Clinical Pharmacology Archives

Blog

Why cancer drug programs need human mass balance studies

Historically, drug programs for oncology and other rapidly fatal diseases didn’t include mass balance studies…

CertaraSeptember 23, 2024

Blog

Resmetirom: A pioneering NASH clinical program

Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…

CertaraAugust 23, 2024

On-Demand Webinar

Using Quantitative Systems Pharmacology (QSP) Modeling for Oncology Dose Optimization

The FDA’s Project Optimus initiative aims to reform dose optimization and selection for oncology therapies…

CertaraAugust 19, 2024

Case Study

Medicines that matter: Biohaven’s Nurtec™ drug development journey

In February 2020, Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved…

CertaraAugust 15, 2024

On-Demand Webinar

Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies

Targeted radiation therapies (TRT) deliver cytotoxic radiation selectively to tumors. In recent years, oncology drug…

CertaraMay 22, 2024

Blog

Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…

CertaraMay 10, 2024

Press Coverage

Modeling and simulation in pediatric drug development

Published: December 21, 2023 This is the article written in German, published on pharmind. Children's…

CertaraDecember 21, 2023

Conference

ACoP 2025

CertaraMay 24, 2023

Case Study

Translational Pharmacology Consulting Supports Combination Therapy for Treating Pulmonary Mycobacterium Avium Complex Disease

RedHill Biopharma Ltd., a specialty biopharmaceutical company, developed RHB-204, a treatment for MAC, and needed…

CertaraMay 9, 2023

On-Demand Webinar

Therapeutic Proteins’ Drug-Drug Interactions: Updates & Challenges

Therapeutic proteins (TP) - and more specifically monoclonal antibodies - are part of the therapeutic…

CertaraDecember 5, 2022

Clinical Pharmacology

Why cancer drug programs need human mass balance studies

Resmetirom: A pioneering NASH clinical program

Using Quantitative Systems Pharmacology (QSP) Modeling for Oncology Dose Optimization

Medicines that matter: Biohaven’s Nurtec™ drug development journey

Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies

Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

Modeling and simulation in pediatric drug development

ACoP 2025

Translational Pharmacology Consulting Supports Combination Therapy for Treating Pulmonary Mycobacterium Avium Complex Disease

Therapeutic Proteins’ Drug-Drug Interactions: Updates & Challenges

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