Bioequivalence Evaluation of Topical Drugs
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Biopharmaceutics".
Deadline for manuscript submissions: 31 October 2026 | Viewed by 261
Editor
Special Issue Information
Dear Colleagues,
The bioequivalence (BE) assessment of topical dermatological products represents a critical regulatory challenge at the intersection of pharmaceutical science, analytical innovation, and computational modeling. Traditional clinical endpoint studies remain costly and time-intensive, prompting a paradigm shift toward alternative methodologies that are more sensitive, reproducible, and scientifically robust. This Special Issue explores cutting-edge approaches transforming topical BE evaluation, including physiologically-based pharmacokinetic (PBPK) modeling for virtual bioequivalence studies, advanced in vitro methodologies (IVPT, IVRT, tape stripping), and novel analytical techniques such as stimulated Raman scattering microscopy and near-infrared spectroscopy.
Recent regulatory frameworks, particularly the European Medicines Agency's modular approach and FDA guidance on IVPT data analysis, emphasize Q1/Q2/Q3 similarity and performance equivalence. Statistical innovations incorporating reference-scaled approaches, mixed-effects models, and Bayesian methodologies address the inherent variability in semi-solid formulations. Furthermore, mechanistic modeling enables prediction of formulation "safe spaces" and assessment of physiological factors (barrier function, vasoconstriction) on BE outcomes.
This collection addresses critical knowledge gaps in batch-to-batch variability, model validation, artificial intelligence applications in dermatopharmacokinetics, and harmonization of global regulatory standards, providing a comprehensive resource for researchers, industry professionals, and regulatory scientists advancing the field of topical drug product development.
Dr. Antonio Monleon-Getino
Guest Editor
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Keywords
- topical bioequivalence
- cutaneous drug delivery
- dermatopharmacokinetics
- IVPT/IVRT methodologies
- PBPK modeling
- virtual bioequivalence
- mechanistic modeling
- artificial intelligence in pharmaceutical analysis
- reference-scaled bioequivalence
- stimulated Raman spectroscopy
- mixed-effects statistical models
- formulation microstructure
- Q1/Q2/Q3 similarity
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