Document Detail


Adaptation and performance of an immuno-PCR assay for the quantification of Aviscumine in patient plasma samples.
MedLine Citation:
PMID:  15982849     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
An immuno-polymerase chain reaction (IPCR) assay is used to evaluate the kinetic behaviour of the novel anti-cancer drug Aviscumine in plasma samples taken from 41 patients during a 3-year clinical trial. The ultrasensitive IPCR assay employed the amplification of a detection-antibody linked marker-DNA and an internal competitor DNA for standardization, thus enabling the detection of the antigen in concentrations far below the detection limit of conventional enzyme-linked immuno-sorbent assay (ELISA). The quantification of Aviscumine was carried out using external calibration curves obtained from individual patient plasma samples, collected previous to the administration of Aviscumine, which were spiked with known amounts of the reference substance Aviscumine. Additional controls were measured containing standardized human serum spiked with Aviscumine to assure the continuous general reproducibility of the assay as well as to estimate differences between individual patients. Average recovery was found to be 95+/-19% and the average deviation in precision of the assay was determined to be 9+/-5%. Data for the quantification of Aviscumine were obtained from all patient samples investigated with the exception of a single patient. The collected data provided the basis for the valid routine quantification of patient samples for the calculation of the pharmacokinetic behaviour of Aviscumine in patient plasma.
Authors:
Michael Adler; Martin Langer; Klaus Witthohn; Karin Wilhelm-Ogunbiyi; Patrick Schöffski; Pierre Fumoleau; Christof M Niemeyer
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Publication Detail:
Type:  Journal Article     Date:  2005-06-27
Journal Detail:
Title:  Journal of pharmaceutical and biomedical analysis     Volume:  39     ISSN:  0731-7085     ISO Abbreviation:  J Pharm Biomed Anal     Publication Date:  2005 Oct 
Date Detail:
Created Date:  2005-10-14     Completed Date:  2006-02-08     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8309336     Medline TA:  J Pharm Biomed Anal     Country:  England    
Other Details:
Languages:  eng     Pagination:  972-82     Citation Subset:  IM    
Affiliation:
Chimera Biotec GmbH, Emil-Figge-Str. 76 A, D-44227 Dortmund, Germany. adler@chimera-biotec.com
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MeSH Terms
Descriptor/Qualifier:
Algorithms
Calibration
Humans
Immunoassay
Plant Preparations / blood*
Plant Proteins / blood*
Reproducibility of Results
Reverse Transcriptase Polymerase Chain Reaction
Ribosome Inactivating Proteins, Type 2
Toxins, Biological / blood*
Chemical
Reg. No./Substance:
0/Plant Preparations; 0/Plant Proteins; 0/Ribosome Inactivating Proteins, Type 2; 0/Toxins, Biological; 0/ribosome inactivating protein, Viscum

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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