ArticlePharmaceutical research2023
Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation.
Article in Pharmaceutical research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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The trial behind it
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Who cites it
9 citing papers in PubMed, 15 citations in OpenAlex.
- Development of a novel rabeprazole modified release formulation to reduce the dosing frequency: A trial and triumph with physiologically based biopharmaceutics modeling.Journal of pharmacokinetics and pharmacodynamics · 2026Trial
- Impact of Mechanistic Modeling and Simulation Methodologies on Product-Specific Guidance Development for Non-Orally Administered Drug Products.CPT: pharmacometrics & systems pharmacology · 2025Review
- Quasi-3D Mechanistic Model for Predicting Eye Drop Distribution in the Human Tear Film.Bioengineering (Basel, Switzerland) · 2025Article
- Ocular Tissue Distribution of Omidenepag Isopropyl in Rabbits and Cynomolgus Monkeys.Translational vision science & technology · 2024Article
- Mathematical Models of Ocular Drug Delivery.Investigative ophthalmology & visual science · 2024Review
- Clinical Ocular Exposure Extrapolation for a Complex Ophthalmic Suspension Using Physiologically Based Pharmacokinetic Modeling and Simulation.Pharmaceutics · 2024Article
- Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products.The AAPS journal · 2024Review
- Quantitative systems pharmacology of the eye: Tools and data for ocular QSP.CPT: pharmacometrics & systems pharmacology · 2023Review
- Simultaneous Determination of Moxifloxacin Hydrochloride and Dexamethasone Sodium Phosphate in Rabbit Ocular Tissues and Plasma by LC-MS/MS: Application for Pharmacokinetics Studies.Molecules (Basel, Switzerland) · 2022Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundThe development of generic ophthalmic drug products is challenging due to the complexity of the ocular system, and a lack of sensitive testing to evaluate the interplay of physiology with ophthalmic formulations. While measurements of drug concentration at the site of action in humans are typically sparse, these measurements are more easily obtained in rabbits. The purpose of this study is to demonstrate the utility of an ocular physiologically based pharmacokinetic (PBPK) model for translation of ocular exposure from rabbit to human.
methodThe Ocular Compartmental Absorption and Transit (OCAT™) model within GastroPlus® v9.8.2 was used to build PBPK models for levofloxacin (Lev), moxifloxacin (Mox), and gatifloxacin (Gat) ophthalmic solutions. in the rabbit eye. The models were subsequently used to predict Lev, Mox, and Gat exposure after ocular solution administrations in humans. Drug-specific parameters were used as fitted and validated in the rabbit OCAT model. The physiological parameters were scaled to match human ocular physiology.
resultsOCAT model simulations for rabbit well described the observed concentrations in the eye compartments following Lev, Mox, and Gat solution administrations of different doses and various administration schedules. The clinical ocular exposure following ocular administration of Lev, Mox, and Gat solutions at different doses and various administration schedules was well predicted.
conclusionEven though additional case studies for different types of active pharmaceutical ingredients (APIs) and formulations will be needed, the current study represents an important step in the validation of the extrapolation method to predict human ocular exposure for ophthalmic drug products using PBPK models.
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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.