دورية أكاديمية
A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme
| العنوان: | A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme |
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| المؤلفون: | Andrew Tam, Alfredo Garcia-Arieta, Ivana Abalos, Eduardo Agostinho Freitas Fernandes, Gustavo Mendes Lima Santos, Zulema Rodriguez Martinez, Milly Divinsky, Rami Kariv, Henrike Potthast, April C. Braddy, Clare Rodrigues, Erwin Guzman Aurela, Liliana Carolina Arevalo Gonzalez, Diego Gutierres Triana, Ben Jones, Choongyul Ahn, Hyuna Kim, So Hee Kim, Ryosuke Kuribayashi, Aya Myoenzono, Kohei Shimojo, Joy van Oudtshoorn, Cornelia Bigler, Ricarda Meincke, Matthias S. Roost, Chantal Walther, Li-feng Hsu, Christopher Crane, Tony Jarman |
| المصدر: | Journal of Pharmacy & Pharmaceutical Sciences, Vol 25 (2022) |
| بيانات النشر: | Frontiers Media S.A., 2022. |
| سنة النشر: | 2022 |
| المجموعة: | LCC:Therapeutics. Pharmacology LCC:Pharmacy and materia medica |
| مصطلحات موضوعية: | Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, RS1-441 |
| الوصف: | The safety and efficacy of a generic product are partly based on demonstrating bioequivalence to the innovator product; however, when the innovator product is no longer available as a comparator product, a survey conducted within the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Programme (IPRP) indicated that the criteria for selecting an alternative comparator product varies. For most members of the BEWGG, an existing marketed generic that was approved based on a comparison with the locally registered innovator product can be used, contingent on criteria that ranges from allowing any generic to be used, to allowing only specific criteria-defined generics to be used. Notwithstanding the acceptability of a generic as an alternative comparator, it is not always the preferred comparator for several jurisdictions. Some jurisdictions require the use of a locally sourced alternative innovator comparator (e.g., the same medicinal ingredient manufactured by a different company) or a foreign innovator comparator. Unlike the other members of the BEWGG, the European Union (EU) has no such options available, rather mechanisms are in place to allow manufacturers to develop a new comparator. The criteria described herein regarding the use of an alternative comparator product can also be applied to scenarios where a specific strength of a series of strengths or an innovative fixed dose combination are discontinued. The results of the survey demonstrate that while criteria for selecting alternative comparator products are not harmonized among the BEWGG participants, the common concern for all jurisdictions is to select a comparator product that meets the safety and efficacy standards of the original innovator product. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 1482-1826 |
| Relation: | https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/33081; https://doaj.org/toc/1482-1826 |
| DOI: | 10.18433/jpps33081 |
| URL الوصول: | https://doaj.org/article/58dad53dc6254587be848657ec85531f |
| رقم الأكسشن: | edsdoj.58dad53dc6254587be848657ec85531f |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 14821826 |
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| DOI: | 10.18433/jpps33081 |