Clinical programs in the development of similar biotherapeutic products: Rationale and general principles-Reference-Cited by-同舟云学术

Clinical programs in the development of similar biotherapeutic products: Rationale and general principles

Published:2011-09 Issue:5 Volume:39 Page:293-296
ISSN:1045-1056
Container-title:Biologicals
language:en
Short-container-title:Biologicals

Author:

Berghout Alexander

Publisher

Elsevier BV

Subject

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

Reference24 articles.

1. CHMP/437/04 guideline on similar biological medicinal products,2005

2. EMEA/CHMP/49348/05 Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues,2006

3. EMEA/CHMP/42832/05 Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues,2006

4. EMEA/CHMP/32775/05 Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues – Guidance on similar medicinal products containing recombinant human insulin,2006

5. EMEA/CHMP/94528/05 Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues – Guidance on similar medicinal products containing somatropin,2006

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