Evidence map›Paper›PMID 18771484›Full record

ArticleBritish journal of clinical pharmacology2008

Population pharmacokinetic analysis for risperidone using highly sparse sampling measurements from the CATIE study.

Yan Feng, Bruce G Pollock, Kim Coley, Stephen Marder, Del Miller, Margaret Kirshner, Manickam Aravagiri, Lon Schneider, Robert R Bies

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02294448 (Population Pharmacokinetic Modeling of Qishe Pill in Three Major TCM-defined Constitutional Types of Healthy Chinese Subjects), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
4.0field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02294448 phase1unknown statusnot on this mapstarted 2014, after this paper: background citation

Population Pharmacokinetic Modeling of Qishe Pill in Three Major TCM-defined Constitutional Types of Healthy Chinese Subjects: Study Protocol for a Phase I Clinical Trial

TypeinterventionalSponsorShanghai University of Traditional Chinese MedicineRan2014 to 2016Enrolled36ConditionsIndividuality, Narrative MedicineArmsQishe Pill
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 87 citations in OpenAlex.

  1. Paliperidone for schizophrenia.The Cochrane database of systematic reviews · 2008
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 4 countries.

Yan FengStrategic Modeling and Simulation Group, Bristol-Myers Squibb Co., Princeton, NJ, USA.
Bruce G Pollock
Kim Coley
Stephen Marder
Del Miller
Margaret Kirshner
Manickam Aravagiri
Lon Schneider
Robert R Bies
Centre for Addiction and Mental Health · CAUniversity of California, Los Angeles · USBristol-Myers Squibb (Germany) · DEUniversity of Iowa · USUniversity of Pittsburgh · USUniversity of Southern California · US

Funding

PUBLIC EDUCATION CAMPAIGN ON DEPRESSION DARTN01MH090001 · NIMH · UNIVERSITY OF NORTH CAROLINA CHAPEL HILL · 1989 to 2003
$10.4M
MHCRC FOR THE STUDY OF LATE LIFE MOOD DISORDERSP30MH052247 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REYNOLDS, CHARLES F · 1995 to 2004
$7.5M
Atypical Antipsychotics: Determinants of ConcentrationR01MH064173 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI POLLOCK, BRUCE G · 2001 to 2004
$1.1M
Geropsychopharmacology: Enhancing Benefit, Reducing RiskK24MH065416 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI POLLOCK, BRUCE G · 2002 to 2006
$616k
NIMH NIH HHS K24 MH065416NIMH NIH HHS MH52247NIMH NIH HHS MH64173NIMH NIH HHS MH65416NIMH NIH HHS N01 MH090001NIMH NIH HHS P30 MH052247NIMH NIH HHS R01 MH064173
6 · The paper itself

Abstract

aimsTo characterize pharmacokinetic (PK) variability of risperidone and 9-OH risperidone using sparse sampling and to evaluate the effect of covariates on PK parameters.

methodsPK analysis used plasma samples collected from the Clinical Antipsychotic Trials of Intervention Effectiveness. A nonlinear mixed-effects model was developed using NONMEM to describe simultaneously the risperidone and 9-OH risperidone concentration-time profile. Covariate effects on risperidone and 9-OH risperidone PK parameters were assessed, including age, weight, sex, smoking status, race and concomitant medications.

resultsPK samples comprised 1236 risperidone and 1236 9-OH risperidone concentrations from 490 subjects that were available for analysis. Ages ranged from 18 to 93 years. Population PK submodels for both risperidone and 9-OH risperidone with first-order absorption were selected to describe the concentration-time profile of risperidone and 9-OH risperidone. A mixture model was incorporated with risperidone clearance (CL) separately estimated for three subpopulations [poor metabolizer (PM), extensive metabolizer (EM) and intermediate metabolizer (IM)]. Age significantly affected 9-OH risperidone clearance. Population parameter estimates for CL in PM, IM and EM were 12.9, 36 and 65.4 l h(-1) and parameter estimates for risperidone half-life in PM, IM and EM were 25, 8.5 and 4.7 h, respectively.

conclusionsA one-compartment mixture model with first-order absorption adequately described the risperidone and 9-OH risperidone concentrations. Age was identified as a significant covariate on 9-OH risperidone clearance in this study.

Indexed as

AdultAgedAge FactorsAlzheimer DiseaseAntipsychotic AgentsBiological AvailabilityBody WeightFemaleHumansIsoxazolesMaleMetabolic Clearance RateMiddle AgedModels, ChemicalModels, StatisticalPaliperidone PalmitateAntipsychotic AgentsIsoxazolesPaliperidone PalmitatePyrimidinesRisperidone

Identifiers

PMID18771484
PMCPMC2661978
OpenAlexW1972676137

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.