ReviewMolecular pharmaceutics2024
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.
Review in Molecular pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 1 synthesis or guideline pooled it.
- In Silico Clinical Trials in Drug Development: A Systematic Review.Therapeutic innovation & regulatory science · 2026Pooled it
- Narrow Therapeutic Index Drugs: Regulatory Frameworks, Bioequivalence, and Model-Informed Precision Dosing.Pharmaceutics · 2026Review
- Sex-Related Differences in Physiologically-Based Biopharmaceutics Modeling.CPT: pharmacometrics & systems pharmacology · 2026Article
- Is a Clinical Trial With a Non-Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK.Clinical pharmacology and therapeutics · 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
- Biopharmaceutic Assessment of Post-Approval Changes for Azithromycin Immediate Release Tablets Using Predictive In Vitro Dissolution and a Model-Informed Approach.Pharmaceutical research · 2026Article
- Utility of Modeling and Simulations in Drug Development: Contrasting Japan, US and UK Descriptions of PBPK Modeling from Package Inserts.The AAPS journal · 2026Article
- Leveraging Model Integrated Bioequivalence (MIBE) to Address Regulatory Concerns and Waive Repeat Bioequivalence Studies-A Case Study with Clopidogrel.Journal of clinical pharmacology · 2026Article
- DoE- and PBBM-Driven Formulation Development of an Extended-Release Donepezil Tablet.Pharmaceuticals (Basel, Switzerland) · 2025Article
- The Evolving Role of In Vitro-In Vivo Correlation in Model-Informed Drug Development: A Multi-Stakeholder Perspective.CPT: pharmacometrics & systems pharmacology · 2025Article
- An Open-Source Framework for Virtual Bioequivalence Modeling and Clinical Trial Design.CPT: pharmacometrics & systems pharmacology · 2025Article
- A Combined Modeling Approach to Predict the Effect of Gastric Emptying Delay on the Pharmacokinetics of Small Molecules.CPT: pharmacometrics & systems pharmacology · 2025Article
- Virtual Bioequivalence Assessment and Dissolution Safe Space Exploration for Fixed-Dose Metformin-Glyburide Tablet Using Physiologically Based Biopharmaceutics Modeling.Pharmaceutics · 2025Article
- Physiologically Based Pharmacokinetic Modeling of Efavirenz Nanoparticles: from Animal Model to Human Extrapolation.ACS omega · 2025Article
- Canine Mdr1 Knockout MDCK Cells Reliably Estimate Human Small Intestinal Permeability (Molecular pharmaceutics · 2025Article
- Development of a Universal In Vivo Predictive Dissolution Method for a Borderline BCS III/IV Drug Guided by Modeling and Simulations─Acyclovir as a Case Study.Molecular pharmaceutics · 2025Article
- Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions.Molecular pharmaceutics · 2025Review
- Surge DosePharmaceutics · 2025Article
- Paving the Path for Increased Technological Innovation, Strategic Decision Making and Regulatory Acceptance of Modeling and Simulation Approaches.Pharmaceutical research · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
Abstract
Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological, and pharmaceutical data to simulate and predict drug behavior in vivo. Effective utilization of PBBM requires a consistent approach to model development, verification, validation, and application. Currently, only one country has a draft guidance document for PBBM, whereas other major regulatory authorities have had limited experience with the review of PBBM. To address this gap, industry submitted confidential PBBM case studies to be reviewed by the regulatory agencies; software companies committed to training. PBBM cases were independently and collaboratively discussed by regulators, and academic colleagues participated in some of the discussions. Successful bioequivalence "safe space" industry case examples are also presented. Overall, six regulatory agencies were involved in the case study exercises, including ANVISA, FDA, Health Canada, MHRA, PMDA, and EMA (experts from Belgium, Germany, Norway, Portugal, Spain, and Sweden), and we believe this is the first time such a collaboration has taken place. The outcomes were presented at this workshop, together with a participant survey on the utility and experience with PBBM submissions, to discuss the best scientific practices for developing, validating, and applying PBBMs. The PBBM case studies enabled industry to receive constructive feedback from global regulators and highlighted clear direction for future PBBM submissions for regulatory consideration.
Indexed as
Identifiers
What 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.