Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: Is 6 months still appropriate?-Reference-Cited by-同舟云学术

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Duration of chronic toxicity studies for biotechnology-derived pharmaceuticals: Is 6 months still appropriate?

Published:2008-02 Issue:1 Volume:50 Page:2-22
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Clarke Janet,Hurst Christopher,Martin Pauline,Vahle John,Ponce Rafael,Mounho Barbara,Heidel Shawn,Andrews Laura,Reynolds Theresa,Cavagnaro Joy

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference90 articles.

1. Abatacept, 2005a. Label http://www.fda.gov/cder/foi/label/2005/125118lbl.pdf.

2. Abatacept, 2005b. Summary Basis for Approval, Pharmacology Review(s) http://www.fda.gov/cder/foi/nda/2005/125118_s0000_OrenciaTOC.htm.

3. Adalimumab, 2002. Summary Basis for Approval http://www.fda.gov/cder/biologics/review/BLA125057_S000_HUMIRA_PHARMR.PDF.

4. Adalimumab, 2004. Summary Basis for Approval EPAR http://www.emea.europa.eu/humandocs/PDFs/EPAR/humira/400803en6.pdf.

5. Agalsidase, 2003. Label http://www.fda.gov/cder/foi/label/2003/agalgen042403LB.pdf.

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