Certara Releases Version 20 of Simcyp
Certara, Inc. announced the release of version 20 of its Simcyp Physiologically-based Pharmacokinetic (PBPK) Simulator platform. Simcyp PBPK Simulator version 20 provides new models for maternal health, virtual bioequivalence to attain biowaivers, and analysis of long-acting injectable drugs.
The Simcyp PBPK Simulator’s in silico models have informed the label claims of more than 75 novel FDA-approved drugs. Simcyp PBPK Simulator version 20 offers models for maternal health, such as assessing drug performance during pregnancy and lactation.
Simcyp PBPK Simulator version 20 offers models for maternal health, such as assessing drug performance during pregnancy and lactation. It also automates the assessment of virtual bioequivalence to attain biowaivers and analyzes drugs delivered via long-acting injectable delivery. Additional upgrades have been made to the Simcyp PBPK Simulator’s animal, liver, absorption, and skin models.
For more information, click here.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
