WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19–20 April 2007

Author:

Joung Jeewon,Robertson James S.,Griffiths Elwyn,Knezevic Ivana

Publisher

Elsevier BV

Subject

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

Reference17 articles.

1. Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology. In: WHO Expert Committee on Biological Standardization. Forty-first report. Geneva, World Health Organization, 1991, Annex 3 (WHO Technical Report Series No. 814).

2. Requirements for the use of animal cells as in vitro substrates for the production of biologicals. In: WHO Expert Committee on Biological Standardization. Forty-seventh report. Geneva, World Health Organization, 1998, Annex 1 (WHO technical report series no. 878).

3. WHO reference materials for cytokines/growth factors and endocrinological substances (available on the internet at http://www.who.int/bloodproducts/Catalogue/en/index.html).

4. 12th international conference of drug regulatory authorities recommendation (available on the internet at http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/recc_final.pdf).

5. WHO Expert Committee on Biological Standardization. Fifty-sixth report. Geneva, World Health Organization (WHO technical report series no. 941), in press.

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