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Logistic Considerations in Study Design for Biologic Drug–Drug Interaction Assessments

Drug-Drug Interactions for Therapeutic Biologics

  1. Min Zhu,
  2. Yu-Nien (Tom) Sun

Published Online: 19 JUN 2013

DOI: 10.1002/9780470571224.pse479

Pharmaceutical Sciences Encyclopedia

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.

Author Information

  1. Quantitative Pharmacology, Department of Pharmacokinetics and Drug Metabolism, Thousand Oaks, CA, USA

Publication History

  1. Published Online: 19 JUN 2013

Abstract

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.

Keywords:

  • therapeutic proteins;
  • drug-drug interactions;
  • screening studies;
  • estimation studies;
  • dedicated studies;
  • study design