增强药物开发的确定性

Physiologically Based Pharmacokinetic (PBPK) modelling is an integrative approach facilitating the optimal use of various in vitro and preclinical data to determine the first in human dose.&nbsp;&nbsp; Simcyp Discovery, a part of Simcyp family, is a user-friendly PBPK platform designed to integrate in vitro and preclinical data, enabling the prediction of drug pharmacokinetics (PK) in &hellip; <a href="https://www.certara.com.cn/webinar/physiologically-based-pharmacokinetic-modelling-an-integrative-approach-to-first-in-human-fih-studies-apac-webinar/">Continued</a>

欢迎参加 Phoenix Cloud 即将推出的表格、数字和列表 (TFL) 模块独家抢先体验。Discover how this innovative tool will revolutionize the way you create and manage TFLs, providing faster results, enhanced flexibility, and streamlined collaboration.&nbsp; During this webinar, you’ll explore key features such as:&nbsp; This webinar is perfect for &hellip; <a href="https://www.certara.com.cn/webinar/sneak-preview-introducing-the-new-tfl-module-in-phoenix-cloud/">Continued</a>

What is a “cell therapy”? Nearly every recent oncology clinical conference has featured this phrase. Cell therapies, such as CAR-Ts (chimeric antigen receptor T-cells), aren’t small molecule drugs or simple biologics. They’re a whole new class of therapeutics! How does CAR-T technology work? In simple terms, it’s a method for enabling our immune system to … Continued

The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for exchanging nonclinical drug development data. SEND was developed by the Clinical Data Interchange Standards Consortium (CDISC), a globally recognized, not-for-profit organization that develops data standards with the input of pharmaceutical industry experts. The U.S. Food and Drug Administration (FDA) requires drug … Continued

In drug development, early strategic planning is crucial to minimizing risks, optimizing formulations, and setting up candidates for success. In a recent presentation given at the 2024 AAPS PharmSci 360 Conference, Certara’s Deven Shah, Head of CMC, and David B. Turner, Senior Scientific Advisor & Head of Mechanistic Oral Absorption Modelling, shared insights into using … Continued