VIRTUAL BIOEQUIVALENCE APPLICATIONS IN DRUGS

Yıl 2024, Cilt: 48 Sayı: 3, 1163 - 1179, 10.09.2024

Tuğba Gülsün , Huriye Demir , Levent Öner

https://doi.org/10.33483/jfpau.1456868

Öz

Objective: Virtual bioequivalence studies play a critical role in facilitating and optimizing drug development processes of new drugs and generic drugs. This approach relies on mathematical calculations to mimic and predict the behavior of drugs in the human body. Virtual bioequivalence studies can assess the pharmacokinetic and clinical performance between test and reference formulations by utilizing in vitro, in silico and in vivo data. This enables the prediction of drug effects and optimization of dosage.
Result and Discussion: The regulatory position of virtual bioequivalence studies has not yet been fully determined, making collaboration among regulatory authorities, the pharmaceutical industry, universities, and research institutions crucial. Particularly for drugs administered orally or through other systemic routes, determining the framework of physiologically-based pharmacokinetic and biopharmaceutical modeling studies through virtual bioequivalence is important to support exemptions and optimization from in vivo clinical trials. Virtual bioequivalence studies can be a significant tool in improving drug development processes, reducing time, and cutting costs. However, continued progress in this field and further integration of these methods into drug-related regulatory processes are necessary.

Anahtar Kelimeler

Artificial intelligence, biowaiver, physiologically based pharmacokinetic modeling, in silico, safe space, simulation, virtual bioequivalence

İLAÇLARDA SANAL BİYOEŞDEĞERLİK UYGULAMALARI

Öz

Amaç: Sanal biyoeşdeğerlik çalışmaları hem yeni ilaçların hem de jenerik ilaçların geliştirme süreçlerini kolaylaştırma ve optimize etmede kritik rol oynamaktadır. Bu yaklaşım, ilaçların insan vücudundaki davranışlarını taklit etmek ve kestirebilmek için matematiksel hesaplamalara dayanmaktadır. Sanal biyoeşdeğerlik çalışmaları ile in vitro, in siliko ve in vivo veriler kullanılarak, test ve referans formülasyonlar arasındaki farmakokinetik ve klinik performans değerlendirebilir. Bu modeller, ilaçların vücutta nasıl dağıldığını, metabolize olduğunu ve atıldığını daha duyarlı bir şekilde tahmin edebilir. Bu sayede ilaçların etkilerinin kestirilebilmesi ve dozun optimize edilmesine olanak sağlar.
Sonuç ve Tartışma: Sanal biyoeşdeğerlik çalışmalarının yasal düzenlemelerdeki yeri henüz tam olarak belirlenememiştir, bu nedenle ilaçla ilgili yasal otoriteler, ilaç endüstrisi, üniversiteler ve araştırma kuruluşlarının iş birliği yapması oldukça önemlidir. Özellikle ağız yolu ve diğer uygulama yolları ile kullanılan sistemik etki gösteren ilaçların, fizyolojik temelli farmakokinetik ve biyofarmasötik modelleme çalışmalarının çerçevesinin belirlenmesi, in vivo klinik çalışmalardan muafiyetin ve optimizasyonunun desteklenmesi için sanal biyoeşdeğerlik çalışmaları önemlidir. Sanal biyoeşdeğerlik çalışmaları, ilaç geliştirme süreçlerini iyileştirmek, süreyi kısaltmak ve maliyetleri düşürmek için önemli bir araç olabilir, ancak bu alandaki ilerlemelerin devam etmesi ve bu yöntemlerin ilaçla ilgili yasal düzenleme süreçlerine daha fazla entegre edilmesi gerekmektedir.

Anahtar Kelimeler

Biyomuafiyet, fizyolojik temelli farmakokinetik modelleme, güvenli alan, in siliko, sanal biyoeşdeğerlik, simülasyon, yapay zekâ

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