A Comprehensive Review of Bioequivalence Studies: Methodologies, Regulatory Considerations, and Future Directions

Liana W. Susanto

doi:10.56951/80v3g940

A Comprehensive Review of Bioequivalence Studies: Methodologies, Regulatory Considerations, and Future Directions

Penulis

Liana W. Susanto Medical Affairs Department, PT Dexa Medica, Jakarta

DOI:

https://doi.org/10.56951/80v3g940

Kata Kunci:

bioekuivalensi, generik, keamanan, efikasi, pengobatan yang dipersonalisasi

Abstrak

Studi bioekuivalensi sangat penting untuk memastikan bahwa formulasi suatu obat generik memenuhi standar keamanan dan efikasi yang telah ditetapkan pada produk inovator. Tinjauan ini mengeksplorasi konsep dasar bioekuivalensi, desain studi yang umum digunakan, serta metodologi statistik terkini yang digunakan untuk evaluasi. Kerangka peraturan dari badan regulasi (contoh: FDA, EMA, dan BPOM-RI) diuraikan, disertai analisis perihal tantangan dalam desain studi dan interpretasinya. Selain itu, perspektif masa depan dalam penelitian bioekuivalensi juga turut dipertimbangkan, terutama seiring dengan semakin berkembangnya sistem penghantaran obat yang kompleks dan pengobatan yang dipersonalisasi. Penelitian berkelanjutan serta pedoman yang terus berkembang akan terus membentuk bidang ilmu farmasi yang krusial ini.

Unduhan

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