Evaluation of similar biotherapeutic products (SBPs): Scientific principles and their implementation-Reference-Cited by-同舟云学术

Evaluation of similar biotherapeutic products (SBPs): Scientific principles and their implementation

Published:2011-09 Issue:5 Volume:39 Page:256-261
ISSN:1045-1056
Container-title:Biologicals
language:en
Short-container-title:Biologicals

Author:

Knezevic Ivana

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference5 articles.

1. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs),2010

2. Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology,1991

3. Requirements for human interferons made by recombinant DNA techniques,1987

4. Requirements for human interferons prepared from lymphoblastoid cells, WHO TRS 786, Annex 3, adopted in 1988. http://webitpreview.who.int/entity/biologicals/biotechnology/WHO_TRS_786_A3.pdf

5. Guidelines for assuring the quality of monoclonal antibodies for use in humans, WHO,1991

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