Therapeutic Specialties Archives

Case Study

Small Biotech Clinical Trial Application (CTA) & Investigational New Drug (IND) Submission Success with Integrated Project Management

Find out how Certara helped a small biotech achieve on-time IND and CTA submissions with…

Certara2025 年 8 月 18 日

Publication

Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial

Explore updated results from the Phase 3 TROPiCS-02 trial of Sacituzumab Govitecan in advanced HR+/HER2–…

Certara2025 年 8 月 13 日

Blog

基于模型的荟萃分析（MBMA）在 GSK 的应用：对战略和临床试验的实际影响

GSK shares real-world case studies on how Model-Based Meta-Analysis (MBMA) supports dose selection, virtual control…

Certara2025 年 7 月 31 日

Press Coverage

数字孪生与虚拟试验：重塑罕见病药物研发新范式

Discover how using digital twins in rare disease drug development is improving precision and accelerating…

Certara2025 年 7 月 22 日

Publication

建模与模拟及真实世界证据在临床试验多样性规划中的关键作用：挑战应对策略

Due to the highly controlled settings of clinical trials, enrolled subjects may not be fully…

Danielle Pillsbury2025 年 6 月 19 日

On-Demand Webinar

从数据到决策：基于模型的荟萃分析（MBMA）与 GSK 和 Certara 真实世界影响

Discover the Real-World Impact of Model-Based Meta-Analysis. Hear from experts, see case studies to advance…

Certara2025 年 6 月 18 日

Publication

Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer

The study, published in the Journal of Clinical Pharmacology, evaluates the cardiac safety of fruquintinib,…

Certara2025 年 6 月 8 日

Publication

HIV 病毒学抑制青少年中长效注射用 cabotegravir 与长效注射用 rilpivirine 联合用药的安全性研究（IMPAACT 2017/MOCHA）：一项 1/2 期、多中心、开放标签、非比较性的剂量探索研究

The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…

Certara2025 年 3 月 20 日

Video

Gene Therapy: A Transformative Shift in Rare Disease Treatment

After decades of promise, gene therapy is finally starting to deliver on its potential—especially for…

Certara2025 年 2 月 26 日

Publication

针对复发难治性（R/R）骨髓纤维化（MF）及其他髓系或实体瘤恶性肿瘤患者的 Navtemadlin 群体药代动力学与药效学分析

This study conducted a population pharmacokinetic (PK) and pharmacodynamic (PD) analysis of navtemadlin, an MDM2…

Certara2025 年 2 月 6 日

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Small Biotech Clinical Trial Application (CTA) & Investigational New Drug (IND) Submission Success with Integrated Project Management

Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial

基于模型的荟萃分析（MBMA）在 GSK 的应用：对战略和临床试验的实际影响

数字孪生与虚拟试验：重塑罕见病药物研发新范式

建模与模拟及真实世界证据在临床试验多样性规划中的关键作用：挑战应对策略

从数据到决策：基于模型的荟萃分析（MBMA）与 GSK 和 Certara 真实世界影响

Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer

HIV 病毒学抑制青少年中长效注射用 cabotegravir 与长效注射用 rilpivirine 联合用药的安全性研究（IMPAACT 2017/MOCHA）：一项 1/2 期、多中心、开放标签、非比较性的剂量探索研究

Gene Therapy: A Transformative Shift in Rare Disease Treatment

针对复发难治性（R/R）骨髓纤维化（MF）及其他髓系或实体瘤恶性肿瘤患者的 Navtemadlin 群体药代动力学与药效学分析

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