The importance of bioequivalence study: focus on clopidogrel  

Oleh:

Setiawati, Arini

Jenis: Article from Journal - ilmiah nasional - terakreditasi DIKTI
Dalam koleksi: Medical Journal of Indonesia vol. 20 no. 02 (May 2011), page 149-153.
Topik: Bioequivalent; Clopidogrel
Fulltext: Volume 20, Issue 2, May 2011 - The importance of bioequivalence study_ focus on clopidogrel.pdf (49.45KB)

Ketersediaan

Perpustakaan FK Nomor Panggil: M35.K Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

Lihat Detail Induk

Isi artikel

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) clopidogrel form 1 that complies with USP 30, 1997 requirements: the R-enantiomer content is not more than 1%. A proof that bioequivalence (BE) means therapeutic equivalence (TE) is also provided for cardiovascular drugs. Clopidogrel has 2 polymorphic forms, form 1 and form 2, which have the same indications. At least one pivotal study of clopidogrel, CAPRIE, used clopidogrel form 1. An atherothrombotic event may be associated with clopidogrel resistance, which occur in about 4 to 30% of patients treated with conventional doses of clopidogrel.

Opini Anda

Klik untuk menuliskan opini Anda tentang koleksi ini!

Kembali