Drug Safety Archives

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

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

Blog Knowledge Base

What is GLP (Good Laboratory Practice)?

Read this blog to understand GLP (Good Laboratory Practice) and associated QA audits, and proper…

CertaraMarch 18, 2026

Blog

Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026

Explore how model-informed drug development and AI are advancing pharmacoequity and shaping the future of…

CertaraMarch 11, 2026

Blog

ADC First-in-Human (FIH) Dose Selection: Designing FIH Studies for Success

Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more…

CertaraMarch 3, 2026

On-Demand Webinar

Start right, finish strong: Antibody-drug conjugate (ADC) studies for success

Learn how to build regulatory-ready first-in-human (FIH) dose strategies for antibody-drug conjugates (ADCs). Discover how…

CertaraFebruary 23, 2026

Blog

FAQs: The ICH M15 Guideline and What It Means for Model-Informed Drug Development

Learn what the ICH M15 guideline means for Model-Informed Drug Development, regulatory credibility, harmonization, and…

CertaraFebruary 18, 2026

Blog

How Model-Informed Drug Development (MIDD) Strengthens Drug Asset Valuation and Answers the Questions Investors Care About Most

Learn how Model-Informed Drug Development strengthens drug asset valuation by reducing uncertainty, predicting clinical performance,…

CertaraJanuary 26, 2026

Drug Safety

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

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

What is GLP (Good Laboratory Practice)?

Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026

ADC First-in-Human (FIH) Dose Selection: Designing FIH Studies for Success

Start right, finish strong: Antibody-drug conjugate (ADC) studies for success

FAQs: The ICH M15 Guideline and What It Means for Model-Informed Drug Development

How Model-Informed Drug Development (MIDD) Strengthens Drug Asset Valuation and Answers the Questions Investors Care About Most

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