Publication

Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

Population pharmacokinetic (PopPK) and exposure-response modeling were used to support the clinical development of nemtabrutinib,…

Certara2026 年 5 月 7 日

On-Demand Webinar

Pharmacometrics Under Pressure: The Quantitative Clinical Pharmacology Sprint

Explore how Phoenix NLME and RsNLME support early phase clinical pharmacology workflows where speed, clarity,…

Certara2026 年 5 月 6 日

Blog

GxP compliance in the cloud: What IT teams need to rethink

Learn how GxP validation works in modern SaaS and cloud environments, with best practices for…

Certara2026 年 5 月 4 日

Webinar

ICH M13B Strength Biowaiver

Certara2026 年 4 月 28 日

Blog

ADC dose optimization: Applying model-informed strategies in development

Explore ADC dose optimization using model-informed strategies to balance efficacy and safety across antibody drug…

Certara2026 年 4 月 22 日

On-Demand Webinar

Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access

Learn how model-informed strategies support ADC labeling, dose optimization, and market access through integrated evidence…

Certara2026 年 4 月 10 日

Webinar

When pharmacokinetics meets pharmacogenomics: Genetic Insights into Fluoxetine PK for Personalized Antidepressant Therapy

Certara2026 年 4 月 10 日

Blog

PK parameters explained: From Cmax to clearance (and why it matters for development decisions)

Learn how key PK parameters such as Cmax, AUC, clearance, half life, and volume of…

Sebastian Kuechenmeister2026 年 4 月 9 日

Case Study

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

HUTCHMED was preparing a New Drug Application (NDA) submission for FRUZAQLA® (fruquintinib) a drug developed…

Certara2026 年 4 月 7 日

On-Demand Webinar

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

Watch this on-demand webinar to learn how the final ICH M15 guidance is shaping Model-Informed…

Certara2026 年 4 月 2 日

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Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

Pharmacometrics Under Pressure: The Quantitative Clinical Pharmacology Sprint

GxP compliance in the cloud: What IT teams need to rethink

ICH M13B Strength Biowaiver

ADC dose optimization: Applying model-informed strategies in development

Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access

When pharmacokinetics meets pharmacogenomics: Genetic Insights into Fluoxetine PK for Personalized Antidepressant Therapy

PK parameters explained: From Cmax to clearance (and why it matters for development decisions)

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

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