ArticleThe AAPS journal2019
PBPK Absorption Modeling: Establishing the In Vitro-In Vivo Link-Industry Perspective.
Article in The AAPS journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 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.
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.
- Exploration of IVIVC Deconvolution Methods in a PBPK Platform: Case Example with Tofacitinib.The AAPS journal · 2026Trial
- Mechanism-based classification of in vitro-in vivo correlation failures and model-informed strategies for drug product development.Archives of pharmacal research · 2026Review
- Minimal Physiologically-Based Pharmacokinetic Modeling to Predict Concentration-Time Profiles of Poorly Soluble Cinacalcet Hydrochloride in Fasting and Fed State.European journal of drug metabolism and pharmacokinetics · 2026Article
- Modernizing Preclinical Drug Development: The Role of New Approach Methodologies.ACS pharmacology & translational science · 2025Review
- 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
- Physiologically Based Pharmacokinetic Modeling of Cannabidiol, Delta-9-Tetrahydrocannabinol, and Their Metabolites in Healthy Adults After Administration by Multiple Routes.Clinical and translational science · 2025Article
- Physiologically Based Pharmacokinetic Modeling to Assess Ritonavir-Digoxin Interactions and Recommendations for Co-Administration Regimens.Pharmaceutical research · 2024Article
- Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space.The AAPS journal · 2024Article
- In Vivo Predictive Dissolution and Biopharmaceutic-Based In Silico Model to Explain Bioequivalence Results of Valsartan, a Biopharmaceutics Classification System Class IV Drug.Pharmaceutics · 2024Article
- Model-Informed Drug Development: In Silico Assessment of Drug Bioperformance following Oral and Percutaneous Administration.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Physiologically based pharmacokinetic modeling of levetiracetam to predict the exposure in hepatic and renal impairment and elderly populations.CPT: pharmacometrics & systems pharmacology · 2023Article
- Evaluating the bioequivalence of two pitavastatin calcium formulations based on IVIVC modeling and clinical study.Clinical and translational science · 2023Article
- In-Depth Analysis of Physiologically Based Pharmacokinetic (PBPK) Modeling Utilization in Different Application Fields Using Text Mining Tools.Pharmaceutics · 2022Review
- Towards best use and regulatory acceptance of generic physiologically based kinetic (PBK) models for in vitro-to-in vivo extrapolation (IVIVE) in chemical risk assessment.Archives of toxicology · 2022Article
- Establishment of Level a In Vitro-In Vivo Correlation (IVIVC) via Extended DoE-IVIVC Model: A Donepezil Case Study.Pharmaceutics · 2022Article
- Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series.Pharmaceutics · 2022Article
- In Vitro-In Vivo Correlation of Tianeptine Sodium Sustained-Release Dual-Layer Tablets.Molecules (Basel, Switzerland) · 2022Article
- Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms.The AAPS journal · 2022Review
- Predicting Food Effects: Are We There Yet?The AAPS journal · 2022Article
- In Silico Modeling and Simulation to Guide Bioequivalence Testing for Oral Drugs in a Virtual Population.Clinical pharmacokinetics · 2021Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The establishment of an in vitro-in vivo correlation (IVIVC) is considered the gold standard to establish in vivo relevance of a dissolution method and to utilize dissolution data in the context of regulatory bioequivalence questions, including the development of dissolution specifications. However, several recent publications, including industry surveys and reviews from regulatory agencies, have indicated a low success rate for IVIVCs, especially for immediate-release formulations. In recent years, the use of physiologically based pharmacokinetics (PBPK) and absorption modeling, as a tool to facilitate formulation development, has been attracting increased attention. This manuscript provides an industry perspective on the current challenges with establishing IVIVCs and the potential PBPK and absorption modeling offer to increase their impact. Case studies across both immediate-release and extended-release formulations from five pharmaceutical companies are utilized to demonstrate how physiologically based IVIVC (PB-IVIVC) may facilitate drug product understanding and to inform bioequivalence assessment and clinically relevant specifications. Finally, PB-IVIVC best practices and a strategy for model development and application are proposed.
Indexed as
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30673891What 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.