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Generative Neural Networks for Addressing the Bioequivalence of Highly Variable Drugs

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Pubblicato in:Algorithms vol. 18, no. 5 (2025), p. 266
Autore principale: Nikolopoulos Anastasios
Altri autori: Karalis, Vangelis D
Pubblicazione:
MDPI AG
Soggetti:
Food & Drug Administration > FDA
Federal regulation
Datasets
Performance evaluation
Generic drugs
Acceptance
Generative adversarial networks
Bioequivalence
Drug development
Pharmaceutical industry
Drugs
Automation
Statistical analysis
Generative artificial intelligence
Patients
Simulation
Gastrointestinal surgery
Data augmentation
Neural networks
Monte Carlo simulation
Decision making
Criteria
Pharmacokinetics
Design
Artificial intelligence
Regulatory agencies
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Abstract:Bioequivalence assessment of highly variable drugs (HVDs) remains a significant challenge, as the application of scaled approaches requires replicate designs, complex statistical analyses, and varies between regulatory authorities (e.g., FDA and EMA). This study introduces the use of artificial intelligence, specifically Wasserstein Generative Adversarial Networks (WGANs), as a novel approach for bioequivalence studies of HVDs. Monte Carlo simulations were conducted to evaluate the performance of WGANs across various variability levels, population sizes, and data augmentation scales (2× and 3×). The generated data were tested for bioequivalence acceptance using both EMA and FDA scaled approaches. The WGAN approach, even applied without scaling, consistently outperformed the scaled EMA/FDA methods by effectively reducing the required sample size. Furthermore, the WGAN approach not only minimizes the sample size needed for bioequivalence studies of HVDs, but also eliminates the need for complex, costly, and time-consuming replicate designs that are prone to high dropout rates. This study demonstrates that using WGANs with 3× data augmentation can achieve bioequivalence acceptance rates exceeding 89% across all FDA and EMA criteria, with 10 out of 18 scenarios reaching 100%, highlighting the WGAN method potential to transform the design and efficiency of bioequivalence studies. This is a foundational step in utilizing WGANs for the bioequivalence assessment of HVDs, highlighting that with clear regulatory criteria, a new era for bioequivalence evaluation can begin.
ISSN:1999-4893
DOI:10.3390/a18050266
Fonte:Engineering Database