Evaluation of in vivo P-glycoprotein phenotyping probes: a need for validation

Clin Pharmacokinet. 2010 Apr;49(4):223-37. doi: 10.2165/11318000-000000000-00000.

Abstract

Drug transporters are involved in clinically relevant drug-drug interactions. P-glycoprotein (P-gp) is an efflux transporter that displays genetic polymorphism. Phenotyping permits evaluation of real-time, in vivo P-gp activity and P-gp-mediated drug-drug interactions. Digoxin, fexofenadine, talinolol and quinidine are commonly used probe drugs for P-gp phenotyping. Although current regulatory guidance documents highlight methodologies for evaluating transporter-based drug-drug interactions, whether current probe drugs are suitable for phenotyping has not been established, and validation criteria are lacking. This review proposes validation criteria and evaluates P-gp probes to determine probe suitability. Based on these criteria, digoxin, fexofenadine, talinolol and quinidine have limitations to their use and are not recommended for P-gp phenotyping.

Publication types

  • Review

MeSH terms

  • ATP Binding Cassette Transporter, Subfamily B, Member 1 / genetics*
  • ATP Binding Cassette Transporter, Subfamily B, Member 1 / metabolism*
  • Digoxin / pharmacokinetics
  • Drug Interactions / genetics*
  • Genotype
  • Humans
  • Pharmacogenetics
  • Phenotype
  • Polymorphism, Single Nucleotide
  • Prescription Drugs / pharmacokinetics*
  • Propanolamines / pharmacokinetics
  • Quinidine / pharmacokinetics
  • Reproducibility of Results
  • Terfenadine / analogs & derivatives
  • Terfenadine / pharmacokinetics

Substances

  • ATP Binding Cassette Transporter, Subfamily B, Member 1
  • Prescription Drugs
  • Propanolamines
  • talinolol
  • Digoxin
  • Terfenadine
  • fexofenadine
  • Quinidine