Interchangeability of Generic Drugs: A Nonparametric Pharmacokinetic Model of Gabapentin Generic Drugs

Pieter J. Glerum*, Yang Yu, Walter M. Yamada, Michael N. Neely, Marc Maliepaard, David M. Burger, Cees Neef

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Substitution by generic drugs is allowed when bioequivalence to the originator drug has been established. However, it is known that similarity in exposure may not be achieved at every occasion for all individual patients when switching between formulations. The ultimate aim of our research is to investigate if pharmacokinetic subpopulations exist when subjects are exposed to bioequivalent formulations. For that purpose, we developed a pharmacokinetic model for gabapentin, based on data from a previously conducted bioavailability study comparing gabapentin exposure following administration of the gabapentin originator and three generic gabapentin formulations in healthy subjects. Both internal and external validation confirmed that the optimal model for description of the gabapentin pharmacokinetics in this comparative bioavailability study was a two-compartment model with absorption constant, an absorption lag time, and clearance adjusted for renal function, in which each model parameter was separately estimated per administered formulation.

Original languageEnglish
Pages (from-to)966-973
Number of pages8
JournalClinical Pharmacology & Therapeutics
Issue number5
Publication statusPublished - Nov 2018




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