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      International Standards for Growth Hormone

      Hormone Research in Paediatrics

      S. Karger AG

      Growth hormone, Immunoassay, Standardization, Quality assessment, International Standard

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          Abstract

          Since 1955, with the establishment by the World Health Organization of the first International Standard (IS) for bovine growth hormone (GH) for bioassay, there have been a number of developments in the standardization of GH. Two GH ISs are in current use: the IS for human GH established in 1982 and the IS for somatropin (recombinant DNA-derived GH) established in 1994. The availability of two such standards does not encourage reproducibility of GH estimates between different laboratories. The author proposes that the international validation and adoption of the IS for somatropin, which has the advantage of an internationally agreed specific activity of 3 IU/mg, as the primary reference standard for all GH immunoassays would finally eliminate this source of variation in GH estimates.

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          The International Standard for Human Growth Hormone for Bioassay: calibration and characterization by international collaborative study.

          Two preparations of human growth hormone (hGH) were prepared as candidates for the International Standard for Human Growth Hormone for Bioassay and were studied by 22 laboratories in 10 countries in an international collaborative study. The 2 candidate preparations, freeze-dried in ampoules coded 80/505 and 80/521, were assayed against the International Standard for Growth Hormone, bovine, for Bioassay (ISbGH), by in vivo assays; against the International Reference Preparation of Growth Hormone, human, for Immunoassay (IRP hGH), by receptor-, immunoassays and other in vitro methods; and against each other by various methods. Both preparations contained the 2 recognized main growth hormone components (22 kDa and 20 kDa forms) and other components, but that in ampoules coded 80/505 had less deamidated hGH and contaminant hormones and pyrogen than that in ampoules coded 80/521. The estimates by in vivo bioassays, using immature hypophysectomized rats, of the potency of 80/505 in terms of the IS bGH were heterogeneous (1-6 IU/ampoule), probably because of the dissimilarity of the preparations of bovine and human GH. Estimates with receptor- and immunoassays of 80/505 against the IRP hGH were also heterogeneous (3-9 IU/ampoule). Nevertheless, the majority of estimates from all assays tended to be between 3 and 6 IU/ampoule. Although 80/521 and 80/505 differed in relatively minor respects, assays of one directly against the other gave relative potency estimates with in vivo assays which were significantly different from estimates with in vitro methods. With the agreement of the participants in the study, the WHO Expert Committee on Biological Standardization established the preparation in ampoules coded 80/505 as the First International Standard for Human Growth Hormone for Bioassay, with the defined potency of 4.4 IU/ampoule. This corresponds to an approximate 2.5 IU/mg of hGH extract and maintains reasonable continuity of the unit.
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            Author and article information

            Journal
            HRE
            Horm Res Paediatr
            10.1159/issn.1663-2818
            Hormone Research in Paediatrics
            S. Karger AG
            978-3-8055-6898-2
            978-3-318-00450-2
            1663-2818
            1663-2826
            1999
            June 1999
            17 November 2004
            : 51
            : Suppl 1
            : 7-12
            Affiliations
            National Institute for Biological Standards and Control, South Mimms, Potters Bar, UK
            Article
            53129 Horm Res 1999;51(suppl 1):7–12
            10.1159/000053129
            10393485
            © 2004 S. Karger AG, Basel

            Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

            Page count
            Figures: 3, Tables: 3, References: 8, Pages: 6
            Categories
            Standardization of Growth Hormone Measurement

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