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dc.contributor.authorNguyen, Ashley
dc.contributor.authorChow, Diana S-L
dc.contributor.authorWu, Lei
dc.contributor.authorTeng, Yang Angela
dc.contributor.authorSarkar, Mahua
dc.contributor.authorToups, Elizabeth G
dc.contributor.authorHarrop, James S
dc.contributor.authorSchmitt, Karl M
dc.contributor.authorJohnson, Michele M
dc.contributor.authorGuest, James D
dc.contributor.authorAarabi, Bizhan
dc.contributor.authorShaffrey, Christopher I
dc.contributor.authorBoakye, Maxwell
dc.contributor.authorFrankowski, Ralph F
dc.contributor.authorFehlings, Michael G
dc.contributor.authorGrossman, Robert G
dc.date.accessioned2021-07-26T19:21:45Z
dc.date.available2021-07-26T19:21:45Z
dc.date.issued2021-04-28
dc.identifier.urihttp://hdl.handle.net/10713/16231
dc.description.abstractRiluzole, a benzothiazole sodium channel blocker that received US Food and Drug Administration approval to attenuate neurodegeneration in amyotrophic lateral sclerosis in 1995, was found to be safe and potentially efficacious in a spinal cord injury (SCI) population, as evident in a phase I clinical trial. The acute and progressive nature of traumatic SCI and the complexity of secondary injury processes can alter the pharmacokinetics of therapeutics. A 1-compartment with first-order elimination population pharmacokinetic model for riluzole incorporating time-dependent clearance and volume of distribution was developed from combined data of the phase 1 and the ongoing phase 2/3 trials. This change in therapeutic exposure may lead to a biased estimate of the exposure-response relationship when evaluating therapeutic effects. With the developed model, a rational, optimal dosing scheme can be designed with time-dependent modification that preserves the required therapeutic exposure of riluzole. © 2021 The Authors..en_US
dc.description.urihttps://doi.org/10.1002/jcph.1876en_US
dc.language.isoenen_US
dc.publisherWiley-Blackwellen_US
dc.relation.ispartofJournal of Clinical Pharmacologyen_US
dc.rights© 2021 The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.en_US
dc.subjectpharmacokineticsen_US
dc.subjectpopulation modelingen_US
dc.subjectriluzoleen_US
dc.subjectspinal cord injuryen_US
dc.titleLongitudinal Impact of Acute Spinal Cord Injury on Clinical Pharmacokinetics of Riluzole, a Potential Neuroprotective Agenten_US
dc.typeArticleen_US
dc.identifier.doi10.1002/jcph.1876
dc.identifier.pmid33908635
dc.source.countryEngland


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