什么是 FDA Project Optimus？它会如何影响肿瘤药物开发？
Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…
Certara2022 年 2 月 2 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…
Certara2022 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…
Certara2022 年 1 月 24 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…
Certara2022 年 1 月 10 日
A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease
New therapeutics discovery and development for ocular diseases have been traditionally associated with a low…
Certara2021 年 12 月 15 日
Industry Metrics for CDISC Controlled Terminology
Sergiy Sirichenko summarizes industry metrics across many studies and sponsors to produce an overall picture…
Certara2021 年 11 月 17 日
Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations
Traditional mechanisms of drug action rely on the reversible, noncovalent interaction of a ligand with…
Certara2021 年 11 月 5 日
Accelerating ADCs’ development pipeline using Simcyp PBPK
With nearly 10 million deaths in 2020 and despite great progress, cancer remains the leading…
Certara2021 年 10 月 15 日
A Day in the Life of a Clinical Pharmacology Consultant
Strategic consulting within drug discovery and development is an exciting career choice for many. Unlike…
Certara2021 年 10 月 8 日
Building a Robust Clinical Pharmacology & Model-Informed Drug Development Strategy for New Alzheimer’s Disease Drugs
Alzheimer's disease (AD) is one of the most common forms of neurodegenerative dementia in the…
Certara2021 年 9 月 20 日
