一直以来，肿瘤药物的剂量策略都以最大耐受剂量为重点。这导致药物的药代动力学（PK）特征、药代动力学/药效学（PK/PD）关系以及临床靶点抑制作用在很大程度上被忽视。Thus, cancer patients often struggle to tolerate their medication doses long-term, requiring dose modifications including dose reductions and holidays. What’s more, for many … Continued
https://www.certara.com.cn/on-demand-webinar/what-you-should-know-about-fda-project-optimus-for-your-oncology-drug-approval/Historically, the FDA has required drug discovery and development programs to include animal testing. This requirement has ended with the 2022 passage of the FDA Modernization Act. This change has opened the door for expanded use of alternatives to animal testing including biosimulation, organ-on-a-chip, and cell based assays. In this panel discussion with Nasdaq’s David … Continued
https://www.certara.com.cn/on-demand-webinar/fda-modernization-act-2-0-what-does-it-mean-for-drug-developers/Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator is being used to verify and expand biosimulation models for assessing virtual bioequivalence (VBE) of complex generic drugs PRINCETON, N.J.— 2023 年 2 月 7 日. Certara (Nasdaq: CERT), a global leader in biosimulation, today announced the Company has been awarded work with the University of Florida and the University of Rhode … Continued
https://www.certara.com.cn/announcement/fda-awards-new-grants-to-support-developing-assessing-complex-generic-drugs/The effects of drug-drug interactions (DDIs) could differ in the pediatric population compared to adults. The resulting changes in exposure of the victim drug, because of a DDI, at a metabolism and/or transport level could be larger or smaller, depending on the relative contribution of the affected enzyme/transporter to the disposition of the drug in … Continued
https://www.certara.com.cn/blog/new-fda-requirement-to-support-labeling-on-ddis-in-the-pediatric-population/Is there a better way? The question always breeds critical thinking and often leads to new solutions. In this discussion, it can entirely rewrite the approach to, and relieve many of, the common pitfalls experienced during…
https://www.certara.com.cn/article/achieving-simultaneous-new-drug-documentsubmission-for-the-fda-and-ema/In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance [1]. This is a welcome addition and clarifies the position of the agency on some key aspects regarding development of oligonucleotide therapies. Whilst the guidance still leaves a few open questions, it provides drug developers with a starting point and acknowledges that … Continued
https://www.certara.com.cn/blog/3-takeaways-from-fda-oligo-guidance/The FDA-ASCO (American Society of Clinical Oncology) workshop on oncology dose optimization (3-5 May 2022) provided the most in-depth view to date into the FDA’s thinking regarding the Oncology Center of Excellence (OCE) led Project Optimus and the shifting paradigm of dose optimization in oncology. Below are a few key take-aways from this meeting: Project … Continued
https://www.certara.com.cn/blog/fda-asco-workshop-oncology-drugs-dose-optimization/2022 is shaping up to be the “year of the guidance” as the FDA has just released a new guidance on using circulating tumor DNA in early clinical drug development. 在这篇博客中，我将思考为什么说这个机构的指南对新的肿瘤治疗是如此重要。Despite many important advances in oncology drug … Continued
https://www.certara.com.cn/blog/why-fdas-new-guidance-on-circulating-tumor-dna-is-critical-for-oncology-early-clinical-drug-development/Join us for this SPECIAL SESSION taking place during DIA Global 2022. This is a cocktail reception with presentation and Q&A hosted by Julie Bullock, PharmD & ex FDA and Demetrius Carter at the Hyatt Regency McCormick Place. Given the launch of Project Optimus, how do you best navigate the evolving regulatory landscape and determine … Continued
https://www.certara.com.cn/conference/dia-optimus/In partnership with RAPS this webinar provided an overview of FDA’s Project Optimus and its potential impacts on oncology drug development. The historical 3×3 Phase 1 study design to establish a Maximum Tolerated Dose (MTD) was developed for cytotoxic agents (eg, platins). Now, most new agents are immunotherapies and other biologics for which a more … Continued
https://www.certara.com.cn/on-demand-webinar/what-is-fdas-project-optimus-and-how-will-it-impact-oncology-drug-development/
