Make informed decisions with real-time SDTM compliant data How about a demo of Pinnacle 21 Clinical Data Management & Automation Suite? Complete the form to book your no-obligation demo of…
The bioequivalence (BE) test is a test in which the manufacturer compares the bioavailability of other same-component drugs, and if certain criteria are met, it is judged that “biologically equivalent”…
We explore progressive uses of Define-XML in trials, and why you should design submission datasets upfront, with define.xml file & SDTM in mind.
Over the last decade, our industry has become familiar with Clinical Data Interchange Standards Consortium (CDISC) standards. This has largely been driven by regulation, with national regulators such as FDA…
Learn how innovative clinical trial technology helps to revolutionize research & ensure the swift rollout of safe and effective treatments.
The pre-competitive scientific research consortium of top pharmaceutical companies remains a critical force in advancing qualified PBPK modeling and simulation to further drug development and regulatory decisions RADNOR, PA –…
これまで、がんやその他の進行が速く致死的な疾患に対する薬剤開発プログラムでは、臨床薬理パッケージにマスバランス試験が含まれていないことが一般的でした。This omission stems from the ICH S9 on nonclinical evaluation…
© 2025 Certara. All Rights Reserved. | 個人情報保護
