1998
DOI: 10.1677/joe.0.1580097
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Characterisation, calibration and comparison by international collaborative study of international standards for the calibration of therapeutic preparations of FSH

Abstract: Therapeutic preparations of FSH, used primarily for treatment of infertility, are calibrated by in vivo bioassay against international standards (IS) derived from different sources deemed appropriate to their use according to pharmacopoeial monographs. Menotrophins, which have been used for several decades to treat infertility, have been calibrated against the IS for urinary FSH and LH (ISU) but are now being replaced by highly purified urinary FSH or rDNA-derived FSH (rFSH).The aim of this study was to evalua… Show more

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Cited by 12 publications
(6 citation statements)
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“…Instead, gonadotropin assay results were calibrated using specific, prechosen populations, with results being expressed in international units (IU) (World Health Organization Expert Committee on Biological Standardization, 1975;Storring et al, 1976Storring et al, , 1978Storring and Gaines, 1989;Rose et al, 1986). In contrast, contemporary recombinant DNA standards are quantified using absolute units of mass (i.e., grams) (Rose et al, 1986;Rose and Gaines-Das, 1998).…”
Section: Genetic Heterogeneitymentioning
confidence: 99%
“…Instead, gonadotropin assay results were calibrated using specific, prechosen populations, with results being expressed in international units (IU) (World Health Organization Expert Committee on Biological Standardization, 1975;Storring et al, 1976Storring et al, , 1978Storring and Gaines, 1989;Rose et al, 1986). In contrast, contemporary recombinant DNA standards are quantified using absolute units of mass (i.e., grams) (Rose et al, 1986;Rose and Gaines-Das, 1998).…”
Section: Genetic Heterogeneitymentioning
confidence: 99%
“…Although some of the international standards have been used for these assays and may help to decrease interassay variation (124), significant interassay heterogeneity of estimates has been observed in two international collaborative studies (123,125,126). Although some of the international standards have been used for these assays and may help to decrease interassay variation (124), significant interassay heterogeneity of estimates has been observed in two international collaborative studies (123,125,126).…”
Section: A Standards For Fshmentioning
confidence: 99%
“…It is claimed that immunoassays are blind to the carbohydrate content of FSH and while the antigenic sites of FSH do not appear to involve oligosaccharides, it is likely that differences in overall charge resulting from variations in sugar structures could affect antibody binding (232). Certainly there is significant variation in the estimates of activity of the same preparations of FSH by immunoassays (124) that has been observed in a recent WHO international collaborative study (123). Certainly there is significant variation in the estimates of activity of the same preparations of FSH by immunoassays (124) that has been observed in a recent WHO international collaborative study (123).…”
Section: Immunoassaysmentioning
confidence: 99%
“…The combination of bioassays arises when the same or similar experiment is performed by multi-laboratories and multi-centers in the calibration of national/international standards for a particular substance (Rose and Gaines-Das, 1998). With the studies of combination of bioassays, most results appear in Bennett (1962), Armitage (1970), Meisner et al (1986), William (1988), Chen et al (1999), Xiong and Chen (2007), and Chen (2007).…”
Section: Introductionmentioning
confidence: 99%