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PubMed · 10118456

Biological technical amendment--FDA. Final rule; technical amendment.

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Abstract

The Food and Drug Administration (FDA) is amending the biologics regulations to make a minor, technical amendment. The pressure stated at which a sustained sterilization temperature is attained is incorrect. This document corrects that error.

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Blood Specimen CollectionHumansLaboratoriesSpecimen HandlingSterilizationUnited StatesUnited States Food and Drug AdministrationJournal Article

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1992-04-02. Biological technical amendment--FDA. Final rule; technical amendment.. https://pubmed.ncbi.nlm.nih.gov/10118456/

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Therapeutic drug monitoring of tacrolimus with the dried blood spot method.

In a preliminary investigation an assay for tacrolimus based on fingerprick sampling and consecutive application as a blood spot on sampling paper has been developed. The dried blood spot was analysed by HPLC-tandem mass spectrometry. The validated range was 1-30 microg/l. Intra- and inter-assay variability for precision and accuracy was <7.5% and 15%, respectively. Tacrolimus concentrations of 24 stable out patients were compared after both blood spot sampling and conventional venous sampling. Method agreement was investigated with the methods of Passing and Bablok and Bland Altman and proved suitable for clinical use. The dried blood spot method for tacrolimus seems promising for patient monitoring.

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