Leveraging Clinical Data from One Rare Disease to Support Drug Approval for Another
Atypical hemolytic uremic syndrome (aHUS) is an ultra-rare genetic disease that causes abnormal blood clot…
Certara2022 年 6 月 1 日
Choosing an eCTD Submissions Vendor: Your Complete Checklist
2025 年 9 月 3 日 Selecting the right electronic submission vendor for regulatory submissions to health authorities…
Certara2022 年 1 月 28 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
Dose Optimization Using Population PK for an Orphan Drug
RAPALIMUS® Tablets (sirolimus) is Nobelpharma’s orphan drug developed from an oral medication that is sold…
Certara2021 年 11 月 17 日
Defining path-to-market strategy through a data-driven and scientific approach
How Certara supported a gene therapy manufacturer by using a selection of gateway and value…
Certara2021 年 10 月 28 日
The Scary Future of Rare Disease Management
In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…
Certara2021 年 9 月 23 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
