Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease
全世界约有 400,000 名先天性肾上腺增生症（CAH）患者。Current therapy for CAH uses a…
Certara2022 年 6 月 6 日
PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA
In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to…
Certara2022 年 6 月 2 日
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
PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials
Genentech was developing polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) to…
Certara2022 年 4 月 11 日
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
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…
Certara2022 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…
Certara2022 年 1 月 13 日
ScienceDirect: Effect of early treatment with metformin on risk of emergency care and hospitalization among patients with COVID-19: The TOGETHER randomized platform clinical trial
Observational studies have postulated a therapeutic role of metformin in treating COVID-19. We conducted ...(cont.)
Certara2021 年 12 月 22 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
