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1
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78651290572
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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
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EMEA/CHMP/94528/05 CHMP adopted February
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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. Committee for Medical Products for Human Use. EMEA/CHMP/94528/05 (CHMP adopted February 2006).
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(2006)
Committee for Medical Products for Human Use
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2
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78651283409
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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 erythropoietins
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EMEA/CHMP/BMWP/94526/2005 CHMP adopted March
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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 Erythropoietins. Committee for Medica l Products for Human Use. EMEA/CHMP/BMWP/94526/2005 (CHMP adopted March 2006).
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(2006)
Committee for Medica L Products for Human Use
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3
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78651345536
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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 granulocyte-colony stimulating factor
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EMEA/CHMP/BMWP/31329/2005 CHMP adopted February
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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 Granulocyte-Colony Stimulating Factor. Committee for Medical Products for Human Use. EMEA/CHMP/BMWP/31329/2005 (CHMP adopted February 2006).
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(2006)
Committee for Medical Products for Human Use
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4
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78651270742
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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 soluble insulin
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EMEA/CHMP/BMWP/32775/2005 CHMP adopted February
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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 Soluble Insulin. Committee for Medical Products for Human Use. EMEA/CHMP/BMWP/32775/2005 (CHMP adopted February 2006).
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(2006)
Committee for Medical Products for Human Use
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6
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84905339418
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Company website
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Company website. http://www.drreddys.com/products/popups/reditux.htm
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9
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78651264955
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Guideline on similar biological medicinal products
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CHMP/437/04 CHMP adopted September
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Guideline on Similar Biological Medicinal Products. Committee for Medical Products for Human Use. CHMP/437/04 (CHMP adopted September, 2005).
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(2005)
Committee for Medical Products for Human Use
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10
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78651271157
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Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues
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EMEA/CHMP/BWP/49348/05 CH MP adopted February
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Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues. Committee for Medical Products for Human Use. EMEA/CHMP/BWP/49348/05 (CH MP adopted February, 2006).
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(2006)
Committee for Medical Products for Human Use
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11
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77956715996
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Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues
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EMEA/CHMP/42832/05 CHMP adopted February
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Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. Committee for Medical Products for Human Use. EMEA/CHMP/42832/05 (CHMP adopted February, 2006).
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(2006)
Committee for Medical Products for Human Use
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12
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78651343997
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Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins
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EMEA/CHMP/BMWP/14327/2006 CHMP adopted December
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Guideline on Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins. Committee for Medical Products for Human Use. EMEA/CHMP/BMWP/14327/2006 (CHMP adopted December, 2007).
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(2007)
Committee for Medical Products for Human Use
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15
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84889330036
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Considerations for biotechnology product quality by design
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A. S. Rathore and R. Mhatre, Eds. Wiley Interscience, New York
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S. Kozlowski and P. Swann, "Considerations for biotechnology product Quality by design", in Quality by Design for Biopharmaceuticals, A. S. Rathore and R. Mhatre, Eds. (Wiley Interscience, New York, 2009), pp. 9-30.
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(2009)
Quality by Design for Biopharmaceuticals
, pp. 9-30
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Kozlowski, S.1
Swann, P.2
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18
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84905361836
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Office of Science and Technology Policy, Coordinated Framework for Regulation of Biotechnology, 26 June
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Office of Science and Technology Policy, Coordinated Framework for Regulation of Biotechnology, United States Regulatory Agencies Unified Biotechnology website [online], http://usbiotechreg.nbii.gov/Coordinated- Framework-1986-Federal-Register.html> (26 June, 1986).
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(1986)
United States Regulatory Agencies Unified Biotechnology Website [Online]
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24
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0031841745
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R. A. Rudick et al., Neurology 50, 1266-1272, (1998).
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(1998)
Neurology
, vol.50
, pp. 1266-1272
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Rudick, R.A.1
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26
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45149095388
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Applications of failure modes and effects analysis to biotechnology manufacturing processes
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A. S. Rathore and G. Sofer, Eds. Taylor & Francis, Boca Raton, Florida
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R. J. Seely and J. Haury, Applications of failure modes and effects analysis to biotechnology manufacturing processes, in Process Validation in Manufacturing of Biopharmaceuticals, A. S. Rathore and G. Sofer, Eds. (Taylor & Francis, Boca Raton, Florida, 2005), pp. 13-30.
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(2005)
Process Validation in Manufacturing of Biopharmaceuticals
, pp. 13-30
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Seely, R.J.1
Haury, J.2
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31
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84889418037
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Case study on definition of design space for a microbial fermentation step
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A. S. Rathore and R. Mhatre, Eds. Wiley Interscience, Hoboken, New Jersey
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P. van Hoek, J. Harms, X. Wang, and A. S. Rathore, Case Study on Definition of Design Space for a Microbial Fermentation Step, in Quality by Design for Biopharmaceuticals: Perspectives and Case Studies, A. S. Rathore and R. Mhatre, Eds. (Wiley Interscience, Hoboken, New Jersey, 2009) 85-109.
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(2009)
Quality by Design for Biopharmaceuticals: Perspectives and Case Studies
, pp. 85-109
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Van Hoek, P.1
Harms, J.2
Wang, X.3
Rathore, A.S.4
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