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INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016 open access , Peer-reviewed, and Refereed Journals, Impact factor 8.15 |
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| Paper Title: | Review Article on Regulatory Requirements for Conducting Bioequivalence/Bioavailability Studies in USA, Europe, Canada and India. |
| Authors Name: | Aamod Autade , Vaishali Patil |
| Unique Id: | IJSDR2306232 |
| Published In: | Volume 8 Issue 6, June-2023 |
| Abstract: | This article highlights the regulatory requirements for conducting bioavailability/bioequivalence (BA/BE) studies, which aim to ensure therapeutic equivalence between a test drug and a generic or reference drug. The study review emphasizes adherence to standards of quality, efficacy, and safety comparable to the innovator’s product. While international harmonization of regulatory requirements for bioequivalence are lacking, there are partial harmonization in the bioequivalence range and statistical analysis. However, discrepancies exist in the subject selection, study design for immediate release and modified release formulations, food effect assessment, application of multiple-dose studies, in-vitro dissolution study and retention of innovator and reference products. This review offers a concise overview of the relevant regulatory guidelines for bioequivalence studies in the United States, Europe, Canada, and India including a comparative analysis of differences in study design and specifications. Importantly, the conduction of BA/BE studies in these countries aligns with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidance. |
| Keywords: | Bioequivalence, BA/BE studies, Steady-state, Single-dose, Multiple-dose, EMA, USFDA, CDSCO, Health Canada, ICH GCP. |
| Cite Article: | "Review Article on Regulatory Requirements for Conducting Bioequivalence/Bioavailability Studies in USA, Europe, Canada and India.", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.8, Issue 6, page no.1723 - 1734, June-2023, Available :http://www.ijsdr.org/papers/IJSDR2306232.pdf |
| Downloads: | 000337351 |
| Publication Details: | Published Paper ID: IJSDR2306232 Registration ID:207429 Published In: Volume 8 Issue 6, June-2023 DOI (Digital Object Identifier): http://doi.one/10.1729/Journal.35159 Page No: 1723 - 1734 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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