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Guidelines on Evaluation of Similar - World Health Organization
WHO Expert Committee on Biological Standardization Sixtieth report .... Recommendations and regulatory guidance are available elsewhere (http://www. who.int/biologicals/areas/en/), are excluded from the scope of this document. 4. Glossary.
TRS_977_Annex_2.pdf

Guidelines on evaluation of similar biotherapeutic products (SBPs
Jun 12, 2009 ... ... be posted on WHO Biologicals website (http://www.who.int/biologicals/en/) for ... Publications of the World Health Organization can be obtained from WHO ... city or area or of its authorities, or concerning the delimitation of its ...
Guidelines_Biotherapeutic_products_FINAL_HK_IK_12_June.pdf

Good manufacturing practices for biological products pdf, 2.80Mb
WHO Expert Committee on Biological Standardization. Forty-second Report. Geneva, World Health Organization, 1992 (WHO Technical Report Series,. No. 822) ...
WHO_TRS_822_A1.pdf?ua=1

Annex 1 - World Health Organization
peptide vaccines, the guidelines cover the following main areas: .° control of ... quality control of biological products, such as tests for potency, pyro- genicity ...
WHO_TRS_889_A1.pdf

Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page
thoroughly characterized. Requirements published by WHO are intended to be scientific and advisory in nature. The parts of each section printed in normal type.
WHO_TRS_878_A1Animalcells.pdf

Page 1 Page 2 Two controlled, double-blind, randomized field trials
against typhoid fever in areas with high endemicity. .... for Biological Substances No.23 (Requirements for Meningococcal. Polysaccharide Vaccine) (15, 16).
WHO_TRS_840_A1.pdf

Annex 1 Recommendations for the production and control of
subsequently adopted (2) that introduced changes in four areas: (1) to meet the .... The Biologicals unit of WHO initiated a series of international col- laborative ...
WHO_TRS_904_A1polio_oral.pdf

guidelines on stability evaluation of vaccines - World Health
Publications of the World Health Organization can be obtained from WHO ... whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or .... authorities and for vaccine manufacturers (www.who.int/biologicals). ..... (http://www.who.int/biologicals/IBRP /index.htm).
Microsoft Word - BS 2049.Stability.final.09_Nov_06.pdf

Annex 2 Guidelines for the production and control of the acellular
The immunological, biological and biochemical characterization of the individual .... The guidelines cover control of the following three areas: ' the starting ...
WHO_TRS_878_A2.pdf

Recommendations to assure the quality, safety and efficacy of group
Publications of the World Health Organization can be obtained from WHO Press, World Health ... 791 4806; e-mail: [email protected]). ... territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines ... vaccines were adopted by the WHO Expert Committee on Biological ...
MenAFinalBS204102.Nov.06.pdf

WHO Guidelines on regulatory issues related to the elimination
www.who.int/biologicals. The focus was on vaccines already licensed with thiomersal when used as an inactivating agent and/ or as a preservative.
whothimerosal.pdf

Self procurement FAQ - Gavi
http://www.who.int/biologicals/publications/trs/areas/vaccines/en/index.html ... ( e.g. pharmaceuticals and biological products, such as vaccines) meet national ...
self-procurement-faq

Behind Vaccine Development - Takeda
Retrieved from http://www.who.int/biologicals/publications/trs/areas/vac cines/ clinical_evaluation/035-101.pdf?ua=1. 2 National Institutes of Health (2016).
Behind_Vaccine_Development_The_Clinical_Trial_Process.pdf

vaccines. For plant - Rivm Repository
Jan 25, 2006 ... (http://www.who.int/biologicals/publications/trs/areas/vaccines/ nonclinical_evaluation/ANNEX 1N onclinical.P31-63.pdf, accessed 24 Jan ...
laan.pdf

Animal Refinement and Reduction: Alternative Approaches for
Dec 23, 2011 ... Available at: http://www.who.int/biologicals/publications/trs/areas/vaccines/dtp/en/ index.html [7] Assay of diphtheria vaccine (adsorbed).
1-s2.0-S1877282X11000385-main.pdf?_tid=2d06f22a-c523-11e3-bedc-00000aacb361&acdnat=1397624242_3a017e53672563c9b5208bf1c88decb0

WHO Information on Mercury - UNEP
WHO (http://whqlibdoc.who.int/publications/2005/9241592648.pdf) .... (http://www .who.int/entity/biologicals/publications/trs/areas/vaccines/thiomersal/Annex% ...
WHO Information on Mercury.pdf

Strengthening National Regulatory Authorities for - PAHO/WHO
Aug 31, 2010 ... Analysis. 8. Some national regulatory authorities in the Region of the Americas have .... http://www.who.int/biologicals/publications/trs/areas/ ...
CD50-20-e.pdf

“Towards global harmonisation of 3Rs in biologicals” - CIRCABC
Sep 16, 2015 ... specific animal tests for the QC of vaccines and other biologicals ...... http://www. who.int/biologicals/publications/trs/areas/vaccines/gmp/en/.
ihb sept 2015 report.pdf

Full-Text PDF - MDPI.com
Feb 2, 2010 ... Division of Virology, National Institute for Biological Standards and Control, ...... http://www.who.int/biologicals/publications/trs/areas/vaccines/ ...
c5e8bdcdf591c95d99fff835a4d087829318.pdf

A Dose-Escalation Safety and Immunogenicity Study of Live
Jun 22, 2009 ... survey conducted in urban middle to low class neighborhoods in New Delhi. ...... Available at: http://www.who.int/biologicals/publications/trs/.
421.full.pdf

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