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…

Rajesh Krishna2026 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

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…

Certara2026 年 3 月 24 日

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…

Certara2026 年 3 月 24 日

Guide

From Numbers to Narrative: Mastering the Art of PK Presentation

Master PK data reporting with a structured guide to presenting pharmacokinetic results clearly and turning…

Certara2026 年 3 月 20 日

On-Demand Webinar

Pharmacometrics Under Pressure

popPK modelers and pharmacometricians, ensure your toolset can handle use cases from translation to population.

Certara2026 年 3 月 20 日

博客

What are common bioequivalence study mistakes?

Learn about the most common bioequivalence study mistakes drug developers make and the differences between…

Certara2026 年 3 月 20 日

Modeling and Simulation – PK/PD

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

From Numbers to Narrative: Mastering the Art of PK Presentation

Pharmacometrics Under Pressure

What are common bioequivalence study mistakes?

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