What you should know about FDA Project Optimus for your oncology drug approval
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…
Danielle Pillsbury2023 年 3 月 10 日
RAPS Sponsored Webcast: Oops, I messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes
Oops, I made a mistake! Everyone has made or seen one, and sometimes it is…
Danielle Pillsbury2023 年 3 月 9 日
Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types
Simcyp Simulator has been utilized to inform more than 300 label claims for 90+ novel…
Danielle Pillsbury2023 年 3 月 7 日
GlobalSubmit™ eCTD Platform
GlobalSubmit enables teams to simplify the eCTD submission process to successfully publish, validate, and review…
Danielle Pillsbury2023 年 3 月 3 日
Drug Development Considerations for Live Biotherapeutic Products
A new class of complex biologics has emerged in recent years. These are classified in…
Danielle Pillsbury2023 年 3 月 3 日
Agent-Based Model Predicts Impact of Monoclonal Antibody Treatment, Prophylaxis & Vaccines on Viral Transmission during Pandemic
Agent-based models focus on the heterogeneous behavior of individual agents and their interactions with one…
Danielle Pillsbury2023 年 3 月 2 日
Learn how to create CDISC domains in minutes with PK Submit
Creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions can be…
Danielle Pillsbury2023 年 3 月 1 日
Understanding Europe’s New Clinical Trial Regulations (EU-CTR)
While the new EU-CTR will help to streamline clinical trials, which will benefit both patients…
Danielle Pillsbury2023 年 2 月 27 日
