Certaraは、6年連続して、90パーセント以上の米国FDAによる新薬の承認をサポート
PRINCETON, NJ – Jan. 23, 2020 – Certara today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2019 were supported by Certara software or services.
Author: webdev
Visualization of Complex Trial Data in Non-Linear Mixed-Effect Analyses With Covariates
Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110
Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing
Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing
Certara 2019年のベストブログ
A selection of short essays from our blog, written to empower our clients with modeling and simulation (M&S), regulatory science, and real-world value assessment solutions to help them solve the toughest drug development problems. In the Best of the Blog, Certara’s scientists and regulatory experts share their learnings, technological advances, and thought leadership.
Certaraは、Galderma社とのパートナーシップの下、局所アクネクリームであるAKLIEF®の米国FDA承認を取得
PRINCETON, NJ – Jan. 8, 2020 – Certara’s Simcyp® Simulator’s MechDermA™ model provided safety label claim and pediatric dosing information without the need for testing in clinical patients for a topical drug product.
Updates to the Simcyp Simulator’s Oral Absorption ADAM and M-ADAM Models
This webinar provided an update on the extensive recent additions to the mechanistic models for handling oral dosage forms available within the ADAM/M-ADAM framework.
LEO Pharma Joins Certara’s PBPK Simcyp Simulator Consortium
PRINCETON, NJ – Dec. 10, 2019 – LEO Pharma has licensed Certara’s proprietary Simcyp®️ Population-based Simulator and joined its Consortium.
Effectively Developing Cutting-edge Mobile Tools for Market Access
This webinar explained how to conceptualize, optimize, and kick-off your mobile tool development process.
What’s New in the Simcyp Simulator v19?
This webinar explained how the latest updates in the Simcyp Simulator v19, Certara’s physiologically-based pharmacokinetic (PBPK) modeling and simulation platform, will support developing safer, more effective medications faster.
