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Importance of Bio Equivalence Studies

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Submitted By mohammedsoheb
Words 3646
Pages 15
Vol. 20, No. 2, May 2011

Clopidogrel copy products in Indonesia are bioequivalent to Plavix® 149

The importance of bioequivalence study: focus on clopidogrel
Arini Setiawati
Department of Pharmacology & Therapeutics, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia

Abstrak
Studi bioekivalensi (BE) diperlukan untuk menunjukkan apakah suatu produk copy dapat menggantikan produk inovator. Tujuan makalah ini adalah untuk menjelaskan alasan melakukan studi BE, produk-produk utama yang memerlukan studi BE, serta desain dan pelaksanaan studi BE, dengan fokus pada klopidogrel. Semua produk generik klopidogrel di Indonesia telah ditunjukkan bioekivalen (BE) dengan produk inovatornya, Plavix®, dan mereka mengandung bahan baku klopidogrel form 1 yang memenuhi persyaratan USP 30, 1997: kandungan enansiomer R tidak lebih dari 1%. Bukti bahwa bioekivalen (BE) berarti ekivalen secara terapeutik (TE) juga ditunjukkan untuk obat-obat kardiovaskular. Klopidogrel mempunyai 2 bentuk polimorfik, form 1 dan form 2, yang mempunyai indikasi yang sama. Sedikitnya satu studi klopidogrel yang pivotal, CAPRIE, menggunakan klopidogrel form 1. Suatu kejadian aterotrombotik mungkin berhubungan dengan resistensi terhadap klopidogrel, yang terjadi pada sekitar 4 sampai 30% pasien yang diobati dengan dosis klopidogrel yang biasa diberikan. (Med J Indones 2011; 20:149-53)

Abstract
Bioequivalence (BE) study is required to show whether a generic copy product can be interchangeable with the brand innovator product. The aim of this article is to provide the rationale for conducting BE studies, the main products requiring BE studies, the design and conduct of BE studies in general, with focus on clopidogrel. All of the clopidogrel generic products in Indonesia have been shown to be BE to the innovator product Plavix® and they contain API (active pharmaceutical ingredient)

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