グローバルガイドラインに沿って前臨床試験データ管理を最適化するのに役立つソフトウェアの導入Seoul, SOUTH KOREA August 4rd – 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…
The prevalence of diabetes in the US is incredibly high and affects more than 10% of the population. Patients living with diabetes rely on insulin to manage their blood sugar…
DNDi Utilizing Pinnacle 21 Enterprise (P21E), Certara’s Data Science platform for Biostatistics, Data Management, and Data Standards to Streamline Clinical Data Flow PRINCETON, NJ/NAIROBI, KE, 2023年7月31日 – Certara,…
Since 2019, the Institute for Clinical and Economic Review (ICER) has published an annual Unsupported Price Increase (UPI) Report on its “assessment on drugs that experience significant price hikes without…
While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration of pre-existing data on systems and drugs is growing from its infancy, building confidence on…
In the world of pharmacokinetic/dynamic (PBPK/PD) modelling, compound PBPK models are incorporated into compound files that serve as a vital component for accurate predictions for virtual clinical trials. Version 22…
In September 2023, the European Medicines Agency (EMA) will reinstate their Policy 0070 requirement to publish all clinical studies submitted to the EMA for regulatory approval. After almost five years…
You are having a good day as a quality assurance professional at a small pharmaceutical company until you open an email from your company president asking for an explanation. She…
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 announced that it will release financial results for the second quarter of 2023 after the…
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 2022 passage of the FDA Modernization Act 2.0, the definition of “nonclinical tests” conducted to support pharmaceutical…
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