Many companies and global regulatory programs have expressed the intent to move away from in vivo animal testing to new approach methods (NAMs) as part of product safety assessments.
Optimization of Personalized Amlodipine Dosing Strategies for Children Based on Pharmacokinetic Data from Chinese Male Adults and PBPK Modeling
For children, a special population who are continuously developing, a reasonable dosing strategy is the key to clinical therapy.
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Predicting pharmacokinetics of multisource acyclovir oral products through physiologically based biopharmaceutics modeling
Highly variable disposition after oral ingestion of acyclovir has been reported, although little is known regarding the underlying mechanisms.
Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-Space for Ribociclib which has Permeation Rate-Controlled Absorption
A physiologically based biopharmaceutics model (PBBM) was developed to support formulation development of ribociclib, an orally bioavailable selective CDK4/6 inhibitor.
Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Levofloxacin Solution Case Study
Development of generic ophthalmic drug products is challenging due to the complexity of the ocular system and a lack of sensitive testing tools to evaluate its interplay with ophthalmic formulations
Assessing the Potential for Hepatotoxicity for Combination Therapy of Valproate (VPA) and Cannabidiol (CBD) using Quantitative Systems Toxicology (QST)
Highly purified cannabidiol (CBD) (approved as Epidiolex in the US) is efficacious in treating seizures associated with Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and Tuberous Sclerosis Complex (TSC).
In Vivo Extrapolation of Precipitation with Complex Dissolution Experiments
DDDPlus provides complex models to handle: membrane dissolution, biphasic dissolution and artificial stomach duodenum test.
Quantitative Systems Pharmacology Modeling Using NAFLDsym Recapitulated Clinically Observed Histological Responses and Serum Markers to NGM282 in NASH Patients
Nonalcoholic steatohepatitis (NASH) is a growing clinical concern, but currently there is no approved medicine for treatment of NASH. Fibroblast growth...
Gender Related Differences and Pregnancy Induced Changes in Labetalol Glucuronidation Assessed via PBPK Modeling and Simulation
Glucuronidation is considered a major metabolic pathway for drugs containing carboxylic acid, hydroxyl, and amine moieties [1].
Applicability of Existing Prediction Methods to Non-Oral Routes of Delivery
Discuss advances made with PBPK modeling for both oral and non-oral routes for the first in human predictions
MIDD in Preclinical Drug Development
Providing a case for why you should focus on preclinical verification when using Physiologically Based Pharmacokinetic (PBPK) modeling for First-In-Human (F.I.H) pharmacokinetic predictions.
Predicting the Efficacy of Obeticholic Acid Treatment for Non-Alcoholic Steatohepatitis (NASH) Using NAFLDsym, a Quantitative Systems Pharmacology Model of Non-Alcoholic Fatty Liver Disease
Obeticholic acid (OCA), a bile acid analog and agonist of the farnesoid X receptor (FXR), is currently in clinical trials...
Deep eutectic liquid as transdermal delivery vehicle of Risperidone
The work outlined herein describes an evaluation of a green solvent working as a drug solubility and penetration enhancer made up of a deep eutectic system (DES) composed of menthol (MN) and capric acid (CA).