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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

Eduardo Agostinho Freitas Fernandes,Joy van Oudtshoorn,Andrew Tam, Liliana Carolina Arevalo Gonzalez,Erwin Guzman Aurela,Henrike Potthast, Katalina Mettke,Ryosuke Kuribayashi,Kohei Shimojo,Miho Kasuga, Lazaro Morales, Zulema Rodriguez,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 Garcia-Arieta,Ivana Abalos,Milly Divinsky, Abdulaziz Alsuwyeh, Bader Alzenaidy,Adel Alharf

Journal of Pharmacy & Pharmaceutical Sciences（2024）

Cited 0|Views9
Key words
bioequivalence,IPRP,immediate release,study design,ICH
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