Journal ArticleDOI
Validation of liquid chromatographic and gas chromatographic methods. Applications to pharmacokinetics.
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TLDR
This manuscript is intended to provide guiding principles for the evaluation of a method's overall performance, including sampling procedure, sample preparation, chromatographic separation, detection and data evaluation, and models used for analytical calibration curves are explained in term of validity and limitations.About:
This article is published in Journal of Chromatography B: Biomedical Sciences and Applications.The article was published on 1996-11-08. It has received 349 citations till now.read more
Citations
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Journal ArticleDOI
Accumulation of trimethylamine and trimethylamine- N -oxide in end-stage renal disease patients undergoing haemodialysis
TL;DR: TMA and TMNO accumulate between haemodialysis sessions in ESRD patients, but are efficiently removed during a single haemmodialysis session.
Journal ArticleDOI
Quantitative determination of endogenous compounds in biological samples using chromatographic techniques
TL;DR: In this paper, the advantages and disadvantages of using the authentic analyte in a surrogate matrix and the use of a surrogate analyte on the authentic matrix are compared, and the authors highlight important aspects of validation of chromatographic methods for endogenous analytes.
Journal ArticleDOI
Bioanalytical chromatographic method validation according to current regulations, with a special focus on the non-well defined parameters limit of quantification, robustness and matrix effect.
Oskar González,María Encarnación Blanco,Gorka Iriarte,L. Bartolomé,M.I. Maguregui,Rosa M. Alonso +5 more
TL;DR: The overall validation process including common validation parameters (selectivity, linearity range, precision, accuracy, stability…) will be reviewed, the most controversial parameters (limit of quantification, robustness and matrix effect) will be carefully studied and the definitions and methodology proposed by the different regulatory bodies will be compared.
Book ChapterDOI
Bioanalytical method validation and its implications for forensic and clinical toxicology – A review
Frank T. Peters,Hans H. Maurer +1 more
TL;DR: In this review, the most important papers published on this topic since 1991 have been reviewed and Terminology, theoretical and practical aspects as well as implications for forensic and clinical toxicology of the following validation parameters are discussed.
Journal ArticleDOI
Bioanalytical liquid chromatographic method validation. a review of current practices and procedures
TL;DR: In this article, a survey of recent literature on liquid chromatographic procedures used in the bioanalysis of anticancer drugs revealed that very variable standards were employed for validation, and the authors provided practical approaches for determining selectivity, specificity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness.
References
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Journal ArticleDOI
Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies
Vinod P. Shah,Kamal K. Midha,Shrikant Dighe,Iain J. McGilveray,Jerome P. Skelly,Avraham Yacobi,Thomas Layloff,C. T. Viswanathan,C. Edgar Cook,R. D. McDowall,Kenneth A. Pittman,Sidney Spector +11 more
TL;DR: The report presents the assessment of the major agreements and issues discussed at the conference onAnalytical Methods Validation to provide guiding principles for validation of analytical methods used in bioavailability, bioequivalence, and pharmacokinetics studies in humans and animals.
Journal ArticleDOI
Validation of bioanalytical methods.
TL;DR: This Review puts the various techniques into perspective and discusses pitfalls which may occur in interpretation of validation data, as well as explaining models used for analytical calibration curves in terms of their validity and limitations.
Journal ArticleDOI
A practical approach to method validation in pharmaceutical analysis.
G.P. Carr,J.C. Wahlich +1 more
TL;DR: It is attempted to suggest some practical approaches to conducting validation and in particular to the determination of accuracy, linearity and limit of detection/quantitation.
Journal ArticleDOI
Application issues in bioanalytical method validation, sample analysis and data reporting
TL;DR: Application issues concerning prerequisites to method validation, and all validation criteria for evaluation of method reliability and overall performance, are discussed.
Journal ArticleDOI
Method validation in the bioanalytical laboratory
TL;DR: Bioanalytical methods, based on a variety of physico-chemical and biological techniques such as chromatography, immunoassay and mass spectrometry, must be validated prior to and during use to engender confidence in the results generated.