Support for the revocation of general safety test regulations in biologics license applications-Reference-Cited by-同舟云学术

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Support for the revocation of general safety test regulations in biologics license applications

Published:2016-05 Issue:3 Volume:44 Page:178-181
ISSN:1045-1056
Container-title:Biologicals
language:en
Short-container-title:Biologicals

Author:

Evans Dana M.,Thorn Jennifer M.,Arch-Douglas Katherine,Sperry Justin B.,Thompson Bruce,Davis Heather L.,McCluskie Michael J.^ORCID

Publisher

Elsevier BV

Subject

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

Reference24 articles.

1. Revocation of general safety test regulations that are duplicative of requirements in biologics license applications. Final rule;Fed Regist,2015

2. Abnormal toxicity. 8.0, chapter 2.6.9;European Pharmacopeia,2013

3. WHO expert committee on biological standardization;World Health Organ Tech Rep Ser,1990

4. WHO expert committee on biological standardization;World Health Organ Tech Rep Ser,2014

5. WHO expert committee on biological standardization;World Health Organ Tech Rep Ser,2013

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