Clinical pharmacology to support monoclonal antibody drug development

Abstract

Clinical pharmacology is a multidisciplinary function playing a critical role in the monoclonal antibody development. Besides the requirements of understanding pharmacology, pharmacokinetics, model simulation, biostatistics and immunogenicity, wisely implementation of tactics and strategies to fulfill the agencies' requirements per guidance documents are critical. In this review, clinical pharmacology studies categorized as required, target dependent, development strategy dependent, and not usually needed are discussed. The review ends with the outlook of recent initiations in the clinical pharmacology such as the application of QSP with the integration of AI and machine learning technologies.