‘Generic’ or ‘follow-on’ biologics: scientific considerations and safety issues-Reference-Cited by-同舟云学术

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‘Generic’ or ‘follow-on’ biologics: scientific considerations and safety issues

Published:2003-10 Issue:7 Volume:3 Page:1019-1022
ISSN:1471-2598
Container-title:Expert Opinion on Biological Therapy
language:en
Short-container-title:Expert Opinion on Biological Therapy

Author:

Green James D,Tsang Lincoln,Cavagnaro Joy A

Publisher

Informa Healthcare

Subject

Clinical Biochemistry,Drug Discovery,Pharmacology

Link

http://www.tandfonline.com/doi/pdf/10.1517/14712598.3.7.1019

Reference2 articles.

1. ICH Q6B: Guideline on specification: test procedures and accaeptance criteria for biotechnological/biological products. CPMP/365/96; 64 Fed. Reg. 444928, 18 August (1999).

2. ICH S6: Guideline on preclinical safety evaluation of biotechnology-derived pharmaceuticals.CPMP/32/95; 62 Fed. Reg. 61515, 18 November (1997).

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1. Biopharmaceuticals;Haschek and Rousseaux's Handbook of Toxicologic Pathology;2013

2. Clinical pharmacologic principles of the development and application of follow-on biological medicinal products;Orvosi Hetilap;2007-05-01

3. Correlation between Protein Binding Strength on Immobilized Metal Affinity Chromatography and the Histidine-Related Protein Surface Structure;Analytical Chemistry;2006-05-09

4. When biotech proteins go off-patent;Trends in Biotechnology;2004-08

5. Production of therapeutic proteins in fungal hosts;Expert Opinion on Biological Therapy;2004-05

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