A nonlinear mixed effects IVIVC model for multi-release drug delivery systems.
The purpose of this analysis was the development of an IVIVC model, which involves a convolution step as described by O'Hara et al. and to describe a dual-release system: a controlled release formulation, which contains an initial immediate release element. Four formulations of Galantamine were used to test this modelling technique and a level A IVIVC, which meets the FDA criteria for internal and external validation, was successfully developed.
Rossenu
S
S
Johnson and Johnson Pharmaceutical Research & Development, A Division of Janssen Pharmaceutica NV, Beerse, Belgium. srossenu@its.jnj.com
Gaynor
C
C
Vermeulen
A
A
Cleton
A
A
Dunne
A
A
D000293:Adolescent; D000328:Adult; D000465:Algorithms; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D005260:Female; D005702:Galantamine / Q000493:pharmacokinetics / Q000494:pharmacology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017711:Nonlinear Dynamics; D018697:Nootropic Agents / Q000493:pharmacokinetics / Q000494:pharmacology; D011153:Population; D016032:Randomized Controlled Trials as Topic; D012995:Solubility; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
D003692:Delayed-Action Preparations; D018697:Nootropic Agents; D005702:Galantamine
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