Skip to Main Content
Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases
book

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases

by Honghui Zhou, Diane R. Mould
March 2019
Intermediate to advanced content levelIntermediate to advanced
496 pages
15h
English
Wiley
Content preview from Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases

6Utility of Joint Population Exposure–Response Modeling Approach to Assess Multiple Continuous and Categorical Endpoints in Immunology Drug Development

Chuanpu Hu and Honghui Zhou

Janssen Research and Development, LLC, Global Clinical Pharmacology, 1400 McKean Road, Spring House, PA, 19477, USA

6.1 Introduction

Exposure–response (E–R) modeling of clinical endpoints is important for drug development by facilitating informative dose regimen selection. A widely used class of E–R models includes the Types I–IV indirect response (IDR) models [1]. These models are most often used to describe continuous physiological endpoints and their presumed consistency with the mechanism of drug action lends confidence to the model predictions. However, clinical trial endpoints are often disease scores that are not physiological variables. For example, two types of commonly used efficacy endpoints in rheumatoid arthritis (RA) are the 28‐joint disease activity score using CRP (DAS28) and 20%, 50%, and 70% improvement in the American College of Rheumatology disease severity criteria (ACR20, ACR50, and ACR70) [2]. In psoriatic arthritis (PsA), the Psoriasis Area and Severity Index (PASI) score, ranged 0–72 with 0.1 increments, is used in addition to the ACR criteria (for arthritis component) to measure the severity of the psoriatic component of the disease. Applications of IDR models to categorical clinical endpoints have emerged in the last decade via the latent variable approach [3].

Clinical trials ...

Become an O’Reilly member and get unlimited access to this title plus top books and audiobooks from O’Reilly and nearly 200 top publishers, thousands of courses curated by job role, 150+ live events each month,
and much more.
Start your free trial

You might also like

Applied Computing in Medicine and Health

Applied Computing in Medicine and Health

Dhiya Al-Jumeily, Abir Hussain, Conor Mallucci, Carol Oliver
Informatics for Health Professionals

Informatics for Health Professionals

Kathleen Mastrian, Dee McGonigle
Nanostructures for Novel Therapy

Nanostructures for Novel Therapy

Denisa Ficai, Alexandru Mihai Grumezescu

Publisher Resources

ISBN: 9781119289197Purchase book