.12398/full

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