Physiologically-Based Pharmacokinetics (PBPK) and Biopharmaceutics (PBBM) Modeling for Formulation Development
A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Pharmacokinetics and Pharmacodynamics".
Deadline for manuscript submissions: 31 May 2024 | Viewed by 1437
Special Issue Editors
Interests: solid oral dosage forms; dissolution; modeling & simulation; PBPK; PBBM; dissolution/bioequivalence safe space
Interests: preformulation; formulation; solid oral dosage forms; multiparticulate systems; dissolution; design of experiments; PBBM; dissolution/bioequivalence safe space
Special Issue Information
Dear Colleagues,
Physiologically-Based Pharmacokinetics (PBPK) modeling represents advancements in mathematical models based on information from animal and human physiology that can be integrated with the physicochemical information of a drug to predict its concentration in any tissue. Physiologically-Based Biopharmaceutics (PBBM) modeling establishes a link between the performance of a formulation, such as in vitro drug dissolution, and a PBPK model. In this context, PBPK and PBBM approaches are of great interest to pharmaceutical companies for various applications, particularly in the development of formulations with desirable drug release, the evaluation of the bio-predictive and clinical relevance of dissolution methods, support for formulation changes, assessment of the impact on bioequivalence (BE) due to any formulation modifications, and to run virtual BE studies. PBPK and PBBM can also be employed for predicting drug disposition from other routes of administration, such as injectable, nasal–pulmonary, dermal, transdermal, ocular, and buccal.
This Special Issue aims to gather recent advances in the use of PBBK and PBBM for formulation development, encompassing all aspects that can contribute to supporting drug product development. We are pleased to invite you to submit original research articles or reviews utilizing PBPK and/or PBBM for drug product development (across all dosage forms). Topics of interest may include, but are not limited to, biopharmaceutics applications, the evaluation of dissolution methods, regulatory applications, post-approval changes, virtual bioequivalence studies, and in vitro–in vivo correlation.
We look forward to receiving your contributions.
Dr. Marcelo Dutra Duque
Dr. Michele Georges Issa
Dr. Humberto Gomes Ferraz
Guest Editors
Manuscript Submission Information
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Keywords
- PBPK
- PBBM
- formulation development
- dissolution
- IVIVC
- IVIVR
- particle size distribution
- bioequivalence
- virtual bioequivalence
- drug release