This work shows the utilization of a physiologically based biopharmaceutics model (PBBM) to mechanistically explain the impact of diverse food types on the pharmacokinetics (PK) of isoniazid (INH) and acetyl-isoniazid (Ac-INH).
Evaluation of the Dissolution Behavior of Etodolac Tablers Using Physiologically Based Biopharmaceutics Modeling (PBBM) Approach
Etodolac is a non-steroidal, anti-inflammatory, acidic molecule (pKa 4.65) with pH-dependent solubility and classified as a BCS class II drug [1].
Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables
Long-acting injectable (LAI) formulations provide sustained drug release over an extended period ranging from weeks to several months to improve efficacy, safety, and compliance.
DDIs: How to Use Your Predictions to Support Regulatory Submission
Identifying potential drug-drug interactions (DDIs) is critical to your program's success.
InnoGI Technologies and Simulations Plus Combine Forces to Offer Next-Level Modeling Solutions for the Prediction of Oral Drug Performance
InnoGI Technologies (formerly The TIM Company) is pleased to announce an exciting, market-driven collaboration with Simulations Plus to combine its TIM Technology, part of the InnoGI SurroGUT™ platform, with the GastroPlus® and ADMET Predictor® modelling software offered by Simulations Plus.
April 2024 News/Events
How to Use Your Predictions to Support Regulatory Submission
Women in Science: Camila de Almeida, Director of Clinical Pharmacology
Dr. Camila de Almeida, Director of Clinical Pharmacology at Simulations Plus, shares her proudest accomplishments, career trajectory, and words of advice for future women in science.
Targeting Complement to Reduce Disease Activity: Quantitative Systems Pharmacology (QSP) to Enhance Efficient Drug Development: Part One
Deficiency or dysfunction in regulatory factors that control the complement cascade critically contribute to several rare diseases...
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report
Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body.
Development and application of the physiologically-based toxicokinetic (PBTK) model for ochratoxin A (OTA) in rats and humans
Ochratoxin A (OTA) is a common fungal toxin frequently detected in food and human plasma samples.
Exploring Lead-Like Molecules of Traditional Chinese Medicine for Treatment Quest against Aliarcobacter butzleri: In Silico Toxicity Assessment, Dynamics Simulation, and Pharmacokinetic Profiling
Aliarcobacter butzleri is a Gram-negative, curved or spiral-shaped, microaerophilic bacterium and causes human infections, specifically diarrhea, fever, and sepsis.
Validation of a Caco-2 microfluidic Chip model for predicting intestinal absorption of BCS Class I-IV drugs
Oral delivery is considered the most patient preferred route of drug administration, however, the drug must be sufficiently soluble and permeable to successfully formulate an oral formulation.
Predictions of tissue concentrations of myclobutanil, oxyfluorfen, and pronamide in rat and human after oral exposures via GastroPlusTM physiologically based pharmacokinetic modelling
Heritage agrochemicals like myclobutanil, oxyfluorfen, and pronamide, are extensively used in agriculture, with well-established studies on their animal toxicity.
Best of Both Worlds: An Expansion of the State of the Art pKa Model with Data from Three Industrial Partners
In a unique collaboration between Simulations Plus and several industrial partners, we were able to develop a new version 11.0 of the previously published1 in silico pKa model, S+pKa, with considerably improved prediction accuracy.
U.S. FDA Renews DILIsym® Software Licenses for 7th Year
Predicting DILI risk supports informed decision-making regarding drug evaluations and approvals
Simulations Plus Reports Second Quarter Fiscal 2024 Financial Results
Total revenue of $18.3 million and diluted earnings per share (EPS) of $0.20
April 2024 GastroPlus Newsletter
GastroPlus® Monthly Newsletter 2024
Construction of a Simulated Population of Post-Menopausal Women for the Prediction of Drug-Induced Liver Injury (DILI)
ASCPT 2024: Construction of a Simulated Population of Post-Menopausal Women for the Prediction of Drug-Induced Liver Injury (DILI)
A Biomarker-Focused QSP Model of Complement Alternative and Terminal Pathways to Evaluate Potential Targets for Therapeutic Impact in Complement-Associated Diseases: Paroxysmal Nocturnal Hemoglobinuria (PNH) as a Case Study
Complement overactivity has been implicated in multiple diseases, including PNH...