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早期临床

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Pinnacle 21 Enterprise Plus: Your Route to Faster, Compliant SDTM Mapping Specs

Pinnacle 21 Enterprise Plus: Your Route to Faster, Compliant SDTM Mapping Specs

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

Best Practices for AI Prompt Engineering in Life Sciences in 2025

Best Practices for AI Prompt Engineering in Life Sciences in 2025

精选资源

Bottlenecks to Breakthroughs: Tackling Challenges in QSP Modeling

Bottlenecks to Breakthroughs: Tackling Challenges in QSP Modeling

Upcoming early clinical webinars

网络研讨会

Phoenix Hosted: 基于云的 PK/PD 软件可实现更智能、更快速的研究

2025 年 10 月 28 日 – 11am（美东时间）

网络研讨会

The Impact of Standardized eCRFs from Data Collection to Submission

2025 年 10 月 30 日 – 9:30am ET

网络研讨会

Certara IQ™: The Scalable AI-Powered QSP Software

2025 年 10 月 30 日 – 10 am ET

Latest early clinical blogs

All Early clinical - Blog

药物开发中 PK/PD 建模的机器学习

美国 FDA MIDD 配对试点计划如何帮助赞助商

揭秘临床 DDI 研究：精准测量代谢产物

为何 FDA 批准 omaveloxolone 用于治疗弗里德赖希共济失调症意义重大

细胞疗法开发的主要考虑因素

降低药物开发风险：早期开发中的关键化学、制造和控制（CMC）及基于生理的药代动力学（PBPK）方法

在以下活动中与我们的专家会面

AAPS 2025 PharmSci 360

November 9 - 12, 2025

PHUSE EU Connect

November 16 - 19, 2025 – Hamburg, Germany

Phoenix Roadshow 2025 – Basel

2025 年 11 月 19 日

All early clinical resources

SDTM 规范管理

Certara Products - Pinnacle 21, Fact Sheet

Arena Clinical Data Management

Certara Products - Pinnacle 21, Conference

Quantitative Systems Pharmacology-Based Virtual Twin® Approach for Clinical Development in Rare Diseases

Model Informed Drug Development, Modeling and Simulation, Modeling and Simulation - QSP, On-Demand Webinar

Pirana 技巧与窍门 — Pirana 中的报告对象生成

Certara 产品，网络研讨会

参比标度平均生物等效性（Reference-scaled Average Bioequivalence, RSABE）方法

Certara Products, Certara Products - Phoenix, Modeling and Simulation - PK/PD, Blog

SCDM 2025 Annual Conference

Certara Products - Pinnacle 21, Conference

5 大临床开发挑战 — 基于模型的荟萃分析（MBMA）助力应对

Certara Products, Certara Services, Clinical Trials, Drug Development, Model Informed Drug Development, Model-Based Meta-Analysis (MBMA), Modeling and Simulation, Modeling and Simulation - PK/PD, Blog

如何通过模型引导的药物开发助力项目从高风险局面中脱困

Certara Services, Clinical Pharmacology, Model Informed Drug Development, Modeling and Simulation, Modeling and Simulation - PBPK, Modeling and Simulation - PK/PD, Modeling and Simulation - QSP, Case Study

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

Certara Services, Clinical Trials, Drug Development, Drug Safety, Model Informed Drug Development, Modeling and Simulation, Therapeutic Specialties, Publication

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

Certara Services, Clinical Pharmacology, Drug Development, Drug Safety, Infectious Disease, Model Informed Drug Development, Model-Based Meta-Analysis (MBMA), Modeling and Simulation, Modeling and Simulation - PK/PD, Therapeutic Specialties, On-Demand Webinar

制药行业是如何应对全球健康不平等问题的？

Certara Products - Simcyp, Certara Services, Modeling and Simulation - PBPK, Press Coverage

加速源数据到 SDTM 标准的映射进程

Certara Products - Pinnacle 21, SDTM, On-Demand Webinar

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