Using PBPK to Establish In Vitro-In Vivo Relationship for Budesonide Delayed Release Oral Drug Product
Budesonide is a corticosteroid used to treat inflammatory bowel diseases (IBD) (1)
PK/PD Modeling Made Simple
Modeling is increasingly important for the speed and success of our drug development programs, but the learning curve to be effective can be high.
Delineating the Role of Transporters in the Absorption and Disposition of Digoxin Using the Physiologically Based Pharmacokinetic (PBPK) Modeling
Digoxin (DIG) is one of the cardiac glycosides that inhibits sodium-potassium ATPase, an enzyme that regulates the intracellular concentration of sodium and potassium.
Enhanced PBPK-Based In Vitro to In Vivo Extrapolation Method to Support the Development of Pulmonary Drug Products
Orally inhaled drug products (OIDPs) are used to treat pulmonary diseases. OIDP absorption occurs in three phases: deposition, dissolution, and permeation.
Mechanistic in vitro Oral Absorption Model to Predict Mucosal Permeability of Oral Cavity Drug Products
Buccal delivery allows patient compliance, ease of drug administration and potential bypass of first-pass metabolism
Mechanistic Model of in vitor Intraoral Absorption of Buprenorphine for the Buccal and Gingival Mucosa
Long-term use of buprenorphine oral cavity drug products (DP) poses risks of dental issues [1] and the underlying reason is not well understood
Integration of Gut Microbiome Metabolism in a PBBM-PBPK Model: its impact on the Sulfasalazine absorption
Inflammatory bowel disease (IBD) is a recurrent or continuous inflammation of the bowel that affects 1.4 million patients in the United States.
Dermal PBPK Model For Psoriatic Skin: Clobetasol Propionate Case Study
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.
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