Standardization of therapeutic, urinary gonadotrophins: an update on the use and availability of International Standards for Menotrophin.
The potencies of therapeutic preparations of gonadotrophins of human, urinary origin, which comprise a heterogenous mix of isoforms with follicle-stimulating hormone (FSH) and luteinizing hormone (LH) bioactivities, are standardized by WHO International Standards (IS). We report here, the evaluation, through an international collaborative study, of a candidate preparation, coded 10/286, to replace the 4th IS, 98/704, for human, urinary FSH and LH (Menotrophin) which has been used for many years for the potency assignment of therapeutic preparations using bioassays. The mean FSH and LH bioactivities of 10/286, determined by in vivo bioassays in terms of 98/704, were 183 IU per ampoule (95% confidence limits 165-202) and 177 IU per ampoule (95% confidence limits 159-197), respectively.
Endocrinology Section, Biotherapeutics Group, National Institute of Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK. Electronic address: Jackie.Ferguson@nibsc.org.
Jackie
J
Ferguson
Jason
J
Hockley
Richard
R
Tiplady
Chris
C
Burns
D001681:Biological Assay / Q000379:methods / Q000592:standards; D005260:Female; D005300:Fertility Agents, Female / Q000592:standards / Q000627:therapeutic use / Q000652:urine; D005640:Follicle Stimulating Hormone / Q000592:standards* / Q000627:therapeutic use / Q000652:urine; D006801:Humans; D007391:International Cooperation; D007986:Luteinizing Hormone / Q000592:standards* / Q000627:therapeutic use / Q000652:urine; D008596:Menotropins / Q000592:standards* / Q000627:therapeutic use / Q000652:urine; D012015:Reference Standards; D014944:World Health Organization
D005300:Fertility Agents, Female; D008596:Menotropins; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone
Collaborative study; FSH; Follicle-stimulating hormone; Human menopausal gonadotrophin; IRP; IS; IU; International Reference Preparation; International Standard; International Unit; LH; Luteinizing hormone; Menotrophin; follicle-stimulating hormone; luteinizing hormone