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…
CertaraJuly 28, 2023
ICER’s Unsupported Price Increase Report: Unfit for Policymaking
Since 2019, the Institute for Clinical and Economic Review (ICER) has published an annual Unsupported…
CertaraJuly 25, 2023
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…
CertaraJuly 21, 2023
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…
CertaraJuly 21, 2023
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…
CertaraJuly 20, 2023
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…
CertaraJuly 14, 2023
Certara to Report Second Quarter 2023 Financial Results on August 9th, 2023
PRINCETON, N.J.— July 13, 2023-- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today…
CertaraJuly 13, 2023
AAPS eChalk talk: FDA Modernization Act – What Does it Mean for Pharmaceutical Scientists?
Historically, the FDA has required drug discovery and development programs to include animal testing. With the…
CertaraJuly 12, 2023
