ReviewPharmaceutical research2023
Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs.
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 27 papers.
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
27 citing papers in PubMed.
- Mechanism-based classification of in vitro-in vivo correlation failures and model-informed strategies for drug product development.Archives of pharmacal research · 2026Review
- 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
- Importance of Single Global Regulatory Standards for the Assessment of Generic and Biosimilar Medicines to Advance Patient Access.The AAPS journal · 2026Article
- Evaluation of USP 3 Apparatus to Develop Biopredictive Fasted and Fed Dissolution Methods for Extended-Release Desvenlafaxine Succinate Tablets.ACS omega · 2026Article
- Exploring Additional Strength Biowaiver Perspectives in the ICH M13B Framework for Immediate Release Solid Oral Dosage Forms: Opportunities & Challenges.Therapeutic innovation & regulatory science · 2026Review
- Leveraging Model Integrated Bioequivalence (MIBE) to Address Regulatory Concerns and Waive Repeat Bioequivalence Studies-A Case Study with Clopidogrel.Journal of clinical pharmacology · 2026Article
- Indirect Modeling of Post-Prandial Intestinal Lymphatic Uptake of Halofantrine Using PBPK Approaches: Limitations and Implications.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
- 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
- Formulation Strategy of BCS-II Drugs by Coupling Mechanistic In-Vitro and Nonclinical In-Vivo Data with PBPK: Fundamentals of Absorption-Dissolution to Parameterization of Modelling and Simulation.AAPS PharmSciTech · 2025Review
- Virtual Bioequivalence Assessment of Tofacitinib Once Daily Modified Release Dosage Form in Pediatric Subjects.The AAPS journal · 2025Article
- Physiologically-Based Biopharmaceutics Modeling for Ibuprofen: Identifying Key Formulation Parameter and Virtual Bioequivalence Assessment.Pharmaceutics · 2025Article
- Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report.Molecular pharmaceutics · 2025Article
- Establishment of Biopredictive Dissolution and Bioequivalence Safe Space Using the Physiologically Based Biopharmaceutics Modeling for Tacrolimus Extended-Release Capsules.AAPS PharmSciTech · 2024Article
- Physiologically Based Biopharmaceutics Modeling Coupled with Biopredictive Dissolution in Development of Bioequivalent Formulation for Mesalamine Enteric Coated Tablet: A Tough Nut to Crack.AAPS PharmSciTech · 2024Article
- A critical review on approaches to generate and validate virtual population for physiologically based pharmacokinetic models: Methodologies, case studies and way forward.European journal of clinical pharmacology · 2024Review
- A Semi-Mechanistic Physiologically Based Biopharmaceutics Model to Describe Complex and Saturable Absorption of Metformin: Justification of Dissolution Specifications for Extended Release Formulation.AAPS PharmSciTech · 2024Article
- Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges?The AAPS journal · 2024Review
- Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space.The AAPS journal · 2024Article
- Conventional vs Mechanistic IVIVC: A Comparative Study in Establishing Dissolution Safe Space for Extended Release Formulations.AAPS PharmSciTech · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
For successful oral drug development, defining a bioequivalence (BE) safe space is critical for the identification of newer bioequivalent formulations or for setting of clinically relevant in vitro specifications to ensure drug product quality. By definition, the safe space delineates the dissolution profile boundaries or other drug product quality attributes, within which the drug product variants are anticipated to be bioequivalent. Defining a BE safe space with physiologically based biopharmaceutics model (PBBM) allows the establishment of mechanistic in vitro and in vivo relationships (IVIVR) to better understand absorption mechanism and critical bioavailability attributes (CBA). Detailed case studies on how to use PBBM to establish a BE safe space for both innovator and generic drugs are described. New case studies and literature examples demonstrate BE safe space applications such as how to set in vitro dissolution/particle size distribution (PSD) specifications, widen dissolution specification to supersede f2 tests, or application toward a scale-up and post-approval changes (SUPAC) biowaiver. A workflow for detailed PBBM set-up and common clinical study data requirements to establish the safe space and knowledge space are discussed. Approaches to model in vitro dissolution profiles i.e. the diffusion layer model (DLM), Takano and Johnson models or the fitted PSD and Weibull function are described with a decision tree. The conduct of parameter sensitivity analyses on kinetic dissolution parameters for safe space and virtual bioequivalence (VBE) modeling for innovator and generic drugs are shared. The necessity for biopredictive dissolution method development and challenges with PBBM development and acceptance criteria are described.
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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.