Assessment of Whole Blood Stability and Blood/Plasma Distribution of Drugs

Love, Iain; Smith, G.S.; Hill, Howard

doi:10.1002/9781118671276.ch12

Cited by 6 publications

(1 citation statement)

References 26 publications

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“…However, it is important to consider other sources. Recently, instability of investigational compounds has been noted due to a pH shift in biological fluids, and from the adsorption of compounds to containers/ catheters during sample collection and storage (Bashaw et al, 2014;Fura, Harper, Zhang, Fung, & Shyu, 2003;Love, Smith, & Hill, 2013;Shaolian, Qi, Yong, & Weng, 2005;Whitmire et al, 2011).…”

Section: Instability Of the Analyte And Its Metabolites During Collmentioning

confidence: 99%

Hazards in chromatographic bioanalysis method development and applications

Hooshfar

Bartlett

2016

Biomedical Chromatography

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Bioanalytical methods are employed for the quantitative determination of drugs and their metabolites in biological matrices, in all stages of the drug development process. However, because of the highly complex nature of these matrices there is a wide range of potential biological, chemical and physical hazards that can influence the quality of the data produced by these methods. The present review focuses on the evaluation of the most important and frequent errors that may be encountered during bioanalytical method development/validation and analysis of clinical or preclinical samples mainly using chromatography. Additionally, the most practical ways for avoiding and managing these hazards during routine bioanalysis are presented.

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Section: Instability Of the Analyte And Its Metabolites During Collmentioning

confidence: 99%

Hazards in chromatographic bioanalysis method development and applications

Hooshfar

Bartlett

2016

Biomedical Chromatography

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Incurred Sample Reanalysis of Fingolimod and Fingolimod Phosphate in Blood: Stability Evaluation and Application to A Rat Pharmacokinetic Study

et al. 2017

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Whole Blood Stability in Quantitative Bioanalysis

et al. 2019

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Establishing stability at all stages of a sample’s lifespan is a critical part of performing regulated bioanalysis. For plasma assays, this includes the duration between when blood is drawn and when that blood is centrifuged to produce plasma. Here, we provide a discussion of current regulatory expectations around whole blood stability testing for LC–MS plasma assays, as well as the two primary experimental approaches utilized to assess whole blood stability. Next, we interrogated a large dataset of validated methods (1076 methods, the vast majority of which were for measurement of small molecules) to assess the correlation between whole blood and plasma stability profiles, finding them to be highly correlated. Finally, we summarize unique case studies; we have encountered during WB stability testing which offer lessons that may be broadly applicable.

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Assessment of Whole Blood Stability and Blood/Plasma Distribution of Drugs

Cited by 6 publications

References 26 publications

Hazards in chromatographic bioanalysis method development and applications

Hazards in chromatographic bioanalysis method development and applications

Incurred Sample Reanalysis of Fingolimod and Fingolimod Phosphate in Blood: Stability Evaluation and Application to A Rat Pharmacokinetic Study

Whole Blood Stability in Quantitative Bioanalysis

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