ArticleMolecular pharmaceutics2025
Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report.
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Article in Molecular pharmaceutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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19citing papers in PubMed
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Who cites it
19 citing papers in PubMed.
- Predicting and Confirming Bioequivalence of Alpelisib Oral Granules and Tablets for Patients With PIK3CA-Related Disorders.AAPS PharmSciTech · 2025Trial
- Virtual bioequivalence-guided PBBM prediction for ibuprofen/diphenhydramine citrate tablets: impact of dissolution variability and clinical standard development.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026Article
- Solid nano-lipoidal intelligent premix (SNIP): designing, optimization, and characterization.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 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
- Guiding the Molnupiravir Tablet Formulation Using Physiologically Based Biopharmaceutics Modeling and Successfully Establishing Dissolution Safe Space.The AAPS journal · 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
- Model-Integrated Bioequivalence (MIBE) in Generic Drug Research: Can We Ease the Bioequivalence Burden?Pharmaceutics · 2026Review
- PQRI Workshop: Model-Informed Drug Development (MIDD) Approaches in Pediatric Formulation Development.The AAPS journal · 2026Article
- Biopharmaceutic Assessment of Post-Approval Changes for Azithromycin Immediate Release Tablets Using Predictive In Vitro Dissolution and a Model-Informed Approach.Pharmaceutical research · 2026Article
- Utilizing Physiologically Based Pharmacokinetic Modeling and Virtual Simulation for Simvastatin Tablets to Evaluate the Sensitivity of Using Parent vs Metabolite as Analyte on Bioequivalence Assessment.The AAPS journal · 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
- Virtual Bioequivalence Assessment and Dissolution Safe Space Exploration for Fixed-Dose Metformin-Glyburide Tablet Using Physiologically Based Biopharmaceutics Modeling.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
- Commentary and Review on Prospective Prediction of Bioequivalence of Oral Dosage Forms using Compendial Dissolution Testing and PBPK Modeling.The AAPS journal · 2025Review
- Using Model Master Files to Support Oral Drug Product Development and Regulatory Submissions.Pharmaceutical research · 2025Article
- Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization.Pharmaceutical research · 2025Article
- Physiologically-Based Biopharmaceutics Modeling for Ibuprofen: Identifying Key Formulation Parameter and Virtual Bioequivalence Assessment.Pharmaceutics · 2025Article
Corrections and comments
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Authors and funding
33 authors.
Christer TannergrenBiopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 43183, Sweden.ORCID 0000-0003-3897-337X
Sumit AroraJanssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.ORCID 0000-0001-8860-667X
Andrew BabiskinDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States.
Luiza BorgesBrazilian Health Regulatory Agency (ANVISA), SIA Trecho 5 - Guará, Brasília, Distrito Federal 71205-050, Brazil.ORCID 0000-0001-8634-221X
Parnali ChatterjeeOffice of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.
Yi-Hsien ChengDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States.
André DallmannBayer HealthCare SAS, Lille, France, on behalf of Pharmacometrics/Modeling & Simulation, Research & Development, Pharmaceuticals, Bayer AG, Leverkusen 51368, Germany.ORCID 0000-0003-1108-5719
Anitha GovadaOffice of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.
Tycho HeimbachPharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States.ORCID 0000-0003-1224-0629
Martin HingleTechnical Research and Development, Novartis Pharma AG, Basel 4056, Switzerland.
Sivacharan KolliparaBiopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), Bachupally, Medchal Malkajgiri District, Hyderabad, Telangana 500 090, India.
Evangelos KotzagiorgisEuropean Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands.
Anders LindahlSwedish Medical Products Agency, Uppsala 752 37, Sweden.
Claire MackieJanssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.ORCID 0009-0002-2322-1861
Maria MalamatariMedicines & Healthcare Products Regulatory Agency, London E14 4PU, United Kingdom.ORCID 0000-0003-1144-0629
Amitava MitraClinical Pharmacology, Kura Oncology, Inc., Boston, Massachusetts 02210, United States.
Rebecca MoodyOffice of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.
Xavier PepinRegulatory Strategies Center of Excellence, Simulations Plus, Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States.ORCID 0000-0002-2180-5452
James PolliDepartment of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland 21201, United States.ORCID 0000-0002-5274-4314
Kimberly RainesOffice of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.
Gregory RulloRegulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States.
Maitri SanghaviCertara Predictive Technologies, Level 2-Acero, Simcyp, Ltd., 1 Concourse Way, Sheffield S1 2BJ, United Kingdom.
Rajesh SavkurOffice of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.
Rajendra SinghTeva Branded Pharmaceutical Products R&D, Inc., West Chester, Pennsylvania 19380, United States.
Erik SjögrenPharmetheus, Uppsala 752 37, Sweden.
Sandra Suarez-SharpRegulatory Strategies Center of Excellence, Simulations Plus, Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States.
Sherin ThomasDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States.
Shereeni VeerasinghamPharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott St., Ottawa, Ontario K1A 0K9, Canada.
Kevin WeiOffice of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.
Fang WuDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States.
Yunming XuOffice of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.
Miyoung YoonDivision of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Centre for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland 20993-0002, United States.
Bhagwant RegeOffice of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993-0002, United States.
Funding
FDA HHS U01 FD005946
Abstract
This report summarizes the proceedings for Day 3 of the workshop titled "
Indexed as
BiopharmaceuticsTherapeutic EquivalencyCongresses as TopicDelayed-Action PreparationsDrug DevelopmentDrugs, GenericHumansModels, BiologicalDelayed-Action PreparationsDrugs, Genericclinically relevant dissolution specifications (CRDS)dissolution safe spacedrug product qualitygeneric product developmentpatient centric drug product quality standardsPBBM (physiologically based biopharmaceutics modeling)PBPK (physiologically based pharmacokinetics)regulatory applicationsvirtual bioequivalence (VBE)
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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.