Design and Evaluation of 3-Phenyloxetane Derivative Agonists of the Glucagon-Like Peptide-1 Receptor

Design and Evaluation of 3-Phenyloxetane Derivative Agonists of the Glucagon-Like Peptide-1 Receptor

Publication: J Med Chem
Software: GastroPlus®
Division: PBPK

Various small molecule GLP1R agonists have been developed and tested for treating type 2 diabetes (T2DM) and obesity.

Targeting Complement to Reduce Disease Activity: Challenges and Opportunities in the Publicly Available Data (Part Two)

Targeting Complement to Reduce Disease Activity: Challenges and Opportunities in the Publicly Available Data (Part Two)

Authors: Shoda L, Kenz Z, Clemens L

In part one of this complement blog series, the complement cascade and its role in various diseases was introduced, as well as the potential for mechanistic modeling to support development of complement‑targeted therapeutics. COMPLEMENTsym, a quantitative systems pharmacology (QSP) model of complement focused on the alternative and terminal pathways (AP, TP, respectively) was introduced.

Comparison of drug-induced liver injury risk between propylthiouracil and methimazole: A quantitative systems toxicology approach

Comparison of drug-induced liver injury risk between propylthiouracil and methimazole: A quantitative systems toxicology approach

Publication: Toxicol Appl Pharmacol
Software: DILIsym®

Propylthiouracil (PTU) and methimazole (MMI), two classical antithyroid agents possess risk of drug-induced liver injury (DILI) with unknown mechanism of action.

Redefining Statin Dosage Post-Gastric Bypass: Insights from a Population Pharmacokinetics–Pharmacodynamics Link Approach

Redefining Statin Dosage Post-Gastric Bypass: Insights from a Population Pharmacokinetics–Pharmacodynamics Link Approach

Publication: Journal of Clinical Pharmacology
Software: Monolix®

Roux-en-Y gastric bypass (RYGB) involves creating a small stomach pouch, bypassing part of the small intestine, and rerouting the digestive tract.

Scaling approaches for the prediction of human clearance of LNA-i-mir-221: A retrospective validation

Scaling approaches for the prediction of human clearance of LNA-i-mir-221: A retrospective validation

Publication: Curr Res Pharmacol Drug Discov
Software: Monolix®

LNA-i-miR-221 is a novel microRNA(miRNA)-221 inhibitor designed for the treatment of human malignancies.

Computational approach for drug discovery against Gardnerella vaginalis in quest for safer and effective treatments for bacterial vaginosis

Computational approach for drug discovery against Gardnerella vaginalis in quest for safer and effective treatments for bacterial vaginosis

Publication: Scientific Reports
Software: GastroPlus®
Division: PBPK

Bacterial vaginosis (BV), primarily attributed to Gardnerella vaginalis, poses significant challenges due to antibiotic resistance and suboptimal treatment outcomes.

Development and Application of a Physiologically Based Pharmacokinetic Model for Elagolix in the Adult and Adolescent Population

Development and Application of a Physiologically Based Pharmacokinetic Model for Elagolix in the Adult and Adolescent Population

Publication: Clin Pharmacokinet
Software: GastroPlus®
Division: PBPK

Endometriosis, a common and distressing gynecological condition, affects fertility and causes pain, is often managed with medications such as Elagolix.

Cellulose ether and carbopol 971 based gastroretentive controlled release formulation design, optimization and physiologically based pharmacokinetic modeling of ondansetron hydrochloride minitablets

Cellulose ether and carbopol 971 based gastroretentive controlled release formulation design, optimization and physiologically based pharmacokinetic modeling of ondansetron hydrochloride minitablets

Publication: Int J Biol Macromol
Software: GastroPlus®
Division: PBPK

This study aims to design and optimize ondansetron (OND) gastro-retentive floating minitablets for better and prolonged control of postoperative nausea and vomiting (PONV) with improved patient compliance.

Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling

Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling

Publication: AAPS J
Software: GastroPlus®
Division: PBPK

Currently, Biopharmaceutics Classification System (BCS) classes I and III are the only biological exemptions of immediate-release solid oral dosage forms eligible for regulatory approval.