Statistical Considerations in Assessing Drug–Drug Interactions for Therapeutic Biologics
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
Hu, C. and Zhou, H. 2013. Statistical Considerations in Assessing Drug–Drug Interactions for Therapeutic Biologics. Pharmaceutical Sciences Encyclopedia. 9:1–16.
- Published Online: 19 JUN 2013
Therapeutic biologics have different mechanisms of action from small molecules, usually making drug–drug interactions (DDIs) less likely, although this may depend on the specific circumstances. That is, the a priori expectation of specific DDIs is different with therapeutic biologics. In addition, therapeutic biologics usually have long half-lives, preventing the effective use of the usual crossover trials to assess drug–drug interactions. These issues influence the design and analysis of DDI assessments. Furthermore, population pharmacokinetics modeling has been used increasingly in drug development and has promising potential in DDI assessment. This chapter discusses the associated statistical issues, particularly to ensure appropriate power and type I error.
- drug–drug interactions;
- population pharmacokinetics modeling;