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
Pediatric Drug Development: Optimizing Extrapolation
Drug development in pediatrics continues to be a substrate for the application of innovative tools…
Certara2021 年 9 月 1 日
Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations
The era of gene therapy may have started a couple of decades ago, but approvals…
Certara2021 年 8 月 13 日
Succeeding in Value Communication: Introduction
Drawn from the experiences of the BaseCase Consulting Team, this is the introduction to ‘Succeeding…
Certara2021 年 8 月 5 日
