In Vitro Dissolution and in Silico Modeling Shortcuts in Bioequivalence Testing
Moawia M Al-Tabakha1, Muaed J Alomar2
1Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Ajman University, P.O. Box 346, Ajman, UAE.
Pharmaceutics
|January 18, 2020
Summary
Computer simulation platforms are emerging tools for predicting generic drug performance and supporting biowaiver applications. Further validation of physiologically based pharmacokinetic (PBPK) modeling is needed for reliable bioequivalence (BE) testing and formulation development.
Area of Science:
- Pharmacokinetics and Drug Development
- Computational Modeling in Pharmaceuticals
- In Vitro and In Vivo Correlation
Background:
- In vitro testing and simulation platforms are crucial for predicting the in vivo performance of generic pharmaceutical products.
- These platforms are utilized to provide evidence for biowaiver applications and to support the development of drug formulations.
- Accurate prediction of in vivo performance is essential for efficient drug development and regulatory approval.
Purpose of the Study:
- To review current in vitro testing and simulation platforms used for predicting in vivo performance of generic products.
- To evaluate the utility of these platforms in providing evidence for biowaiver.
- To assess their role in supporting drug formulation development.
Main Methods:
- A comprehensive literature review was conducted using PubMed and Google Scholar databases.
- The search focused on published literature from the past 10 years, using terms like "simulation AND bioequivalence" and "modeling AND bioequivalence".
- Screening and subsequent review of identified research papers were performed.
Main Results:
- Twenty-two research papers were reviewed, highlighting the application of computer simulation software (e.g., GastroPlus™, PK-Sim®, SimCyp®) in drug modeling.
- In silico predictions require careful validation due to the common practice of optimizing models to fit observed data.
- Traditional methods like difference factor (ƒ1) and similarity factor (ƒ2) support biowaiver for certain drug products (BCS classes I and III) but may not be universally applicable to all dissolution profiles.
Conclusions:
- Computer simulation platforms require enhancements in their mechanistic physiologically based pharmacokinetic (PBPK) modeling capabilities.
- Prospective validation of these PBPK models against observed clinical data is necessary.
- Validated simulation platforms hold significant potential as valuable tools for bioequivalence (BE) testing and pharmaceutical formulation development.
Keywords:
bioequivalencebiopharmaceutics classification systembiowaiverdissolutionin silico pharmacokinetic simulationspublication biassimilarity factorMore Related Videos
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