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Strategic Project Management for Accelerated Drug Development

Strategic Project Management for Accelerated Drug Development

事实资料表

A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection

A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection

A Tutorial on the Development of a Physiologically Inspired PKRO Model for Monoclonal Antibodies

A Tutorial on the Development of a Physiologically Inspired PKRO Model for Monoclonal Antibodies

精选资源

First-in-human dosing model for MDX2004, a novel trispecific CD3xCD28/4-1BB antibody-fusion protein for advanced malignancies

First-in-human dosing model for MDX2004, a novel trispecific CD3xCD28/4-1BB antibody-fusion protein for advanced malignancies

Upcoming early clinical webinars

网络研讨会

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

2026 年 1 月 13 日 – 12:30 pm to 1:30 pm EST

网络研讨会

AI-Powered PK Reporting: From Days to Minutes

2026 年 1 月 15 日 – 10am to 10:45am ET

网络研讨会

Alternative parameters in NCA using Phoenix WinNonlin

2026 年 1 月 21 日 – 10:00 -10:45a,m 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

JPM 2026 44th Annual Healthcare Conference & Biotech Showcase

January 12 - 16, 2026 – San Francisco, CA

ICoP 2026 India

January 28 - 31, 2026

MVA Oncology Network

2026 年 2 月 4 日

All early clinical resources

Strategic Project Management for Accelerated Drug Development

Certara Services, Clinical Trials, Drug Development, Model Informed Drug Development, Fact Sheet

Alternative parameters in NCA using Phoenix WinNonlin

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

MVA Oncology Network

Clinical Pharmacology, Model Informed Drug Development, Modeling and Simulation - PBPK, Modeling and Simulation - PK/PD, Conference

A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection

Certara Services, Clinical Pharmacology, Clinical Trials, Drug Development, Drug Safety, Model Informed Drug Development, Model-Based Meta-Analysis (MBMA), Modeling and Simulation, Publication

A Tutorial on the Development of a Physiologically Inspired PKRO Model for Monoclonal Antibodies

Modeling and Simulation - QSP, Publication

From Unstructured Data to Dose Insights: Applying Modern AI to Exposure Bracketing

Certara Products, Certara.AI, Webinar

ICoP 2026 India

Certara Products - Simcyp, Certara Services, Clinical Pharmacology, Drug Development, Model Informed Drug Development, Modeling and Simulation, Modeling and Simulation - PBPK, Modeling and Simulation - QSP, Conference

7 key annotated CRF regulatory submission requirements you should know

CDISC, Certara Products - Pinnacle 21, Data Standards, Blog

On Virtual Twin® models in rare disease research, with Piet van der Graaf

Modeling and Simulation - QSP, Podcast, Press Coverage

Virtual Triplets: The Next Step in Personalized and Ethical Drug Development

Modeling and Simulation, Modeling and Simulation - PBPK, Modeling and Simulation - QSP, Blog

AI-Powered PK Reporting: From Days to Minutes

Certara Products, Certara Products - Phoenix, Clinical Pharmacology, Webinar

History and Evolution of Innovations in Clinical Pharmacology

Clinical Pharmacology, Model Informed Drug Development, Modeling and Simulation, Publication

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