While biologics offer promise in addressing a range of unmet medical needs, clinically observed BILI events are concerning for drug developers, health care providers and patients.
Predicting Brinzolamide Ocular Response in Humans Using an Ocular PBPK-PD Modeling and Simulation
The development of generic ophthalmic drug products indicated for intraocular pressure (IOP) reduction typically relies on comparative pharmacodynamic (PD) endpoint bioequivalence (BE) studies.
Clustering of Environmental Compounds Based on Structure and Toxicokinetic Properties
Traditional toxicokinetic (TK) models rely heavily on in vivo data, necessitating animal testing. At the same time, the scientific toolbox is expanding with new approach methodologies (NAMs) that do not rely on TK studies.
Accurate Prediction of Liver Fat Reductions Across Range of Weight Loss by Quantitative Systems Pharmacology Modeling
Weight loss has positive effects on reducing hepatic lipid burden in MASH patients. Reports using various...
Quantitative Systems Toxicology Modeling of Otenaproxesul Liver Enzyme Elevations Leads to Prediction of Liver Safety for Acute Otenaproxesul Dosing
Otenaproxesul (ATB-346), a drug that combines naproxen with a thiobenzamide antioxidant, is being developed as an NSAID that reduces gut toxicity effects. Liver...
Physiologically Based Pharmacokinetic Models for Infliximab, Ipilimumab, and Nivolumab Developed with GastroPlus® to Predict Hepatic Concentrations
Infliximab (IFX), ipilimumab (IPI), and nivolumab (NIVO) have been associated with hepatotoxicity...
Simulated CD8+ T Cell-Mediated Liver Injury During Ipilimumab Administration in a Simulated Population (SimPops®) Demonstrates Profiles Consistent with Observed Clinical Data
Immune checkpoint inhibitors (ICIs) have revolutionized treatment of various cancers. They act by releasing the brakes on immune responses to permit immune-mediated tumor cell killing...
Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model
The recent availability of effective GLP-1R agonist (GLP-1RA) based treatments of obesity has provided great benefit to patients. Understanding the balance between body weight (BW) loss...
Comparison of Sensitivity Analysis Methods in the Context of a QSP Model for Gout
As quantitative systems pharmacology (QSP) models are increasingly used to inform key...
Eculizumab as a Key Comparator for the Evaluation of Complement Targeted Novel Therapeutic Strategies with a QSP Model
Paroxysmal nocturnal hemoglobinuria (PNH) is one of multiple diseases in which complement dysregulation, leading to...
Modeling progression and treatment of prostate cancer using the Thales QSP software platform
Metastatic, castration resistant prostate cancer (mCRPC) is an aggressive form of prostate cancer in...
Weight Loss and Nausea from Subcutaneous and Oral Semaglutide Accurately Simulated with a QSP Model
The availability of effective GLP-1 receptor agonists (GLP-1RAs) for obesity treatment has greatly benefited patients. Balancing body weight (BW) loss with nausea is crucial to predict the effectiveness of these medications, along with understanding the impact of delivery methods. Quantitative Systems Pharmacology (QSP) modeling helps predict efficacy and adverse events, assessing key differences and similarities between treatment protocols.
Weight Loss and Nausea from Obesity Treatments are Accurately Simulated with OBESITYsym
The recent availability of effective, GLP-1R agonist (GLP-1RA) based treatments of obesity has provided...
Mechanistic Representation of Clusterin, a Damage Biomarker for Early Detection of Drug-induced AKI
Novel biomarkers have the potential to address early diagnosis and...
Orforglipron Weight Loss and Nausea Accurately Simulated with OBESITYsym
The recent availability of effective, GLP-1R agonist (GLP-1RA) based treatments of obesity has provided great benefit to patients
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)
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