MARC details
000 -LEADER |
fixed length control field |
02720cam a2200277 4500 |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
International Standard Book Number |
9241208147 |
035 ## - |
-- |
(Sirsi) 9241208147 |
060 ## - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
Classification number |
QW 800 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
911108s1991 1 0 eng |
111 2# - MAIN ENTRY--MEETING NAME |
Meeting name or jurisdiction name as entry element |
WHO Expert Committee on Biological Standardization. |
245 00 - TITLE STATEMENT |
Title |
WHO Expert Committee on Biological Standardization [meeting held in Geneva from 16-23 October 1990] : |
Remainder of title |
forty-first report. |
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
Place of publication, distribution, etc. |
Geneva : |
Name of publisher, distributor, etc. |
World Health Organization, |
Date of publication, distribution, etc. |
1991. |
300 ## - PHYSICAL DESCRIPTION |
Extent |
79 p. |
440 #0 - SERIES STATEMENT/ADDED ENTRY--TITLE |
Title |
WHO technical report series ; |
Volume/sequential designation |
814 |
520 3# - SUMMARY, ETC. |
Summary, etc. |
Records the deliberations and recommendations of an expert committee commissioned by WHO to coordinate a range of research and other activities needed to ensure that biological products conform to international standards of purity, potency, safety, and stability. Addressed to manufacturers, researchers and national control authorities, the report also provides updated information about the availability of international biological standards and reference reagents, which are established by WHO and held and distributed by the four international laboratories for biological standards. The report has three main parts. The first consists of brief comments on a number of topics relevant to the development of international reference materials and the use of different assays in quality control. Topics covered include the need to develop international reference materials for growth factors and cytokines, the urgent need to standardize and improve the reliability of assays for residual DNA, and recommended methods for determining the potency of diphtheria toxoid, antivenoms, oral poliomyelitis vaccine, and live measles vaccine. The second part announces changes in the status of international reference materials for various antibiotics, antibodies, antigens, blood products, endocrinological substances and cytokines. The third and most extensive part includes detailed requirements for the manufacturing and licensing of Haemophilus type b conjugate vaccines and inactivated influenza vaccine. Requirements are intended to help manufacturers and control authorities ensure that these products are safe, reliable, and potent prophylactic or therapeutic agents. The book also establishes guidelines for the quality assurance of pharmaceutical and biological products made using recombinant DNA techniques. |
546 ## - LANGUAGE NOTE |
Language note |
eng fre spa rus. |
550 ## - ISSUING BODY NOTE |
Issuing body note |
WHODOC |
561 ## - OWNERSHIP AND CUSTODIAL HISTORY |
History |
WHO monograph |
596 ## - |
-- |
4 |
650 02 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Biological products |
General subdivision |
standards. |
690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) |
Topical term or geographic name as entry element |
Pharmaceuticals and Biologicals. |
710 2# - ADDED ENTRY--CORPORATE NAME |
Corporate name or jurisdiction name as entry element |
World Health Organization. |
856 ## - ELECTRONIC LOCATION AND ACCESS |
Uniform Resource Identifier |
<a href="https://apps.who.int/iris/">https://apps.who.int/iris/</a> |
856 ## - ELECTRONIC LOCATION AND ACCESS |
Uniform Resource Identifier |
<a href="https://apps.who.int/iris/">https://apps.who.int/iris/</a> |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Source of classification or shelving scheme |
NLM Classification Scheme |
Koha item type |
Books |