2011
DOI: 10.4155/bio.11.163
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Aspects of Bioanalytical Method Validation for the Quantitative Determination of Trace Elements

Abstract: Bioanalytical methods are used to quantitatively determine the concentration of drugs, biotransformation products or other specified substances in biological matrices and are often used to provide critical data to pharmacokinetic or bioequivalence studies in support of regulatory submissions. In order to ensure that bioanalytical methods are capable of generating reliable, reproducible data that meet or exceed current regulatory guidance, they are subjected to a rigorous method validation process. At present, … Show more

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Cited by 13 publications
(9 citation statements)
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“…This technique allows precise quantification of the gold ion content in biological samples. 43 The uptake of citrate-GNS by B cells was confirmed, with approximately 10 μg of gold measured per 10 6 cells (calculated by dividing measured GNP mass per total cell count and multiplying by 10 6 ) ( Figure 3B). This corresponds to approximately 1% GNP-B cell association as a function of measured GNP mass per total exposed GNP mass.…”
Section: Gnps With Different Polymer Coatings and Shapesmentioning
confidence: 77%
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“…This technique allows precise quantification of the gold ion content in biological samples. 43 The uptake of citrate-GNS by B cells was confirmed, with approximately 10 μg of gold measured per 10 6 cells (calculated by dividing measured GNP mass per total cell count and multiplying by 10 6 ) ( Figure 3B). This corresponds to approximately 1% GNP-B cell association as a function of measured GNP mass per total exposed GNP mass.…”
Section: Gnps With Different Polymer Coatings and Shapesmentioning
confidence: 77%
“…To quantify the uptake of GNPs with human B cells and to compare this to the association by other APCs, we measured the gold content within B cells and MDMs after exposure to 20 μg/mL of GNPs by using inductively coupled plasma mass spectroscopy (ICP-MS). This technique allows precise quantification of the gold ion content in biological samples . The uptake of citrate-GNS by B cells was confirmed, with approximately 10 μg of gold measured per 10 6 cells (calculated by dividing measured GNP mass per total cell count and multiplying by 10 6 ) (Figure B).…”
Section: Resultsmentioning
confidence: 99%
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“…Therefore, regardless of the atomic spectrometric technique, an increasingly global economy will place greater emphasis on the development and validation of rugged bioanalytical methods that are compliant with harmonized Guidance and are readily transferable to CROs in several countries. The approach to validating elemental analytical methods in biological systems is described in the article by Levine et al in this issue [15].…”
Section: Validating Icp-ms/oes Bioanalytical Methodsmentioning
confidence: 99%
“…In order to draw sound scientific conclusions from bioanalysis research projects, it is important to have a robust validated analytical method. [6,7] While some methods may focus on the analysis of a single analyte to investigate causal relationships between the analyte and the health outcome, biological systems are often more complicated and require multifactorial analyses to elucidate the complex interrelationships of a broad panel of analytes, or “-omics” type approaches. “Metallomics” is an encompassing term for the study of metals and their function in cells that has seen increased visibility and attention in recent years.…”
Section: Introductionmentioning
confidence: 99%