Greater Certainty in Drug Development

Join us on December 5th at 11:00 AM ET for an exclusive webinar, &#8220;New Horizons of Model-Informed Drug Development in Rare Diseases,&#8221; hosted in partnership with Takeda and Kura Oncology. Model-informed drug development is revolutionizing the way we approach rare diseases, where traditional large-scale clinical trials may be impractical or even unethical. By integrating nonclinical &hellip; <a href="https://www.certara.com/webinar/unlock-the-future-of-rare-diseases-drug-development/">Continued</a>

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>

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

Once upon a time, regulatory writing for drug development programs followed a scheduled routine and involved clearly defined roles. The writers wrote all the non-clinical and clinical documentation, and then the reviewers reviewed it.  With the advent of collaborative authoring technology, that process went by the wayside. Initial drafts are frequently written in collaboration with team … Continued