PubTransformer

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PMID- 28419164
OWN - NLM
STAT- In-Process
DA  - 20170418
LR  - 20170418
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 12
IP  - 4
DP  - 2017
TI  - Population pharmacokinetic modelling of rupatadine solution in 6-11 year olds and
      optimisation of the experimental design in younger children.
PG  - e0176091
LID - 10.1371/journal.pone.0176091 [doi]
AB  - AIMS: To optimise a pharmacokinetic (PK) study design of rupatadine for 2-5 year 
      olds by using a population PK model developed with data from a study in 6-11 year
      olds. The design optimisation was driven by the need to avoid children's
      discomfort in the study. METHODS: PK data from 6-11 year olds with allergic
      rhinitis available from a previous study were used to construct a population PK
      model which we used in simulations to assess the dose to administer in a study in
      2-5 year olds. In addition, an optimal design approach was used to determine the 
      most appropriate number of sampling groups, sampling days, total samples and
      sampling times. RESULTS: A two-compartmental model with first-order absorption
      and elimination, with clearance dependent on weight adequately described the PK
      of rupatadine for 6-11 year olds. The dose selected for a trial in 2-5 year olds 
      was 2.5 mg, as it provided a Cmax below the 3 ng/ml threshold. The optimal study 
      design consisted of four groups of children (10 children each), a maximum
      sampling window of 2 hours in two clinic visits for drawing three samples on day 
      14 and one on day 28 coinciding with the final examination of the study.
      CONCLUSIONS: A PK study design was optimised in order to prioritise avoidance of 
      discomfort for enrolled 2-5 year olds by taking only four blood samples from each
      child and minimising the length of hospital stays.
FAU - Santamaria, Eva
AU  - Santamaria E
AD  - Clinical Development, R&D, J. Uriach y Compania, S.A., Barcelona, Spain.
AD  - Departament de Farmacologia, de Terapeutica i de Toxicologia, Universitat
      Autonoma de Barcelona, Barcelona, Spain.
FAU - Estevez, Javier Alejandro
AU  - Estevez JA
AD  - Departament de Farmacologia, de Terapeutica i de Toxicologia, Universitat
      Autonoma de Barcelona, Barcelona, Spain.
AD  - Pharmacokinetic/Pharmacodynamic Modeling and Simulation, CIM-St Pau, Institut de 
      Recerca de l'Hospital de la Santa Creu i Sant Pau-IIB Sant Pau, Barcelona, Spain.
FAU - Riba, Jordi
AU  - Riba J
AD  - Human Neuropsychopharmacology Group, CIM-St Pau, Institut de Recerca de
      l'Hospital de la Santa Creu i Sant Pau-IIB Sant Pau, Barcelona, Spain.
FAU - Izquierdo, Inaki
AU  - Izquierdo I
AD  - Clinical Development, R&D, J. Uriach y Compania, S.A., Barcelona, Spain.
FAU - Valle, Marta
AU  - Valle M
AUID- ORCID: http://orcid.org/0000-0002-3515-251X
AD  - Departament de Farmacologia, de Terapeutica i de Toxicologia, Universitat
      Autonoma de Barcelona, Barcelona, Spain.
AD  - Pharmacokinetic/Pharmacodynamic Modeling and Simulation, CIM-St Pau, Institut de 
      Recerca de l'Hospital de la Santa Creu i Sant Pau-IIB Sant Pau, Barcelona, Spain.
LA  - eng
PT  - Journal Article
DEP - 20170418
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
EDAT- 2017/04/19 06:00
MHDA- 2017/04/19 06:00
CRDT- 2017/04/19 06:00
PHST- 2017/02/07 [received]
PHST- 2017/04/05 [accepted]
AID - 10.1371/journal.pone.0176091 [doi]
AID - PONE-D-17-04950 [pii]
PST - epublish
SO  - PLoS One. 2017 Apr 18;12(4):e0176091. doi: 10.1371/journal.pone.0176091.
      eCollection 2017.

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