Jim Gallagher, Author at Certara | 第 18 页，共 25 页

Alkermes

Case Study

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…

Jim Gallagher2021 年 8 月 12 日

Genentech

Case Study

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…

Jim Gallagher2021 年 8 月 12 日

网络研讨会点播

生物制剂的临床药理计划是怎样的？

Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and…

Jim Gallagher2021 年 8 月 6 日

Press Release

Certara to Acquire Pinnacle 21, a Leader in Data Standardization Software for Pharmaceutical Clinical Data

Transaction expected to be accretive to Certara’s revenue, revenue growth and adjusted EBITDA margin Princeton,…

Jim Gallagher2021 年 8 月 5 日

Case Study

Takeover of lifecycle maintenance of investigational new drug applications

A Tier 3 Sponsor with active clinical investigations and multiple active, existing Investigational New Drug Applications (INDs) was unhappy with their current vendor’s support. The Sponsor selected Certara as its new vendor for…

Jim Gallagher2021 年 8 月 2 日

Publication

应用定量系统药理学（QSP）指导 COVID-19 疫苗最佳剂量方案

Optimal use and distribution of coronavirus disease 2019 (COVID-19) vaccines involves adjustments of dosing. Due…

Jim Gallagher2021 年 7 月 31 日

Case Study

Simcyp™ Simulator 证明了生物等效性 (BE)，无需进行昂贵的临床研究

In this case study, the sponsor’s closing of a manufacturing site required that one of…

Jim Gallagher2021 年 7 月 29 日

Pharmacyclics and Janssen

Case Study

使用 Simcyp 模拟器的 DDI 监管海报：Ibrutinib (Imbruvica®)

Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…

Jim Gallagher2021 年 7 月 29 日

On-Demand Webinar

PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking

This webinar was presented on 2021 年 6 月 30 日 by David R. Taft, Ph.D. Professor, Pharmaceutics,…

Jim Gallagher2021 年 7 月 26 日

视频

What is BaseCase?

Developing interactive and easy-to-use stakeholder engagement content market access, medical affairs, and sales field teams…

Jim Gallagher2021 年 7 月 20 日

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