ReviewPharmaceutical research2023
Current State and Challenges of Physiologically Based Biopharmaceutics Modeling (PBBM) in Oral Drug Product Development.
Review in Pharmaceutical research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
25 citing papers in PubMed.
- Predicting and Confirming Bioequivalence of Alpelisib Oral Granules and Tablets for Patients With PIK3CA-Related Disorders.AAPS PharmSciTech · 2025Trial
- Physiologically Based Pharmacokinetic Modeling for Mechanistic Analysis of Food Effects: A Case Study with Radotinib.Pharmaceutical research · 2026Article
- Physiologically Based Biopharmaceutics Modelling-Best Scientific Practices to Define Drug Product Performance, Latest Regulatory and Industry Perspectives: Workshop Summary Report.Pharmaceutics · 2026Article
- Application of New Approach Methodologies to Improve Oral Biopharmaceutic Assessments.Pharmaceutics · 2026Review
- A Combined Modeling Approach to Predict the Effect of Gastric Emptying Delay on the Pharmacokinetics of Small Molecules.CPT: pharmacometrics & systems pharmacology · 2025Article
- Enhancing the pharmacokinetics of abiraterone acetate through lipid-based formulations: addressing solubility and food effect challenges.Drug delivery and translational research · 2025Article
- Patient-Centric Drug Product Quality Specifications: a Convergence of Clinical and Nonclinical Considerations.The AAPS journal · 2025Article
- Double Peaking Phenomena in Pharmacokinetic Disposition Revisited.Clinical pharmacokinetics · 2025Review
- Metabolic Insights into Drug Absorption: Unveiling Piperine's Transformative Bioenhancing Potential.Pharmaceutical research · 2025Review
- Leveraging Artificial Intelligence for Advancements in Liquid Dosage Formulations in the Pharmaceutical Industry.Therapeutic innovation & regulatory science · 2025Review
- Application of Physiologically Based Biopharmaceutics Modeling (PBBM) to Establish Clinically Relevant Dissolution Specifications for a Prolonged Release Tablet Formulation of Verapamil, a BCS Class I Drug.AAPS PharmSciTech · 2025Article
- Virtual Bioequivalence Assessment of Tofacitinib Once Daily Modified Release Dosage Form in Pediatric Subjects.The AAPS journal · 2025Article
- In Vitro-In Silico Approach in the Development of Clopidogrel Solid Dispersion Formulations.Bioengineering (Basel, Switzerland) · 2025Article
- Physiologically Based Biopharmaceutics Model of Apixaban for Biopharmaceutics Risk Assessment.Pharmaceutics · 2025Article
- Alleviation of Tumor Invasion by the Development of Natural Polymer-based Low-risk Chemotherapeutic Systems - review on the Malignant Carcinoma Treatments.Current drug delivery · 2025Review
- Physiologically based pharmacokinetic modeling of small molecules: How much progress have we made?Drug metabolism and disposition: the biological fate of chemicals · 2025Review
- Establishment of Biopredictive Dissolution and Bioequivalence Safe Space Using the Physiologically Based Biopharmaceutics Modeling for Tacrolimus Extended-Release Capsules.AAPS PharmSciTech · 2024Article
- Article
- Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling.CPT: pharmacometrics & systems pharmacology · 2024Article
- More Than a Gut Feeling─A Combination of Physiologically Driven Dissolution and Pharmacokinetic Modeling as a Tool for Understanding Human Gastric Motility.Molecular pharmaceutics · 2024Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Physiologically based biopharmaceutics modeling (PBBM) emphasizes the integration of physicochemical properties of drug substance and formulation characteristics with system physiological parameters to predict the absorption and pharmacokinetics (PK) of a drug product. PBBM has been successfully utilized in drug development from discovery to postapproval stages and covers a variety of applications. The use of PBBM facilitates drug development and can reduce the number of preclinical and clinical studies. In this review, we summarized the major applications of PBBM, which are classified into six categories: formulation selection and development, biopredictive dissolution method development, biopharmaceutics risk assessment, clinically relevant specification settings, food effect evaluation and pH-dependent drug-drug-interaction risk assessment. The current state of PBBM applications is illustrated with examples from published studies for each category of application. Despite the variety of PBBM applications, there are still many hurdles limiting the use of PBBM in drug development, that are associated with the complexity of gastrointestinal and human physiology, the knowledge gap between the in vitro and the in vivo behavior of drug products, the limitations of model interfaces, and the lack of agreed model validation criteria, among other issues. The challenges and essential considerations related to the use of PBBM are discussed in a question-based format along with the scientific thinking on future research directions. We hope this review can foster open discussions between the pharmaceutical industry and regulatory agencies and encourage collaborative research to fill the gaps, with the ultimate goal to maximize the applications of PBBM in oral drug product development.
Indexed as
Identifiers
36076007What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.