Peranan Uji Ekivalensi In Vitro Dan Ekivalensi In Vivo dalam Penentuan Kualitas Obat

Niken Fitria Yuliar; Fitrianti Darusman; Ratih Aryani

doi:10.29313/bcsp.v3i2.7944

Niken Fitria Yuliar Program Studi Farmasi, Fakultas Matematika dan Ilmu Pengetahuan Alam, Universitas Islam Bandung
Fitrianti Darusman
Ratih Aryani

DOI: https://doi.org/10.29313/bcsp.v3i2.7944

Keywords: Uji Ekivalensi, In vitro, In vivo, Equivalence study

Abstract

Abstract. Drugs are available in the form of innovator and copy drugs. The high cost of innovator drugs makes it difficult for patients to obtain the drugs they need. Therefore, many pharmaceutical industries have developed copy drugs from their innovator drugs. To get a distribution license, the pharmaceutical industry must conduct an equivalence study on copy drugs to ensure that the copy drug has the same efficacy, safety and quality as the innovator drug. However, several surveys show that most patients believe that the effectiveness of copy drugs is not equivalent to the innovator drug. This study aims to determine the role of in vitro equivalence and in vivo equivalence studies in determining drug quality. This study is expected to provide benefits for the public so they are no longer hesitant to use copy drugs. The equivalence study has an important role in ensuring that the quality of the copy drug is equivalent to the innovator drug in terms of efficacy, safety and quality of the copy drug.

Abstrak. Obat tersedia dalam bentuk obat inovator dan obat copy. Tingginya harga obat inovator membuat pasien sulit untuk memperoleh obat yang dibutuhkan. Sehingga banyak industri farmasi yang mengembangkan obat copy dari obat inovatornya. Untuk mendapatkan izin edar, industri farmasi harus melakukan uji ekivalensi terhadap obat copy guna menjamin obat copy memiliki khasiat, keamanan dan mutu yang setara dengan obat inovatornya. Namun, beberapa survei menunjukkan sebagian besar pasien percaya bahwa efektivitas obat copy tidak setara dengan obat inovatornya. Penelitian ini bertujuan untuk mengetahui peranan uji ekivalensi in vitro dan ekivalensi in vivo dalam penentuan kualitas obat. Sehingga penelitian ini diharapkan memberikan manfaat bagi masyarakat agar tidak lagi ragu menggunakan obat copy. Uji ekivalensi memiliki peran penting dalam menjamin kualitas dari obat copy setara dengan obat inovator dalam hal khasiat, keamanan serta mutu obat copy.

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