What if we could reduce the size of a phase III study from 400 to 80 subjects and make it twice as short? Thanks to model-informed clinical trial design, it's possible!
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
Fremanezumab, a fully humanized IgG2Δa/kappa monoclonal antibody, selectively targets the calcitonin-gene-related peptide (CGRP) and
Pulmonary PBPK Modeling for Inhaled Products: Antibiotic Case Studies
What are we doing for inhaled products today?
NAFLDsym Application Showcase: Key Examples of NAFLDsym Use within Drug Development
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
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
For treatment of chronic cancers, the oral administration route is preferred as it provides numerous advantages over other delivery routes.
Simulations Plus Uplisted to The Nasdaq Global Select Market®
Strong growth, innovation, and global reach drive the company’s progress
May 2021 GastroPlus Newsletter
We hope that you and yours are coming out of our Covid enforced isolation.
Evaluating the Hepatotoxicity of Compound V with QST/QSP Modeling
Is your compound causing drug-induced liver injury?
May 2021 News/Events
Did you know? We provide high-quality analysis & support services including non-compartmental PK analysis, population PK and PK/PD modeling, PBPK modeling in GastroPlus®, and statistical modeling, focusing on...
Applications of Pharmacometrics in Phase 1 Studies
Phase 1 is a drug development stage where you start the clinical evaluation of the drug.
Pharmacokinetic/pharmacodynamic modeling of drug interactions at the P2Y12 receptor between selatogrel and oral P2Y12 antagonists
Selatogrel is a potent and reversible P2Y12 receptor antagonist developed for subcutaneous self‐administration by patients with suspected acute myocardial infarction.
DILIsym® Applications in Drug Development – Perspectives from 2 Pharma Industry Executives & an Experienced Consultant
What do NURTEC™ ODT, TURALIO®, lixivaptan, solithromycin, JYNARQUE®, VEKLURI®, and UBRELVY® have in common?
Modeling and Simulation of a parent-metabolite-PD datatset (Spring School challenge solution)
Whether you have participated to our Spring School and its modeling challenge or not, this webinar is for you!
Human-on-a-Chip combined with PBPK modeling for in vitro/in vivo PK/PD extrapolation
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.
Scaffold-Hopping Strategy on a Series of Proteasome Inhibitors Led to a Preclinical Candidate for the Treatment of Visceral Leishmaniasis
There is an urgent need for new treatments for visceral leishmaniasis (VL), a parasitic infection which impacts heavily large areas of East Africa, Asia, and South America