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From Biological Mechanisms to Causal Inference: Quantitative Systems Pharmacology and Causal Frameworks in Drug Development

From Biological Mechanisms to Causal Inference: Quantitative Systems Pharmacology and Causal Frameworks in Drug Development

Securing Pimicotinib Approval: How Abbisko Therapeutics Successfully Completed its NMPA and FDA Submissions with Pinnacle 21 Enterprise

Securing Pimicotinib Approval: How Abbisko Therapeutics Successfully Completed its NMPA and FDA Submissions with Pinnacle 21 Enterprise

Get the Presentation: Building Investor-Ready Biotech Strategies

Get the Presentation: Building Investor-Ready Biotech Strategies

From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs

From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs

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From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs

From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs

Upcoming preclinical webinars

网络研讨会

From PK Data to Document: An AI-Driven Daytrip with Phoenix Cloud

Oct 1, Oct 2

网络研讨会

The Road to First-in-Human: Model-Informed Decisions from Discovery to First Dose

Oct 6, Oct 27, Nov 10

网络研讨会

Enable AI to Access your PK Data: What’s New in Integral 7.1

2026 年 10 月 13 日 – 10:00 - 11:00am ET

Latest preclinical blogs

All Preclinical - Blog

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

细胞疗法开发的主要考虑因素

支持生物等效性和仿制药审批的 PBPK 建模

The future is now: Virtual clinical trials transforming drug development

Phoenix UGM 2024: A day of innovation and collaboration

在以下活动中与我们的专家会面

BioTechX Europe 2026

2026 年 10 月 6 - 8 日

ISSX 27th North American Meeting

October 11 - 14, 2026 – San Francisco, CA

ACoP 2026

2026 年 10 月 11 - 14 日

All preclinical resources

From Biological Mechanisms to Causal Inference: Quantitative Systems Pharmacology and Causal Frameworks in Drug Development

Modeling and Simulation - QSP, Publication

Securing Pimicotinib Approval: How Abbisko Therapeutics Successfully Completed its NMPA and FDA Submissions with Pinnacle 21 Enterprise

Certara Products - Pinnacle 21, Case Study

Get the Presentation: Building Investor-Ready Biotech Strategies

Drug Development, Drug Development Support, Guide

Enable AI to Access your PK Data: What’s New in Integral 7.1

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

From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs

Certara Products - Certara IQ, Certara Products - Simcyp, Infectious Disease, Modeling and Simulation, Modeling and Simulation - PBPK, Modeling and Simulation - QSP, Oncology/Hematology, Publication

Modeling effective doses of therapeutic antibodies targeting clustered surface receptors

Biologics, Certara Services, Immuno-oncology, Modeling and Simulation - PK/PD, Modeling and Simulation - QSP, Oncology/Hematology, Publication

Model-Informed Strategies for ADC Development

ADC, Biologics, Certara Services, Clinical Pharmacology, Drug Development, Model Informed Drug Development, Modeling and Simulation, Modeling and Simulation - PBPK, Modeling and Simulation - PK/PD, Modeling and Simulation - QSP, Therapeutic Specialties, White Paper

When EV Dose Is Not What It Seems: Quantitative Mismatch Between Particle Number- and Protein-Based Dosing

Certara Services, Drug Development, Model Informed Drug Development, Oncology, Pharmacometrics, Publication

External Data Accelerator: Your standards-first team and technology for conformant vendor data

Certara Products - Pinnacle 21, Certara Services, Data Standards, Fact Sheet

Pharmacometrics Approach Group in Japan 2026

Modeling and Simulation - PBPK, Modeling and Simulation - QSP, Conference

Beyond Simple Allometric Scaling: Why Time-Course Methods Win for First-in-Human Predictions

Modeling and Simulation - PK/PD, Blog

Beyond NAMs versus animal models: Context of use as the governing framework for integrated nonclinical strategies in drug development

Certara Services, Drug Development, Drug Safety, Model Informed Drug Development, Modeling and Simulation, Modeling and Simulation - QSP, New Approach Methodologies (NAMs), Publication

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