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...
米国FDAが主導する「プロジェクト・オプティマス」とは？
がん治療薬開発にどのような影響を与えるのか？ Blog Post
プロジェクト・オプティマス (Project Optimus)は、米国食品医薬品局（米国FDA）のOncology Center of Excellence（OCE）によって提言された新たな取り組みです。この提言では、がん治療薬の開発企業に対して開発中により幅広い用量に対する有効性を評価させ、ピボタル試験の用量設定に最大耐量（MTD）を用いるアプローチからの脱却を促しています。... 
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus Blog Post
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。This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely…
