ReviewThe AAPS journal2013
Dose selection based on physiologically based pharmacokinetic (PBPK) approaches.
Review in The AAPS journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 47 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.
Clinical Lactation Study on the Exposure to Medicines Via Human Milk: an Umbrella Study Protocol
Maternal Treatment With ACE-inhibitors and Breastfeeding: a Mono-centric Study on the Exposure Through Breast Milk
Who cites it
47 citing papers in PubMed.
- Model-informed dose optimization of carvedilol and nebivolol in cirrhotic patients: a pilot randomized clinical study.Scientific reports · 2026Trial
- Modeling and Simulation of the Pharmacokinetics and Target Engagement of an Antagonist Monoclonal Antibody to Interferon-γ-Induced Protein 10, BMS-986184, in Healthy Participants to Guide Therapeutic Dosing.Clinical pharmacology in drug development · 2020Trial
- Physiologically Based Pharmacokinetic Modeling of Vedolizumab in Healthy Adults and Patients with Inflammatory Bowel Disease.Clinical pharmacokinetics · 2026Article
- Using Physiologically Based Pharmacokinetic Modeling and Simulations to Predict Antihypertensive Drug Doses in Cirrhotic Patients.Journal of clinical pharmacology · 2026Article
- PBPK Modeling: Empowering Drug Development and Precision Dosing in China.CPT: pharmacometrics & systems pharmacology · 2025Review
- NNKcat: deep neural network to predict catalytic constants (Kcat) by integrating protein sequence and substrate structure with enhanced data imbalance handling.Briefings in bioinformatics · 2025Article
- Quantitative Systems Pharmacology Model to Predict Target Occupancy by Bruton Tyrosine Kinase Inhibitors in Patients With B-Cell Malignancies.CPT: pharmacometrics & systems pharmacology · 2025Article
- Exploring neuropharmacokinetics: mechanisms, models, and clinical implications.Encephalitis (Seoul, Korea) · 2025Article
- A preliminary exploration of liver microsomes and PBPK to uncover the impact of CYP3A4/5 and CYP2C19 on tacrolimus and voriconazole drug-drug interactions.Scientific reports · 2025Article
- Prediction of SPT-07A Pharmacokinetics in Rats, Dogs, and Humans Using a Physiologically-Based Pharmacokinetic Model and In Vitro Data.Pharmaceutics · 2024Article
- Model-Based Dose Selection of a Sphingosine-1-Phosphate Modulator, Etrasimod, in Patients with Various Degrees of Hepatic Impairment.Pharmaceutics · 2024Article
- Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol-a contribution from the ConcePTION project.BMJ paediatrics open · 2024Article
- A physiologically based pharmacokinetic model to optimize the dosage regimen and withdrawal time of cefquinome in pigs.PLoS computational biology · 2023Article
- All Roads Lead to Rome: Enhancing the Probability of Target Attainment with Different Pharmacokinetic/Pharmacodynamic Modelling Approaches.Antibiotics (Basel, Switzerland) · 2023Review
- Investigation of simplified physiologically-based pharmacokinetic models in rat and human.CPT: pharmacometrics & systems pharmacology · 2023Article
- Practical Understanding of Cancer Model Identifiability in Clinical Applications.Life (Basel, Switzerland) · 2023Article
- Addressing systemic problems with exposure assessments to protect the public's health.Environmental health : a global access science source · 2023Review
- Optimization and Validation of Dosage Regimen for Ceftiofur againstInternational journal of molecular sciences · 2022Article
- Differences in P-glycoprotein activity in human and rodent blood-brain barrier assessed by mechanistic modelling.Archives of toxicology · 2021Article
- A Mechanistic Site-Of-Action Model: A Tool for Informing Right Target, Right Compound, And Right Dose for Therapeutic Antagonistic Antibody Programs.Frontiers in bioinformatics · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Physiologically based pharmacokinetic (PBPK) models are built using differential equations to describe the physiology/anatomy of different biological systems. Readily available in vitro and in vivo preclinical data can be incorporated into these models to not only estimate pharmacokinetic (PK) parameters and plasma concentration-time profiles, but also to gain mechanistic insight into compound properties. They provide a mechanistic framework to understand and extrapolate PK and dose across in vitro and in vivo systems and across different species, populations and disease states. Using small molecule and large molecule examples from the literature and our own company, we have shown how PBPK techniques can be utilised for human PK and dose prediction. Such approaches have the potential to increase efficiency, reduce the need for animal studies, replace clinical trials and increase PK understanding. Given the mechanistic nature of these models, the future use of PBPK modelling in drug discovery and development is promising, however some limitations need to be addressed to realise its application and utility more broadly.
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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.