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factor IIV

Etienne Chatelut, René Bruno, Mark J Ratain
The magnitude of interindividual pharmacokinetic variability (IIV) of a drug and the factors responsible for this variability are intensively studied before-and sometimes after-registration as crucial information in anticipating and understanding variability in toxicity and efficacy. However, there has been much less attention paid to intraindividual variability, reflecting random or systematic changes in an individual's pharmacokinetics over time. We have chosen to focus on small-molecule kinase inhibitors (SMKIs)...
December 1, 2017: Clinical Pharmacology and Therapeutics
Yu Kyong Kim, Anhye Kim, Shin Jung Park, Howard Lee
To evaluate the pharmacokinetic (PK) and tolerability profiles of a new tablet formulation of tacrolimus and its interindividual variability (IIV) in the systemic exposure, and to compare them with those of the conventional capsule formulation, a randomized, open-label, two-treatment, two-period, two-sequence, crossover study was performed in 47 healthy males. The capsule or tablet formulation of tacrolimus was orally administered, and serial blood samples were collected up to 96 hours after dosing. Whole-blood tacrolimus concentration was determined using liquid chromatography-tandem mass spectrometry...
2017: Drug Design, Development and Therapy
S A Khairy, R J Neves, O Hartung, G J O'Sullivan
BACKGROUND: The majority of iliac venous obstructions occur on the left side, and endovascular therapy has become the first line treatment for this condition. A left common iliac venous stent will protrude into the inferior vena cava (IVC) to some extent, thereby covering the contralateral common iliac vein (CIV) outflow. This may increase the risk of thrombosis of the contralateral iliac vein. The aim of this paper was to determine the rate of, and factors associated with, contralateral lower limb venous thrombosis after stenting, and to evaluate the results of salvage revascularisation...
September 5, 2017: European Journal of Vascular and Endovascular Surgery
Benjamin Fogel, Steven Hicks
BACKGROUND: In 2016 the Centers for Disease Control and Prevention (CDC) recommended against using the live attenuated influenza vaccine (LAIV) for the 2016-2017 influenza season. This recommendation is potentially important for vaccination rates because perceived effectiveness and ease of administration are among the primary determinants of families decisions to vaccinate their children. This investigation sought to determine whether rates of pediatric influenza vaccination changed in a season when the LAIV was not recommended...
July 28, 2017: Vaccine
Bei Bei, Teresa E Seeman, Judith E Carroll, Joshua F Wiley
Study Objectives: Variable daily sleep (ie, higher intraindividual variability; IIV) is associated with negative health consequences, but potential physiological mechanisms are poorly understood. This study examined how the IIV of sleep timing, duration, and quality is associated with physiological dysregulation, with diurnal cortisol trajectories as a proximal outcome and allostatic load (AL) as a multisystem distal outcome. Methods: Participants are 436 adults (Mage ± standard deviation = 54...
September 1, 2017: Sleep
Abiy Habtewold, Eleni Aklillu, Eyasu Makonnen, Getnet Yimer, Leif Bertilsson, Jürgen Burhenne, Joel S Owen
The objectives of this study were to characterize the population pharmacokinetics (PK) of efavirenz (EFV) and 8-hydroxy-efavirenz (8OHEFV) in plasma and peripheral blood mononuclear cells (PBMCs) and to explore covariates affecting the PK parameters. Fifty-one patients had steady-state 0-to-24-h concentrations of EFV and 8OHEFV in plasma with corresponding concentrations in PBMCs, while 261 patients had one or two sparse concentrations at 16 ± 1 h postdose at weeks 4 and/or 16. The pharmacogenetic markers CYP2B6*6, CYP3A5*3, CYP3A5*6, UGT2B7*2, ABCB1 (3435C→T, 3842A→G), OATP1B1*1B, and OATP1B1*5, the presence of a rifampin-based antituberculosis (anti-TB) regimen, baseline body weight and organ function values, and demographic factors were explored as covariates...
August 2017: Antimicrobial Agents and Chemotherapy
Becky I Haynes, Sarah Bauermeister, David Bunce
OBJECTIVES: Intraindividual variability (IIV) in reaction time refers to the trial-to-trial fluctuations in responding across a given cognitive task. Cross-sectional research suggests that IIV increases with normal and neuropathological ageing and it may serve as a marker of neurobiological integrity. This raises the possibility that IIV may also predict future cognitive decline and, indeed, neuropathology. Therefore, we conducted a systematic review to address these issues. METHODS: A search of electronic databases Embase, Medline, PsycINFO, and Web of Science was completed on May 17, 2016 that identified longitudinal investigations of IIV in middle-aged or older adults...
