Jim Gallagher

On-Demand Webinar

更智能的临床文件自动化，满足透明度和信息披露要求

Transparency and disclosure efforts are an integral part of medical writing for submissions. Sponsors receive…

Jim Gallagher2022 年 4 月 14 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

Blog

Phoenix WinNonlin 助力 PK/PD 分析的 5 大核心优势

Pharmaceutical companies around the globe face the challenge of increasingly longer drug development cycles and…

Jim Gallagher2022 年 3 月 25 日

Fact Sheet

SEND Explorer - 产品系列

探索 SEND Explorer 如何变革非临床数据分析。

Jim Gallagher2022 年 3 月 23 日

On-Demand Webinar

eChalk Talk: 肿瘤药物开发商如何为 FDA Project Optimus 做好准备

Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated…

Jim Gallagher2022 年 3 月 22 日

Video

The Value of BaseCase

Jim Gallagher2022 年 3 月 21 日

Announcement

Certara Selected by the European Medicines Agency to Provide Real World Solutions for Critical Regulatory Decisions

Princeton, N.J., 2022 年 3 月 17 日 -- Certara, Inc. today announced a four-year, framework service contract…

Jim Gallagher2022 年 3 月 17 日

Blog

如何纠正生物等效性评估中的重大误区

生物等效性是生物药剂学中普遍被误解的术语。For starters, bioequivalence is a technical term…

Jim Gallagher2022 年 3 月 16 日

Conference

ASCPT 2024 Annual Meeting

Jim Gallagher2022 年 3 月 7 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