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Statistical Considerations in Assessing Drug–Drug Interactions for Therapeutic Biologics

Drug-Drug Interactions for Therapeutic Biologics

  1. Chuanpu Hu,
  2. Honghui Zhou

Published Online: 19 JUN 2013

DOI: 10.1002/9780470571224.pse480

Pharmaceutical Sciences Encyclopedia

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.

Author Information

  1. Janssen Research & Development, LLC, Pharmacokinetics and Pharmacometrics, Biologics Clinical Pharmacology, Spring House, PA, USA

Publication History

  1. Published Online: 19 JUN 2013

Abstract

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.

Keywords:

  • drug–drug interactions;
  • safety;
  • efficacy;
  • population pharmacokinetics modeling;
  • AUC;
  • bootstrap