How to Fix Your Biggest Bioequivalence Mistakes Blog Post
生物等效性是生物药剂学中普遍被误解的术语。需要明确的是，生物等效性是根植于法规的技术概念。The Code of Federal Regulations (CFR) Subchapter D deals with drugs for…
New PMDA Validation Rules 3.0 Explained Blog Post
In this blog, we explore what you need to know about the update to the new PMDA Validation Rules for SDTM, ADAM and Define-XML.
Experts Unravel the Top 5 Myths Related to Bioequivalence Blog Post
生物等效性通过药代动力学桥接口服药物剂型的安全性与有效性，The concepts behind bioequivalence are technical and cross-functional in nature (a collaboration between biopharmaceutics and pharmaceutical sciences)….
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...
The Challenging Road to Developing an Integrated Platform for Drug Discovery and Precision Medicine Using the Power of Pharmacometrics Blog Post
We have often seen Dr. Hwi-yeol (Thomas) Yun, Associate Professor/Adjunct Professor at the College of Pharmacy and Bio-AI Convergence Research Center of Chungnam National University, listed as a guest presenter…
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。...
Choosing an eCTD Submissions Vendor: Your Complete Checklist Blog Post
Selecting the right electronic submission services vendor for your organization’s regulatory submissions to health authorities for the approval of new drugs or biologics is a critical decision. The vendor selection…
