Fluorescence polarization immunoassay: Does it always represent a reliable method to monitor treatment with teicoplanin?: Comparison with data obtained by high-performance liquid chromatography

Bourget, Philippe; Lesne-Hulin, A.; Sertin, A.; Maillot, A.; Alaya, M.; Martin, Claudio M.

doi:10.1016/s0378-5173(96)04797-7

Cited by 11 publications

(6 citation statements)

References 8 publications

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“…The differences in concentrations obtained between FPIA and HPLC are well known [17,18] and, as occurred in our study, are systematically in favor of FPIA that gives higher concentrations than HPLC. FPIA is an immunoassay that uses sheep antibodies.…”

Section: Discussionsupporting

confidence: 75%

Group A2 Analogs of Innovator Teicoplanin: Variability of their Ratio during Treatment Time Course in Human Blood; Consequences for the Generics

P¹

2013

Pharmaceut Reg Affairs

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Absence of therapeutic equivalence (TE) of generic antibiotics versus the innovator has been reported, even in case of pharmaceutical equivalence (PE).The pharmaceutically active principle of teicoplanin is mainly represented by the A2 group analogs (A2-1 to A2-2) which exist in given ratios in the innovator.We studied the evolution of these ratios in humans volunteers receiving 2 dosage regimen (6mg/kg IV every 12 hours, 3 times, and then 6 mg/kg per day for ten days -group1-, and 12 mg/kg IV every 12h, 3 times, followed by 15 mg/kg every other day till D11 -group 2-), by a specific HPLC methodology, after single dose (D1) and at steady state at day 11(D11).The less lipophilic analogs A2-1, A2-2, and A2-3 percentage decreases respectively were 18%, 11%, and 21% (group 1) and 34%, 14%, and 15% (group 2) between D1 and D11 for trough concentrations. At the same time, the more lipophilic A2-4 and A2-5 analogs ratio increases respectively were 15% and 19% (group 1) and 13% and 30% (group 2). These variations raise the problem of generics having the same global qualitative composition of analogs (PE) but with differing initial ratios. The bactericidal activity of innovator teicoplanin is optimal at its own ratios of the different analogs that act in a synergistic manner. Regarding generics, it would lead to final ratio in blood and tissues that are at risk of a sub optimal bactericidal activity. Thus, concluding in bioequivalence and therapeutic equivalence of these generics with the innovator remains highly questionable.

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Section: Discussionsupporting

confidence: 75%

Group A2 Analogs of Innovator Teicoplanin: Variability of their Ratio during Treatment Time Course in Human Blood; Consequences for the Generics

P¹

2013

Pharmaceut Reg Affairs

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“…[ 49]. FPIA is the most convenient method, but it may not be accurate at low concentrations [ 51]. Therapeutic drug monitoring of teicoplanin is performed occasionally to ensure efficacy.…”

Section: Teicoplaninmentioning

confidence: 99%

The therapeutic monitoring of antimicrobial agents

Begg

Barclay

Kirkpatrick

1999

Brit J Clinical Pharma

146

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Aims To review the basis and optimal use of therapeutic drug monitoring of antimicrobial agents. Methods Antimicrobial agents for which a reasonable case exists for therapeutic drug monitoring were reviewed under the following headings: pharmacokinetics, why monitor, therapeutic range, individualisation of therapy, sampling times, methods of analysis, interpretative problems and cost‐effectiveness of monitoring. Results There is a strong historical case for monitoring aminoglycosides. The recent move to once‐daily dosing means that criteria for therapeutic drug monitoring need to be redefined. Vancomycin has been monitored routinely but many questions remain about the most appropriate approach to this. A case can be made for monitoring teicoplanin, flucytosine and itraconazole in certain circumstances. Conclusions The approach to monitoring aminoglycosides needs to be redefined in the light of once‐daily dosing. It is premature to suggest that less stringent monitoring is necessary as toxicity remains a problem with these drugs. The ideal method of monitoring vancomycin remains to be defined although a reasonable case exists for measuring trough concentrations, mainly to ensure efficacy. Teicoplanin is monitored occasionally to ensure efficacy while flucytosine is monitored occasionally to avoid high concentrations associated with toxicity. Itraconazole has various pharmacokinetic problems and monitoring has been suggested to ensure that adequate concentrations are achieved.

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“…The general disadvantage of immunoassays used for TDM is their susceptibility to interferences and cross-reactions. In addition and Brought to you by | University of Georgia Libraries Authenticated Download Date | 5/27/15 9:51 AM more specifically, teicoplanin immunoassays have been reported to suffer from high imprecision especially at low concentrations around 10 mg/L which is the clinical decision cut-off [22]. To overcome these problems, alternative methods may be used, e.g., chromatography techniques.…”

Section: Discussionmentioning

confidence: 99%

Quantification of teicoplanin in plasma by LC-MS with online sample clean-up and comparison with QMS® assay

Müller

Eckardstein

Saleh

2014

Clinical Chemistry and Laboratory Medicine (CCLM)

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Fluorescence polarization immunoassay: Does it always represent a reliable method to monitor treatment with teicoplanin?: Comparison with data obtained by high-performance liquid chromatography

Cited by 11 publications

References 8 publications

Group A2 Analogs of Innovator Teicoplanin: Variability of their Ratio during Treatment Time Course in Human Blood; Consequences for the Generics

Group A2 Analogs of Innovator Teicoplanin: Variability of their Ratio during Treatment Time Course in Human Blood; Consequences for the Generics

The therapeutic monitoring of antimicrobial agents

Quantification of teicoplanin in plasma by LC-MS with online sample clean-up and comparison with QMS® assay

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