歴史的に、がん治療薬の投与戦略は最大耐容量に焦点が当てられてきました。そのため、薬剤の薬物動態（PK）プロファイル、薬物動態/薬力学（PK/PD）関係、臨床標的の阻害などがほとんど無視された状態になっています。そのため、がん患者は長期間の薬物投与に耐えられないことが多く、減量や休薬などの用量変更を余儀なくされています。What’s more, for many … Continued
https://www.certara.com/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/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/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/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/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/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/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. In this blog, I will reflect on why this agency guidance is so important for new oncology therapeutics. Despite many important advances in oncology drug … Continued
https://www.certara.com/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/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/on-demand-webinar/what-is-fdas-project-optimus-and-how-will-it-impact-oncology-drug-development/
