DIA Annual Meeting 2025 Blog Post
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Data Visualization with SEND Data to See What Happened at the Preclinical Phase Blog Post
SEND is an implementation of CDISC’s (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation Model) for nonclinical studies. SEND specifies a standard format for presenting nonclinical study data in…
インフレーション抑制法（Inflation Reduction Act）は医薬品開発の意思決定に影響を及ぼすか Blog Post
The short answer is yes. In fact, passage of the Inflation Reduction Act (H.R. 5376) has already impacted at least one company’s drug development plans based on a recent press…
Physiologically-Based Pharmacokinetic Modeling & Simulation to Support Asciminib NDA Submission & Inform Drug Product Label Blog Post
Physiologically based pharmacokinetic (PBPK) modeling and simulation has become an established approach to assess drug-drug interaction (DDI) liabilities involving CYP enzymes, with transporters and/or absorption-related mechanisms evolving in its acceptance…
Ghent University wins the 2021/22 Certara-Simcyp Grant and Partnership Scheme Blog Post
PRINCETON, N.J., 2023年1月9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 announced that Ghent University (Belgium) submitted the successful bid for the 2021/22 Grant and…
Project Optimus: How to Prepare for Success Blog Post
For some time now, cancer drug developers have known “Project Optimus” and new dose optimization expectations are coming their way from the Food and Drug Administration’s (FDA) Oncology Center of…
Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy Blog Post
Olanzapine is an effective antipsychotic medication used to treat schizophrenia, a disease that affects about 1 in 300 people worldwide.1 However, side effects such as weight gain can cause patients...
Why you should select your drug formulation before starting clinical studies Blog Post
創薬企業はしばしば、ヒトでの試験を急ぐあまり、創薬プロセスを駆け足で進めてしまうことがあります。Most are so curious about their new target or molecule that they may forget that the pharmaceutical…
