WHO Expert Committee on Biological Standardization : fifty-sixth report.

Format:

Book

Author/Creator:

WHO Expert Committee on Biological Standardization. Meeting (56th : 2005 : Geneva, Switzerland)

Contributor:

World Health Organization.

Series:

Technical report series (World Health Organization) ; 941.

WHO technical report series, 0512-3054 ; 941

Language:

English

Subjects (All):

Biological products--Standards--Congresses.

Biological products.

Drugs--Standards--Congresses.

Drugs.

Physical Description:

1 online resource (352 pages)

Edition:

1st ed.

Place of Publication:

Geneva : World Health Organization, 2007.

Language Note:

English

Summary:

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations to assure the quality safety and efficacy of vaccines blood products and other biological medicines and the establishment of international biological reference standards for these products and related diagnostic devices. The report of particular relevance to manufacturers and national regulatory authorities starts with a discussion of general issues brought to the Committee's attention. The second part of the report contains written

Contents:

Technical Report Series: WHO Expert Committee on Biological Standardization, 56th report; Contents; Introduction; General; International guidelines, recommendations and other matters related to the manufacture and quality control of biologicals; International reference materials; Antigens and related substances; Antisera; Blood products and related substances; Cytokines, growth factors and endocrinological substances; Diagnostic reagents; Annex 1: Guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines

Annex 2: Recommendations for inactivated rabies vaccine for human use produced in cell substrates and embryonated eggs Annex 3: Guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines (oral); Annex 4: Recommendations for the production, control and regulation of human plasma; Annex 5: WHO biosafety risk assessment and guidelines for the production and quality control of human influenza pandemic vaccines; Annex 6: Recommendations for whole-cell pertussis vaccine; Annex 7: Biological substances - international standards and reference reagents; Annex 8: Recommendations, guidelines and other documents for biological substances used in medicine

Notes:

Description based upon print version of record.

Includes bibliographical references.

ISBN:

92-4-068619-3

OCLC:

714569825