PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Metabolism in Pregnant Subjects and Fetuses

PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Metabolism in Pregnant Subjects and Fetuses

Publication: Pharmaceutics
Software: GastroPlus®
Therapeutic Areas: PBPK

This study aimed to develop a physiologically based pharmacokinetic (PBPK) model that simulates metabolically cleared compounds’ pharmacokinetics (PK) in pregnant subjects and fetuses.

Pharmacokinetic model of human exposure to ciprofloxacin through consumption of fish

Pharmacokinetic model of human exposure to ciprofloxacin through consumption of fish

Publication: Environ Toxicol Pharmacol
Software: GastroPlus®
Division: PBPK

Fluoroquinolones are broad-spectrum antibiotics that accumulate in the environment.

Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products

Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products

Publication: AAPS J
Software: GastroPlus®
Division: PBPK

Evidence shows that there is an increasing use of modeling and simulation to support product development and approval for complex generic drug products in the USA, which includes the use of mechanistic modeling and model-integrated evidence (MIE).

An Integrated Computational Approaches for Designing of Potential Piperidine based Inhibitors of Alzheimer Disease by Targeting Cholinesterase and Monoamine Oxidases Isoenzymes

An Integrated Computational Approaches for Designing of Potential Piperidine based Inhibitors of Alzheimer Disease by Targeting Cholinesterase and Monoamine Oxidases Isoenzymes

Publication: Appl Biochem Biotechnol

The study aimed to evaluate the potential of piperidine-based 2H chromen-2-one derivatives against targeted enzymes, i.e., cholinesterase’s and monoamine oxidase enzymes.

Oligoadenylate Synthetases 1 Enhances DNA Sensor Cgas Translation to Mediate Antiviral Activity

Oligoadenylate Synthetases 1 Enhances DNA Sensor Cgas Translation to Mediate Antiviral Activity

Publication: SSRN Electronic Journal

Oligoadenylate synthetases (OAS) are a family of interferon (IFN)-stimulated genes known to inhibit viral replication through the enzymatic synthesis of 2'-5' oligoadenylates and activation of Ribonuclease L.

Prediction of pharmacokinetics of an anaplastic lymphoma kinase inhibitor in rat and monkey: application of physiologically based pharmacokinetic model as an alternative tool to minimise animal studies

Prediction of pharmacokinetics of an anaplastic lymphoma kinase inhibitor in rat and monkey: application of physiologically based pharmacokinetic model as an alternative tool to minimise animal studies

Publication: Xenobiotica
Software: GastroPlus®

The pharmacokinetic (PK) and toxicokinetic profile of a drug from its preclinical evaluation helps the researcher determine whether the drug should be tested in humans based on its safety and toxicity.

Evaluating the Role of N-Acetyl-L-Tryptophan in the Aβ 1-42-Induced Neuroinflammation and Cognitive Decline in Alzheimer’s Disease

Evaluating the Role of N-Acetyl-L-Tryptophan in the Aβ 1-42-Induced Neuroinflammation and Cognitive Decline in Alzheimer’s Disease

Publication: Mol Neurobio
Software: GastroPlus®

Alzheimer’s disease (https://www.simulations-plus.com/wp-admin/post.php?post=35654&action=editAD), a neurodegenerative condition previously known to affect the older population, is also now seen in younger individuals.

Log D7.4 and plasma protein binding of synthetic cannabinoid receptor agonists and a comparison of experimental and predicted lipophilicity

Log D7.4 and plasma protein binding of synthetic cannabinoid receptor agonists and a comparison of experimental and predicted lipophilicity

Publication: Drug Test Anal
Software: GastroPlus®

The emergence of new synthetic cannabinoid receptor agonists (SCRAs) onto the illicit drugs market continues to cause harm, and the overall availability of physicochemical and pharmacokinetic data for new psychoactive substances is lacking.

Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives

Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives

Publication: J Pharm Sci
Software: GastroPlus®

Over the past few decades, physiologically based biopharmaceutics modeling (PBBM) has demonstrated its utility in both new drug and generic product development.

In silico prediction of bioequivalence of atorvastatin tablets based on GastroPlus™ software

In silico prediction of bioequivalence of atorvastatin tablets based on GastroPlus™ software

Publication: BMC Pharmacol Toxicol
Software: GastroPlus®

The prediction of intestinal absorption of various drugs based on computer simulations has been a reality.

Cross species extrapolation of the disruption of thyroid hormone synthesis by oxyfluorfen using in vitro data, physiologically based pharmacokinetic (PBPK), and thyroid hormone kinetics models

Cross species extrapolation of the disruption of thyroid hormone synthesis by oxyfluorfen using in vitro data, physiologically based pharmacokinetic (PBPK), and thyroid hormone kinetics models

Publication: Curr Res Toxicol
Software: GastroPlus®

The thyroid hormones play key roles in physiological processes such as regulation of the metabolic and cardiac systems as well as the development of the brain and surrounding sympathetic nervous system.

Predicting the pharmacokinetics and pharmacodynamics of antisense oligonucleotides: an overview of various approaches and opportunities for PBPK/PD modelling

Predicting the pharmacokinetics and pharmacodynamics of antisense oligonucleotides: an overview of various approaches and opportunities for PBPK/PD modelling

Publication: Expert Opin Drug Metab Toxicol
Software: GastroPlus®

Advances in research and development (R&D) have enabled many approvals of antisense oligonucleotides (ASOs). Its administration expanded from systemic to local for treating various diseases, where predicting target tissue exposures and pharmacokinetics (PK) and pharmacodynamics (PD) in human can be critical.

Physiologically Based Pharmacokinetic modelling of drugs in pregnancy: A mini-review on availability and limitations

Physiologically Based Pharmacokinetic modelling of drugs in pregnancy: A mini-review on availability and limitations

Publication: Fundam Clin Pharmacol
Software: GastroPlus®

Physiologically based pharmacokinetic (PBPK) modelling in pregnancy is a relatively new approach that is increasingly being used to assess drug systemic exposure in pregnant women to potentially inform dosing adjustments.

Contribution of the Dynamic Intestinal Absorption Model (Diamod) to the Development of a Patient-Centric Drug Formulation

Contribution of the Dynamic Intestinal Absorption Model (Diamod) to the Development of a Patient-Centric Drug Formulation

Publication: Mol Pharm
Software: GastroPlus®

Compound X is a weak basic drug targeting the early stages of Parkinson’s disease, for which a theoretical risk assessment has indicated that elevated gastric pH conditions could potentially result in reduced plasma concentrations.