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
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.
Systematic Evaluation of Underlying Models That Improve Purely In-Silico High-Throughput Mechanistic Pbpk Predictions Across Species
The ability to quickly and accurately predict key PK properties based solely on chemical structure can aid in several tasks.
Multicriteria Decision Aiding in the service of Drug Discovery
Drug discovery is inherently a multicriteria optimization problem.
Predicting dose-dependent fraction absorbed via a mechanistic absorption model and machine learning
Drug dissolution and absorption are crucial in oral drug delivery.
Pemvidutide, a glucagon-like peptide 1/glucagon dual receptor agonist, improves metabolic dysfunction-associated steatohepatitis activity and fibrosis in a clinical quantitative systems pharmacology model
Elevated liver fat content (LFC) is the primary pathophysiologic driver of metabolic dysfunction-associated steatohepatitis (MASH). In prior clinical trials, pemvidutide...
Evaluation of the Dissolution Behavior of the Lysosomotropic Drug Amlodipine using Physiologically Based Biopharmaceutics Modeling (PBBM)
Amlodipine (AML) is a weak base drug (pKa 9.1, lop=2.96) belonging to class I of the BCS and therefore a candidate for biowaiver.
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].