A systematic and critical review on bioanalytical method validation using the example of simultaneous quantitation of antidiabetic agents in blood

A systematic and critical review on bioanalytical method validation using the example of simultaneous quantitation of antidiabetic agents in blood

•A systematic review was conducted on validated bioanalytical methods.•The validation process was evaluated according to international recommendations.•Several problems regarding method validation were identified among the articles. A systematic and critical review was conducted on bioanalytical met...

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Published in:Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Vol. 1055-1056; pp. 61 - 71
Main Authors: Fachi, Mariana Millan, Leonart, Letícia Paula, Cerqueira, Letícia Bonancio, Pontes, Flavia Lada Degaut, de Campos, Michel Leandro, Pontarolo, Roberto
Format: Journal Article
Language:English
Published: Netherlands Elsevier B.V 15-06-2017
Subjects:
Animals
Antidiabetic agents
Bioanalytical method
Chemistry Techniques, Analytical - methods
Drug Monitoring - methods
Humans
Hypoglycemic Agents - blood
Reproducibility of Results
Sensitivity and Specificity
Systematic review
Validation
Validation Studies as Topic
Validation
Systematic review
Bioanalytical method
Antidiabetic agents
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Abstract •A systematic review was conducted on validated bioanalytical methods.•The validation process was evaluated according to international recommendations.•Several problems regarding method validation were identified among the articles. A systematic and critical review was conducted on bioanalytical methods validated to quantify combinations of antidiabetic agents in human blood. The aim of this article was to verify how the validation process of bioanalytical methods is performed and the quality of the published records. The validation assays were evaluated according to international guidelines. The main problems in the validation process are pointed out and discussed to help researchers to choose methods that are truly reliable and can be successfully applied for their intended use. The combination of oral antidiabetic agents was chosen as these are some of the most studied drugs and several methods are present in the literature. Moreover, this article may be applied to the validation process of all bioanalytical
AbstractList A systematic and critical review was conducted on bioanalytical methods validated to quantify combinations of antidiabetic agents in human blood. The aim of this article was to verify how the validation process of bioanalytical methods is performed and the quality of the published records. The validation assays were evaluated according to international guidelines. The main problems in the validation process are pointed out and discussed to help researchers to choose methods that are truly reliable and can be successfully applied for their intended use. The combination of oral antidiabetic agents was chosen as these are some of the most studied drugs and several methods are present in the literature. Moreover, this article may be applied to the validation process of all bioanalytical.
•A systematic review was conducted on validated bioanalytical methods.•The validation process was evaluated according to international recommendations.•Several problems regarding method validation were identified among the articles. A systematic and critical review was conducted on bioanalytical methods validated to quantify combinations of antidiabetic agents in human blood. The aim of this article was to verify how the validation process of bioanalytical methods is performed and the quality of the published records. The validation assays were evaluated according to international guidelines. The main problems in the validation process are pointed out and discussed to help researchers to choose methods that are truly reliable and can be successfully applied for their intended use. The combination of oral antidiabetic agents was chosen as these are some of the most studied drugs and several methods are present in the literature. Moreover, this article may be applied to the validation process of all bioanalytical
Author Leonart, Letícia Paula
Cerqueira, Letícia Bonancio
de Campos, Michel Leandro
Fachi, Mariana Millan
Pontes, Flavia Lada Degaut
Pontarolo, Roberto
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  givenname: Letícia Paula
  surname: Leonart
  fullname: Leonart, Letícia Paula
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  givenname: Letícia Bonancio
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  givenname: Flavia Lada Degaut
  surname: Pontes
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  givenname: Michel Leandro
  surname: de Campos
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  givenname: Roberto
  surname: Pontarolo
  fullname: Pontarolo, Roberto
  email: pontarolo@ufpr.br
  organization: Universidade Federal do Paraná, Department of Pharmacy,632 Lothário Meissner Avenue, 80210-170, Curitiba, PR, Brazil
BackLink https://www.ncbi.nlm.nih.gov/pubmed/28445848$$D View this record in MEDLINE/PubMed
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Keywords Validation
Systematic review
Bioanalytical method
Antidiabetic agents
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Snippet •A systematic review was conducted on validated bioanalytical methods.•The validation process was evaluated according to international recommendations.•Several...
A systematic and critical review was conducted on bioanalytical methods validated to quantify combinations of antidiabetic agents in human blood. The aim of...
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SubjectTerms Animals
Antidiabetic agents
Bioanalytical method
Chemistry Techniques, Analytical - methods
Drug Monitoring - methods
Humans
Hypoglycemic Agents - blood
Reproducibility of Results
Sensitivity and Specificity
Systematic review
Validation
Validation Studies as Topic
Title A systematic and critical review on bioanalytical method validation using the example of simultaneous quantitation of antidiabetic agents in blood
URI https://dx.doi.org/10.1016/j.jchromb.2017.04.024
https://www.ncbi.nlm.nih.gov/pubmed/28445848
https://search.proquest.com/docview/1892725122
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