How Can Model-Informed Drug Development Accelerate Your Program?
What is model-informed drug development (MIDD), and why is it so critical to informing the…
Certara2023年7月28日
ICER’s Unsupported Price Increase Report: Unfit for Policymaking
Since 2019, the Institute for Clinical and Economic Review (ICER) has published an annual Unsupported…
Certara2023年7月25日
Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling
While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration…
Certara2023年7月21日
Simcyp™ Compound Summaries Library: What is it & why should you use it?
In the world of pharmacokinetic/dynamic (PBPK/PD) modelling, compound PBPK models are incorporated into compound files…
Certara2023年7月21日
RAPS Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission
In September 2023, the European Medicines Agency (EMA) will reinstate their Policy 0070 requirement to…
Certara2023年7月20日
Change Management – An Important Part of Good Manufacturing Practice (GMP)
You are having a good day as a quality assurance professional at a small pharmaceutical…
Certara2023年7月14日
Certara to Report Second Quarter 2023 Financial Results on August 9th, 2023
PRINCETON, N.J.— 2023年7月13日-- Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in biosimulation, today…
Certara2023年7月13日
AAPS eChalk talk: FDA Modernization Act – What Does it Mean for Pharmaceutical Scientists?
歴史的に、FDAは薬剤発見および開発プログラムに動物実験を含めることを要求してきました。With the…
Certara2023年7月12日
