Clinical Pharmacology Archives

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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…

Certara2026 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

Webinar

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

Danielle Pillsbury2026 年 4 月 2 日

Publication

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib

This study demonstrates how a model-informed, totality-of-evidence approach was used to select the optimal clinical…

Danielle Pillsbury2026 年 4 月 2 日

Case Study

Integrated PK/PD Modeling and Machine Learning to Support CNS Compound Selection

PK/PD Modeling for CNS drug development using Phoenix NLME and machine learning for better CNS…

Certara2026 年 3 月 26 日

Publication

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

This review article examines the development of radiopharmaceutical imaging agents and radioligand therapies for pediatric…

Certara2026 年 3 月 26 日

Publication

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

This publication highlights how pharmacometric modeling, supported by Certara, was used to inform dose selection…

Certara2026 年 3 月 25 日

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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

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib

Integrated PK/PD Modeling and Machine Learning to Support CNS Compound Selection

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

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