May 2, 2017: Journal of the International Neuropsychological Society: JINS
Christina D Kay, Michael Seidenberg, Sally Durgerian, Kristy A Nielson, J Carson Smith, John L Woodard, Stephen M Rao
INTRODUCTION: Intraindividual variability (IIV) in motor performance has been shown to predict future cognitive decline. The apolipoprotein E-epsilon 4 (APOE-ε4) allele is also a well-established risk factor for memory decline. Here, we present novel findings examining the influence of the APOE-ε4 allele on the performance of asymptomatic healthy elders in comparison to individuals with amnestic MCI (aMCI) on a fine motor synchronization, paced finger-tapping task (PFTT). METHOD: Two Alzheimer's disease (AD) risk groups, individuals with aMCI (n = 24) and cognitively intact APOE-ε4 carriers (n = 41), and a control group consisting of cognitively intact APOE-ε4 noncarriers (n = 65) completed the Rey Auditory Verbal Learning Test and the PFTT, which requires index finger tapping in synchrony with a visual stimulus (interstimulus interval = 333 ms)...
January 4, 2017: Journal of Clinical and Experimental Neuropsychology
Manel Aouri, Catalina Barcelo, Monia Guidi, Margalida Rotger, Matthias Cavassini, Cédric Hizrel, Thierry Buclin, Laurent A Decosterd, Chantal Csajka
Rilpivirine (RPV), the latest nonnucleoside reverse transcriptase inhibitor active against HIV-1, is prescribed in a standard dosage of 25 mg once a day in combination with emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). The aim of this observational study was to characterize the RPV pharmacokinetic profile, to quantify interpatient variability, and to identify potential factors that could influence drug exposure. RPV concentration data were collected from HIV-infected patients as part of routine therapeutic drug monitoring performed in our center (Laboratory of Clinical Pharmacology)...
January 2017: Antimicrobial Agents and Chemotherapy
Aitor Nogales, Kai Huang, Caroline Chauché, Marta L DeDiego, Pablo R Murcia, Colin R Parrish, Luis Martínez-Sobrido
Canine Influenza Virus (CIV) H3N8 is the causative agent of canine influenza, a common and contagious respiratory disease of dogs. Currently, only inactivated influenza vaccines (IIVs) are available for the prevention of CIV H3N8. However, live-attenuated influenza vaccines (LAIVs) are known to provide better immunogenicity and protection efficacy than IIVs. Influenza NS1 is a virulence factor that offers an attractive target for the preparation of attenuated viruses as LAIVs. Here we generated recombinant H3N8 CIVs containing truncated or a deleted NS1 protein to test their potential as LAIVs...
January 2017: Virology
Victor Mangas-Sanjuan, Sarin Colon-Useche, Isabel Gonzalez-Alvarez, Marival Bermejo, Alfredo Garcia-Arieta
The objective is to compare the performance of dissolution-profile comparison methods when f 2 is inadequate due to high variability. The 90% confidence region of the Mahalanobis distance and the 90% bootstrap confidence interval (CI) of the f 2 similarity factor (f 2-bootstrap) were explored. A modification of the Mahalanobis distance (new D-Mahalanobis) in which those points >85% were not taken into account for calculation was also used. A population kinetic approach in NONMEM was used to simulate dissolution profiles with the first-order or Weibull kinetic models...
November 2016: AAPS Journal
Min Z Levine, Judith M Martin, F Liaini Gross, Stacie Jefferson, Kelly Stefano Cole, Crystal Ann Archibald, Mary Patricia Nowalk, Michael Susick, Krissy Moehling, Sarah Spencer, Jessie R Chung, Brendan Flannery, Richard K Zimmerman
Human influenza A(H3N2) viruses that predominated during the moderately severe 2014-2015 influenza season differed antigenically from the vaccine component, resulting in reduced vaccine effectiveness (VE). To examine antibody responses to 2014-2015 inactivated influenza vaccine (IIV) and live-attenuated influenza vaccine (LAIV) among children and adolescents, we collected sera before and after vaccination from 150 children aged 3 to 17 years enrolled at health care facilities. Hemagglutination inhibition (HI) assays were used to assess the antibody responses to vaccine strains...
October 2016: Clinical and Vaccine Immunology: CVI
Annemieke J M Nieuweboer, Ellen S de Morrée, Anne-Joy M de Graan, Alex Sparreboom, Ronald de Wit, Ron H J Mathijssen
Docetaxel is a frequently used chemotherapeutic agent in the treatment of solid cancers. Because of the large inter-individual variability (IIV) in the pharmacokinetics (PK) of docetaxel, it is challenging to determine the optimal dose in individual patients in order to achieve optimal efficacy and acceptable toxicity. Despite the established correlation between systemic docetaxel exposure and efficacy, the precise factors influencing docetaxel PK are not yet completely understood. This review article highlights currently known factors that influence docetaxel PK, and focusses on those that are clinically relevant...
July 2015: Cancer Treatment Reviews
M J Sanchez
Contents-This report presents national estimates of the prevalance and severity cf periodontal disease among youths aged 12-17 years in the United States according, to race, sex, age, and other selected demographic characteristics. The severity and prevalance of periodontal disease were measured by the Periodontal Index (PI). A correlation analysis of the interrelation of the PI and selected demographic variables is also included. Background and Source of Data-During 1966-70 the Division of Health Examination Statistics conducted a survey of the health uf the Nation's youth...
