Therapeutic Specialties Archives

Case Study

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…

Becca Bucci2022 年 6 月 2 日

Case Study

利用一种罕见病的临床数据支持另一种罕见病的药物审批

Atypical hemolytic uremic syndrome (aHUS) is an ultra-rare genetic disease that causes abnormal blood clot…

Becca Bucci2022 年 6 月 1 日

Case Study

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…

Jim Gallagher2022 年 4 月 11 日

博客

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…

Jim Gallagher2022 年 2 月 2 日

On-Demand Webinar

肿瘤药物开发人员应该从 FDA Project Optimus 中期待获得什么？

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

On-Demand Webinar

抗体-药物偶联物的 PBPK 模型 — 概念和应用

Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a…

Jim Gallagher2022 年 1 月 13 日

Publication

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.)

Jim Gallagher2021 年 12 月 22 日

Blog

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…

Jim Gallagher2021 年 12 月 15 日

Blog

开发靶向共价抑制剂药物：3关键考虑因素

Traditional mechanisms of drug action rely on the reversible, noncovalent interaction of a ligand with…

Jim Gallagher2021 年 11 月 5 日

Press Release

Certara Simcyp™ 新冠肺炎疫苗模型获R&D 100 奖

Biosimulation tool to conduct ‘what-if’ scenarios with virtual patients recognized in Software/Services category PRINCETON, NJ…

Jim Gallagher2021 年 10 月 25 日

治疗专长

PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA

利用一种罕见病的临床数据支持另一种罕见病的药物审批

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

什么是 FDA Project Optimus？它会如何影响肿瘤药物开发？

肿瘤药物开发人员应该从 FDA Project Optimus 中期待获得什么？

抗体-药物偶联物的 PBPK 模型 — 概念和应用

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

A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease

开发靶向共价抑制剂药物：3关键考虑因素

Certara Simcyp™ 新冠肺炎疫苗模型获R&D 100 奖

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