Modeling and Simulation - PK/PD Archives

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Mean Residence Time (MRT): Understanding How Long Drug Molecules Stay in the Body

JTVCdGVhbV9qdW1wX2xpc3QlNUQ= 2026 年 4 月 16 日 When I first began learning about pharmacokinetics (PK), I was often…

Certara2026 年 4 月 16 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

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

Blog Knowledge Base

Where Did the 80-125% Bioequivalence Criteria Come From?

Discover what bioequivalence criteria mean, why the 80-125% bioequivalence range is used, and how custom…

Certara2026 年 3 月 27 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

On-Demand Webinar

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Watch this on-demand webinar to learn how model-informed strategies using PopPK, PBPK, and QSP can…

Certara2026 年 3 月 25 日

Publication

Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis

This study evaluated the pharmacokinetics (PK) and pharmacokinetic–pharmacodynamic (PK–PD) relationship of clazakizumab, an anti–interleukin-6 (IL-6)…

Danielle Pillsbury2026 年 3 月 24 日

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Modeling and Simulation – PK/PD

Mean Residence Time (MRT): Understanding How Long Drug Molecules Stay in the Body

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)

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

Where Did the 80-125% Bioequivalence Criteria Come From?

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

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis

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