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Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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A comprehensive quality control system suitable for academic research: application in a pediatric study.

Nina Makowski1, Agnes M Ciplea1, Mohsin Ali1

  • 1Institute of Clinical Pharmacy & Pharmacotherapy, Heinrich Heine University, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.

Bioanalysis
|March 5, 2020
PubMed
Summary

This study developed a quality control system for academic pediatric research, ensuring reliable aldosterone measurements. The system enhances bioanalytical data quality for clinical studies.

Keywords:
academic researchaldosteroneincurred sample reanalysisligand-binding assaypediatric clinical trialquality control system

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Area of Science:

  • Pediatric Clinical Research
  • Bioanalytical Chemistry
  • Assay Development and Validation

Background:

  • Academic-initiated pediatric clinical research requires robust bioanalytical data quality assurance.
  • Existing guidance for bioanalytical quality monitoring in academic settings is insufficient.
  • Reliability of pharmacodynamic measures depends heavily on accurate bioanalytical data.

Purpose of the Study:

  • To develop and evaluate a comprehensive bioanalytical quality control system for academic research.
  • To ensure the reliability of aldosterone measurements in pediatric samples.
  • To provide guidance for bioanalytical quality monitoring in academic environments.

Main Methods:

  • A five-step quality control system was designed based on regulatory guidelines and scientific recommendations.
  • The system included performance qualification, calibration curve evaluation, intra- and inter-run analysis, incurred sample reanalysis, and external quality assessment.
  • The system was applied to monitor the immunoassay-based bioanalysis of aldosterone over 29 months.

Main Results:

  • A total of 55 out of 70 analytical runs were qualified for aldosterone quantification.
  • The system enabled the reliable evaluation of 954 pediatric samples.
  • The bioanalytical method demonstrated consistent reliability throughout the 29-month study period.

Conclusions:

  • The developed bioanalytical quality control system effectively monitored aldosterone assay performance.
  • The system proved applicable and beneficial within the academic research environment.
  • This approach enhances the quality and reliability of bioanalytical data in pediatric studies.