ArticleClinical pharmacology and therapeutics2020
Evaluating the Role of Solubility in Oral Absorption of Poorly Water-Soluble Drugs Using Physiologically-Based Pharmacokinetic Modeling.
Article in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.
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Who cites it
35 citing papers in PubMed.
- Physiologically Based Pharmacokinetic Modeling for Mechanistic Analysis of Food Effects: A Case Study with Radotinib.Pharmaceutical research · 2026Article
- Co-amorphization for solubility and dissolution rate improvement: the case of low-crystallization-tendency drugs.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026Review
- Article
- Fatty Acid-enriched Euphorbia neriifolia Alleviates the NPIP-induced Lung Cancer Via Modulating Oxidative Stress and Apoptosis in Swiss Albino Mice.Cell biochemistry and biophysics · 2026Article
- Structure-Activity Relationship Studies for 1,3,4-Thiadiazole-Based Bacterial Carbonic Anhydrase Inhibitors withJournal of medicinal chemistry · 2026Article
- Physiologically Based Pharmacokinetic (PBPK) Modeling of Oral Drug Absorption for Integrating Nonclinical Data into Human Pharmacokinetic Predictions.The AAPS journal · 2026Review
- PEGASUS: Unlocking Polarity in Cell-Permeable Cyclic Peptides Using AI Models Built on Massively Parallel Biological Assays.Journal of medicinal chemistry · 2026Article
- Enzymatic Glucosylation Enhances the Solubility of Niclosamide but Abrogates Its Therapeutic Efficacy.ACS omega · 2026Article
- Article
- Data-Driven Classification of Solubility Space in Deep Eutectic Solvents: Deciphering Driving Forces Using PCA and K-Means Clustering.Molecules (Basel, Switzerland) · 2025Article
- Enhancing the pharmacokinetics of abiraterone acetate through lipid-based formulations: addressing solubility and food effect challenges.Drug delivery and translational research · 2025Article
- Pyrroloquinolone-Based Compounds as a Novel Antimycobacterial Chemotype.ACS medicinal chemistry letters · 2025Article
- Novel Indole-Thiazole Derivative Containing aACS omega · 2025Article
- Evaluation of Solubility-Limited Absorption as a Surrogate to Predicting Positive Food Effect of BCS II/IV Drugs.Clinical pharmacokinetics · 2025Article
- Solubility-Limited Absorption Identified by a Simplified PBPK Model for the Prediction of Positive Food Effect for BCS II/IV Drugs.Clinical pharmacokinetics · 2025Article
- Article
- Comparative assessment of physics-based in silico methods to calculate relative solubilities.Journal of computer-aided molecular design · 2024Article
- Optimization of Ethoxzolamide Analogs with Improved Pharmacokinetic Properties forJournal of medicinal chemistry · 2024Article
- IR-EcoSpectra: Exploring sustainableJournal of pharmaceutical analysis · 2024Review
- RationalJournal of medicinal chemistry · 2024Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Poor aqueous solubility and dissolution of drug candidates drive key decisions on lead series optimization during drug discovery, on formulation optimization, and clinical studies planning during drug development. The interpretation of the in vivo relevance of early pharmaceutical profiling is often confounded by the multiple factors affecting oral systemic exposure. There is growing evidence that in vitro drug solubility may underestimate the true in vivo solubility and lead to drug misclassification. Based on 10 poorly water-soluble tyrosine kinase inhibitors, this paper demonstrates the use of physiologically-based pharmacokinetic (PK) analysis in combination with early clinical PK data to identify drugs whose absorption is truly limited by solubility in vivo and, therefore, expected to exhibit food effect. Our study supports a totality of evidence approach using early clinical data to guide decisions on conducting drug interaction studies with food and acid-reducing agents.
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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.