Psoriasis is a chronic inflammatory disease often treated by drug products applied on the skin surface, and it is well accepted that disease-mediated physiological changes in the skin can significantly affect the permeation of active pharmaceutical ingredients (APIs) through the skin layers.
Landscape of regulatory quantitative systems pharmacology submissions to the U.S. Food and Drug Administration: An update report
The number of quantitative systems pharmacology (QSP) submissions to the U.S. Food and Drug Administration has continued to increase over the past decade.
Advancing Scientific Development with Collaborations
15+ FDA grants and $5M+ in funding & new feature developments since 2014
Transforming Clinical Trial Training for Enhanced Patient Trust
Patient trust is critical for ensuring adequate enrollment and retention of clinical trial participants.
Boosting Patient Safety with Risk-Free Adaptive Learning
Patient safety is paramount in any clinical trial.
Bioequivalence Requirements for Orally Inhaled and Nasal Drug Products and Use of Novel Physiologically Based Biopharmaceutics Modeling Approaches for Assessing In Vivo Performance
Orally inhaled and nasal drug products (OINDPs) are complex due to the interplay between the device, formulation, and patient characteristics.
Justification of widened dissolution specifications of an extended-release product using physiologically based biopharmaceutics modeling
Drug products meeting the dissolution specifications is crucial in order to ensure consistent clinical performance.
Preclinical Assessment of the PI3Kα Selective Inhibitor Inavolisib and Prediction of Its Pharmacokinetics and Efficacious Dose in Human
Small molecule inhibitors of the PI3K pathway have been extensively investigated as potential anticancer agents. Among the effectors in this pathway
A critical review on approaches to generate and validate virtual population for physiologically based pharmacokinetic models: Methodologies, case studies and way forward
In silico modeling and simulation techniques such as physiologically based pharmacokinetic (PBPK) and physiologically based biopharmaceutics modeling (PBBM) have demonstrated various applications in drug discovery and development.
GP AP Module Flyer
The ADMET Predictor Module uses enhanced pk models developed with greater accuracy. It uses the same QSPR models as our best-inclass ADMET Predictor standalone software.
GP DDI Module Flyer
The DDI Module in GastroPlus allows you to predict mechanistic and static drug-drug interactions (DDIs) among unlimited drugs and metabolites.
GP PKPlus™ Module Flyer
The fitted parameters include PK properties, first orderabsorption rate, bioavailability and absorption lag time.
Simulations Plus and the University of Southern California Secure NIH Grant to Develop New AI Drug Discovery Offerings
Partnership will advance the field of ligand-based virtual screening to improve drug design and optimization activities
The Case for PK Simulations in Early Drug Discovery
You’re the head of medicinal chemistry. Your focus is on developing molecules that balance (often conflicting) objectives to achieve the target compound profile, and it consumes every spare minute.
RENAsym Flyer
RENAsym Predict and Prevent Drug-Induced Kidney Injury
PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report
The proceedings from the 30th August 2023 (Day 2) of the workshop “Physiologically Based Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives” are provided herein.
Preparation and Evaluation of Nanolipid Carriers of Bedaquiline- In vitro Evaluation and in silico Prediction
Bedaquiline, a potent antitubercular drug used in the treatment of multidrug-resistant strains, suffers from low oral bioavailability, a slow onset of therapeutic action, and side effects.
Synthesis, Absolute Configuration, Biological Profile and Antiproliferative Activity of New 3,5-Disubstituted Hydantoins
Hydantoins, a class of five-membered heterocyclic compounds, exhibit diverse biological activities.
Leveraging PBPK/PBBM in Support of BCS Class 3 Biowaivers
It is critical to understand the perspectives and key criteria of global regulatory agencies in the consideration of biowaivers, but many companies have knowledge gaps that hinder their success.
Advancing the Harmonization of Biopredictive Methodologies through the Product Quality Research Institute (PQRI) Consortium: Biopredictive Dissolution of Dipyridamole Tablets
Biorelevant dissolution and its concept have been widely accepted and further developed to meaningfully predict the bioperformance of oral drug products.