June 1974: Vital and Health Statistics. Series 11, Data From the National Health Survey
Erin E Morgan, Katie L Doyle, Arpi Minassian, Brook L Henry, William Perry, Thomas D Marcotte, Steven Paul Woods, Igor Grant
Methamphetamine (MA) dependence is associated with executive dysfunction, but no studies have evaluated MA-related elevations in neurocognitive intraindividual variability (IIV), an expression of cognitive dyscontrol linked to poor daily functioning in populations with frontal systems injury. We examined IIV during a vigilance task in a well-characterized sample of 35 MA-dependent (MA+) and 55 non-MA using comparison participants (MA-) as part of a larger neuropsychological battery that included self-report and performance-based measures of everyday functioning...
December 15, 2014: Psychiatry Research
Debjani Das, Xiaoyun Tan, Allison A M Bielak, Nicolas Cherbuin, Simon Easteal, Kaarin J Anstey
Genetic differences play a significant role in generating individual differences in cognitive abilities. Studies have linked common polymorphisms (valine to methionine substitution; VAL/MET) in the catechol-O-methyltransferase (COMT) and brain-derived neurotrophic factor (BDNF) to cognitive differences between individuals. However, not all studies support these associations and hence, the impact of these polymorphisms on cognition is unclear. Here, we investigated the effect of COMT VAL158MET and BDNF VAL66MET polymorphisms and their interaction on cognitive performance measured longitudinally over 8 years in a population-based sample of older adults (60-64 years at baseline; n = 400)...
June 2014: Psychology and Aging
Oneeb Majid, Anubha Gupta, Larisa Reyderman, Martin Olivo, Ziad Hussein
Pharmacometric investigation of eribulin was undertaken in patients with metastatic breast cancer (MBC) and other advanced solid tumors. A population pharmacokinetic (PK) model used data combined from seven phase 1 studies (advanced solid tumors; n = 129), and one phase 2 (MBC; n = 211), and one phase 3 study (MBC; n = 173). Phase 3 data were also used in a PK/pharmacodynamic (PD) model of efficacy and tumor response (sum of longest diameters of target lesions). All analyses used NONMEM 7.2. Eribulin PK, described by a dose-independent, three-compartment model with allometric relationship for body weight, was similar for all tumor types...
October 2014: Journal of Clinical Pharmacology
Erjian Wang, Dongwoo Kang, Kyun-Seop Bae, Margaret A Marshall, Dmitri Pavlov, Kourosh Parivar
Tremelimumab, a fully human monoclonal antibody specific for human cytotoxic T-lymphocyte-associated antigen 4, has been studied in clinical trials. We have reported the results of population pharmacokinetics for tremelimumab in 654 metastatic melanoma patients. Population estimates (inter-individual variability [IIV]) for pharmacokinetic parameters in a final model were clearance (CL), 0.26 L/day (31.8%) and central volume of distribution, 3.97 L (20.4%). CL was faster in males, patients with higher values of creatinine clearance and endogenous immunoglobulin, and patients with relatively poor baseline prognostic factors...
October 2014: Journal of Clinical Pharmacology
Yang He, Janice E Brunstrom-Hernandez, Liu Lin Thio, Shellie Lackey, Deborah Gaebler-Spira, Maxine M Kuroda, Elaine Stashinko, Alexander H Hoon, Jilda Vargus-Adams, Richard D Stevenson, Stephanie Lowenhaupt, John F McLaughlin, Ana Christensen, Nienke P Dosa, Maureen Butler, Aloysia Schwabe, Christina Lopez, Desiree Roge, Diane Kennedy, Ann Tilton, Linda E Krach, Andrew Lewandowski, Hongying Dai, Andrea Gaedigk, J Steven Leeder, William J Jusko
OBJECTIVE: To characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral palsy (CP) in order to support its clinical use. SUBJECTS DESIGN: Children (2-17 years of age) with CP received a dose of titrated oral baclofen from 2.5 mg 3 times a day to a maximum tolerated dose of up to 20 mg 4 times a day. PK sampling followed titration of 10-12 weeks. Serial R- and S-baclofen plasma concentrations were measured for up to 16 hours in 49 subjects...
May 2014: Journal of Pediatrics
Deborah Finkel, Nancy L Pedersen
Intraindividual variability (IIV) in reaction time has been related to cognitive decline, but questions remain about the nature of this relationship. Mean and range in movement and decision time for simple reaction time were available from 241 individuals aged 51-86 years at the fifth testing wave of the Swedish Adoption/Twin Study of Aging. Cognitive performance on four factors was also available: verbal, spatial, memory, and speed. Analyses indicated that range in reaction time could be used as an indicator of IIV...
2014: Neuropsychology, Development, and Cognition. Section B, Aging, Neuropsychology and Cognition
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