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Invasiveness of pharmacokinetic studies in children: a systematic review

Mohammed I Altamimi1, Imti Choonara1, Helen Sammons1

  • 1Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.

BMJ Open
|July 20, 2016
PubMed

Insights

Pharmacokinetic (PK) studies in children show an increase in blood samples from 1985-1995, followed by a decline. Population PK methods reduce blood sampling frequency in pediatric pharmacokinetic research.

Area of Science:

  • Pharmacology
  • Pediatric Research
  • Clinical Trials

Background:

  • Pharmacokinetic (PK) studies are crucial for understanding drug behavior in children.
  • Assessing the invasiveness of pediatric PK studies is important for patient well-being.
  • Evaluating trends in sample collection over time can inform best practices.

Purpose of the Study:

  • To determine if pharmacokinetic (PK) studies in pediatric patients are becoming less invasive.
  • To analyze trends in the number and volume of blood samples collected in pediatric PK studies over four decades.

Main Methods:

  • A systematic literature review was conducted.
  • PK studies involving children aged 0-18 years were identified.
  • Data on the number and volume of blood samples collected were extracted and analyzed across four decades (1974-2015).

Main Results:

  • A total of 549 studies were analyzed from 1974 to 2015.
  • The number of blood samples per participant increased from 1986-1995 but decreased in subsequent decades.
  • No significant changes were observed in the volume of blood collected per sample or total volume per child.
  • Population PK studies utilized fewer blood samples compared to non-population PK studies.

Conclusions:

  • The number of blood samples in pediatric PK studies increased and then decreased over the analyzed period.
  • The total volume of blood collected per child in PK studies remained consistent over four decades.
  • Population PK methodologies contribute to less frequent blood sampling in pediatric pharmacokinetic research.
Abstract

Keywords:
BloodChildrenPharmacokineticsSampling

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