Improved Workflow and Expanded functionality of RsNLME v1.1
R Speaks NLME (RsNLME) is a collection of R packages and companion RShiny apps that…
Jim Gallagher2022 年 1 月 31 日
Choosing an eCTD Submissions Vendor: Your Complete Checklist
Selecting the right electronic submission services vendor for your organization’s regulatory submissions to health authorities…
Jim Gallagher2022 年 1 月 28 日
Don’t Forget About Safety! How to Assess Drug Candidate Safety in Early Clinical Development
This blog will reflect on 3 things drug developers should pay attention to regarding safety…
Jim Gallagher2022 年 1 月 24 日
Certara’s Simcyp Simulator Demo
The Simcyp PBPK Simulator is the industry leader and most widely adopted platform for PBPK…
Jim Gallagher2022 年 1 月 20 日
R Speaks NLME (RsNLME)
This recording shows an overall review of RsNLME using Pirana and an extensive explanation on…
Jim Gallagher2022 年 1 月 19 日
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus
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…
Jim Gallagher2022 年 1 月 13 日
PBPK Modeling of Antibody-Drug Conjugates – Concept and Application
Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a…
Jim Gallagher2022 年 1 月 13 日
我何时应该选择 eCTD 供应商来进行我的监管申报？
As your company moves towards the regulatory submission of a marketing application to a health…
Jim Gallagher2022 年 1 月 10 日
Certara University Express Webinar: Part 2: Introduction to RsNLME and overview of expanded workflow
Introduction to RsNLME and its capabilities for population PK/PD modeling.
Jim Gallagher2022 年 1 月 5 日
