Greater Certainty in Drug Development

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/webinar/physiologically-based-pharmacokinetic-modelling-an-integrative-approach-to-first-in-human-fih-studies-apac-webinar/">Continued</a>

Join us for an exclusive sneak preview of the upcoming Tables, Figures, and Listings (TFL) Module in Phoenix Cloud. 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/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