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Clinical Pharmacology & Therapeutics
Article . 2018 . Peer-reviewed
License: CC BY NC
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Clinical Pharmacology & Therapeutics
Article
License: CC BY NC
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PubMed Central
Other literature type . 2018
Data sources: PubMed Central
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Radboud Repository
Article . 2018
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Interchangeability of Generic Drugs: A Nonparametric Pharmacokinetic Model of Gabapentin Generic Drugs

A Nonparametric Pharmacokinetic Model of Gabapentin Generic Drugs
Authors: Glerum, Pieter J.; Yu, Y.; Yamada, Walter M.; Neely, M.N.; Maliepaard, M.; Burger, D.M.; Neef, C.;

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

Abstract

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.

Country
Netherlands
Keywords

Adult, Male, Drug Substitution, Research, Administration, Oral, Reproducibility of Results, Middle Aged, Radboudumc 11: Renal disorders RIMLS: Radboud Institute for Molecular Life Sciences, Models, Biological, Statistics, Nonparametric, Renal Elimination, Young Adult, All institutes and research themes of the Radboud University Medical Center, Therapeutic Equivalency, Gastrointestinal Absorption, Drugs, Generic, Humans, Computer Simulation, Female, Gabapentin, Radboudumc 4: lnfectious Diseases and Global Health RIHS: Radboud Institute for Health Sciences, METAANALYSIS

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    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    7
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Top 10%
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
7
Top 10%
Average
Average
Green
hybrid