Modeling and Simulation - PK/PD Archives | Page 2 of 47

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…

CertaraApril 9, 2026

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…

CertaraApril 2, 2026

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 PillsburyApril 2, 2026

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…

CertaraMarch 27, 2026

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…

CertaraMarch 26, 2026

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…

CertaraMarch 26, 2026

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…

CertaraMarch 25, 2026

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 PillsburyMarch 24, 2026

Publication

Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis

This article describes how a model-informed drug development (MIDD) approach was used to support the…

CertaraMarch 24, 2026

Blog

Regulatory horizons 2026: clinical pharmacology strategy and regulatory expectations

Learn how regulatory expectations in clinical pharmacology are evolving and how to build a strategy…

CertaraMarch 24, 2026

Modeling and Simulation – PK/PD

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

Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis

Regulatory horizons 2026: clinical pharmacology strategy and regulatory expectations

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