New FDA Validator Rules V1.6 Explained Blog Post
In this blog, we explore what you need to know about the update to the new FDA Validator Rules V1.6 & answer key questions about the changes.
New FDA Requirement to Support Labeling on DDIs in the Pediatric Population Blog Post
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…
Simultaneous FDA & EMA Submissions for Drug Approvals Blog Post
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…
3 Takeaways from the FDA Oligo Guidance You Need to Know Blog Post
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…
Highlights from the FDA-ASCO Workshop on Dose Optimization for Oncology Drugs Blog Post
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…
Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development Blog Post
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….
eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus Blog Post
Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target…
FDA Project Optimus Page
Optimizing Oncology Drug Development with FDA Project Optimus Ensure smarter dosing and regulatory success Learn more about Project Optimus Learn more Navigate dose optimization with Certara The FDA's Project Optimus...
什么是 FDA Project Optimus？它会如何影响肿瘤药物开发？ Blog Post
Project Optimus 是美国食品药品监督管理局肿瘤卓越中心(OCE)提出的一项计划，该计划在评估开发药物不同剂量的有效性方面向癌症药物生产商提出了新的要求，同时要求从使用最大耐受剂量(MTD)法转变为确定关键临床研究的剂量。...
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus Blog Post
一直以来，肿瘤药物的剂量策略都以最大耐受剂量为重点。This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely…
