Logistic Considerations in Study Design for Biologic Drug–Drug Interaction Assessments
Drug-Drug Interactions for Therapeutic Biologics
Published Online: 19 JUN 2013
Copyright © 2010 John Wiley & Sons, Inc. All rights reserved.
Pharmaceutical Sciences Encyclopedia
How to Cite
Zhu, M. and Sun, Y.-N. 2013. Logistic Considerations in Study Design for Biologic Drug–Drug Interaction Assessments. Pharmaceutical Sciences Encyclopedia. 8:1–20.
- Published Online: 19 JUN 2013
Due to the unique characteristics of biologics in pharmacokinetics and immunogenicity, some design parameters of therapeutic protein (TP)–drug interaction studies are different from those for small molecules. A risk-based drug–drug interaction assessment strategy for TPs should be implemented according to its risk factors, and appropriate study designs should be selected. The challenges and logistic considerations in study designs for TP–drug interactions are discussed in this chapter.
- therapeutic proteins;
- drug-drug interactions;
- screening studies;
- estimation studies;
- dedicated studies;
- study design