New Approach Methodologies in Biopharmaceutics: Towards a More Humane Drug Development
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Biopharmaceutics".
Deadline for manuscript submissions: 30 November 2026 | Viewed by 2711
Editors
2. Departamento de Ciencias Farmacéuticas, Facultad de Ciencias, Universidad Católica del Norte, Angamos, Antofagasta 0610, Chile
Interests: bioavailability and bioequivalence; ADMET; QSPR; biopharmaceutics classification system; in vivo-in
2. Department of Bioengineering, Institute of Biomedical Engineering, Imperial College London, Exhibition Road, London SW7 2AZ, UK
3. School of Pharmacy, Faculty of Chemistry and Pharmacy, Pontifical Catholic University of Chile, AV. VICUNA MACKENNA 4860, Santiago 7820436, Chile
Interests: biopharmaceutics; dissolution; permeability; pharmacokinetics; modelling
Interests: biopharmaceutics; drug absorption; modeling; oral dosage forms; pulmonary dosage forms; physical pharmacy
Special Issue Information
Dear Colleagues,
Animal testing has been widely used by the pharmaceutical industry at different stages of drug development. In fact, studies in pre-clinical models are key milestones before advancing into first-in-human trials. The 3Rs principles, replacement, reduction, and refinement, have been proposed to conduct more humane animal research. In recent years, the U.S Food and Drug Administration (FDA) has acknowledged their commitment towards reducing animal testing. This initiative relies not only on the ethical concerns of experimentation in animals, but also on the physiological differences between humans and animal models. In this regard, the development of new approach methodologies (NAMs) has the potential of producing more reliable human models than animals. NAMs include, but may not be limited to, advanced computational models, human organoids and organ-on-a-chip systems.
Biopharmaceutics is the branch of pharmaceutical sciences that study the interaction between physicochemical properties of the drug/formulation and the physiological aspects of the route of administration. Hence, biopharmaceutics can be used to guide the rational development of drug products. Accordingly, the development of physiologically relevant NAMs would be highly attractive to screen promising drug candidates, predict drug absorption, select the route of administration, design enabling formulations and/or assess comparative bioavailability (bioequivalence) between drug products. The embracement of such new technologies would be key to advance towards a more humane drug development process.
With this Special Issue, we aim to provide a platform for exchanging research, innovations, and views, from academia, industry and regulators, on the development of (in vitro and in silico) NAMs for biopharmaceutics purposes. In this Special Issue, original research articles and reviews are welcome. Research areas may include (but not limited to) the following:
- Biorelevant in vitro dissolution;
- In vitro permeability methods;
- Organoids and organ-on-a-chip methods;
- Effect of excipients on drug biorelevant dissolution or permeation;
- Physiologically based biopharmaceutic models;
- Artificial Intelligence-based models;
- Novel devices for biopharmaceutic characterization (e.g., 3D printing).
We look forward to receiving your contributions.
Dr. Miguel Ángel Cabrera-Pérez
Dr. Daniel Hachim
Dr. Mauricio A. García
Guest Editors
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Keywords
- biopharmaceutics
- new approach methodologies
- model and simulations
- organoids
- organ-on-a-chip
- biorelevant in vitro dissolution
- In vitro permeability
- effect of excipients
- biopharmaceutic-oriented drug development
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