Development and In Vitro Evaluation of Controlled Release Viagra® Containing Poloxamer-188 Using Gastroplus™ PBPK Modeling Software for In Vivo Predictions and Pharmacokinetic Assessments

Development and In Vitro Evaluation of Controlled Release Viagra® Containing Poloxamer-188 Using Gastroplus™ PBPK Modeling Software for In Vivo Predictions and Pharmacokinetic Assessments

Authors: Arafat M, Sarfraz M, AbuRuz S
Publication: Pharmaceuticals
Keywords: dissolution specifications, extended release, formulation design, gastroplus, mechanistic absorption, PBPK modeling, physiologically based biopharmaceutics modeling
Software: GastroPlus®

Sildenafil is the active substance in Viagra® tablets, which is approved by the FDA to treat sexual dysfunction in men. Poor solubility and short half-life, however, can limit the span of its effectiveness.

Scaling Approaches for Pediatric Dose Selection: the Fremanezumab (AJOVY®) Journey to Select a Phase 3 Dose Using Pharmacokinetic Data From a Phase 1 Study. Pharmaceuticals

Scaling Approaches for Pediatric Dose Selection: the Fremanezumab (AJOVY®) Journey to Select a Phase 3 Dose Using Pharmacokinetic Data From a Phase 1 Study. Pharmaceuticals

Authors: Jones A, Cohen-Barak O, Radivojevic A, Fiedler-Kelly J
Publication: Pharmaceutics
Keywords: fremanezumab, pediatric dose selection, pediatric migraine, pharmacometrics
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Fremanezumab, a fully humanized IgG2Δa/kappa monoclonal antibody, selectively targets the calcitonin-gene-related peptide (CGRP) and

NAFLDsym Application Showcase: Key Examples of NAFLDsym Use within Drug Development

NAFLDsym Application Showcase: Key Examples of NAFLDsym Use within Drug Development

Authors: Siler SQ, Battista C, Kenz Z
Keywords: drug development, NAFLDsym, NASH, Non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), qsp, QST
Software: NAFLDsym®
Division: Quantitative Systems Pharmacology (QSP)

NAFLDsym is a quantitative systems pharmacology (QSP) modeling software to support the development of treatments for non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).

Using Quantitative Systems Pharmacology Modeling to Understand the Pathophysiology of Idiopathic Pulmonary Fibrosis

Using Quantitative Systems Pharmacology Modeling to Understand the Pathophysiology of Idiopathic Pulmonary Fibrosis

Authors: Siler SQ, Longo DM, Woodhead JL, Battista C, Kenz Z, Tallapaka SB, Liu G, Generaux GT, Ermakov S, Shoda LKM
Conference: American Thoracic Society (ATS) International Congress
Keywords: epithelial cell health, fibroblasts, IPFsym, nintedanib, pulmonary playlist, quantitative systems pharmacology (QSP), SimPops
Software: IPFsym®
Division: Quantitative Systems Pharmacology (QSP)

Patients with idiopathic pulmonary fibrosis (IPF) have a poor survival prognosis and limited treatment options.

Administration in fed state but not controlled release in the colon increases oral bioavailability of DF030263, a promising drug candidate for chronic lymphocytic leukemia

Administration in fed state but not controlled release in the colon increases oral bioavailability of DF030263, a promising drug candidate for chronic lymphocytic leukemia

Authors: Lee JB, Zang X, Zgair A, Ooi TQ, Foley DW, Voronin G, Kagan L, Soukarieh F, Gao R, Shao H, Soh WT, Kim TH, Kim MG, Yun HY, Wilson AJ, Fischer PM, Gershkovich P
Publication: Eur J Pharm Biopharm
Keywords: colonic absorption, extended release, food effect, gastroplus, mechanistic absorption, pbbm, PBPK modeling, physiologically based biopharmaceutics modeling
Software: GastroPlus®

For treatment of chronic cancers, the oral administration route is preferred as it provides numerous advantages over other delivery routes.

Pharmacokinetic/pharmacodynamic modeling of drug interactions at the P2Y12 receptor between selatogrel and oral P2Y12 antagonists

Pharmacokinetic/pharmacodynamic modeling of drug interactions at the P2Y12 receptor between selatogrel and oral P2Y12 antagonists

Authors: Henrich A, Claussen CH, Dingemanse J, Krause A
Publication: CPT Pharmacometrics Syst Pharmacol
Keywords: P2Y12 receptor antagonists, pharmacodynamics, pharmacokinetics (PK)

Selatogrel is a potent and reversible P2Y12 receptor antagonist developed for subcutaneous self‐administration by patients with suspected acute myocardial infarction.

Human-on-a-Chip combined with PBPK modeling for in vitro/in vivo PK/PD extrapolation

Human-on-a-Chip combined with PBPK modeling for in vitro/in vivo PK/PD extrapolation

Authors: Hickman J, Lukacova V
Keywords: drug-drug interactions (DDIs), gastroplus, Human-on-a-Chip (HoaC) systems, in vitro, PK prediction
Software: GastroPlus®
Division: PBPK

Human-on-a-Chip (HoaC) systems are becoming valuable tools to study, understand disease physiology, and expand the prediction of pharmacodynamic effects before first-in-human studies. They can also be used to evaluate the toxic effects of compounds in non-pharma industries where these effects cannot be examined in vivo.