BIOLOGICAL PRODUCT;
BLOOD CLOTTING FACTOR;
BLOOD DERIVATIVE;
ENOXAPARIN;
HUMAN ALBUMIN;
IMMUNOGLOBULIN;
RECOMBINANT ERYTHROPOIETIN;
RECOMBINANT HUMAN INSULIN;
STREPTOKINASE;
UROKINASE;
VACCINE;
BIOTECHNOLOGICAL PRODUCTION;
BIOTECHNOLOGY;
CENTRAL AMERICA;
DRUG APPROVAL;
DRUG INDUSTRY;
FOOD AND DRUG ADMINISTRATION;
GOVERNMENT REGULATION;
PRIORITY JOURNAL;
RECOMBINANT DNA TECHNOLOGY;
REVIEW;
SOUTH AND CENTRAL AMERICA;
BIOLOGICAL PRODUCTS;
BIOMEDICAL RESEARCH;
BIOTECHNOLOGY;
CARIBBEAN REGION;
DATA COLLECTION;
HEALTH POLICY;
HEALTH SERVICES RESEARCH;
HUMANS;
LATIN AMERICA;
PAN AMERICAN HEALTH ORGANIZATION;
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World Health Organization. Annex 1: good manufacturing practices for biological products. Geneva: WHO; 1992. Technical Report Series: 822.
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World Health Organization. Annex 2: guidelines for national authorities on quality assurance for biological products. Geneva: WHO; 1992. Technical Report Series: 822.
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Organización Panamericana de la Salud. Módulos I y II: Vacunas de Calidad, Washington: OPS; 2004.
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World Health Organization. Annex 3: guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology. Geneva: WHO; 1991. Technical Report Series: 814.
7
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World Health Organization. Annex 3: requirements for human interferons prepared from lymphoblastoid cells. Geneva: WHO; 1989. Technical Report Series: 786.
8
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World Health Organization. Annex 7: requirements for human interferons made by recombinant DNA techniques. Geneva: WHO; 1988. Technical Report Series: 771.
9
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World Health Organization. Annex 3: guidelines for assuring the quality of monoclonal antibodies for use in humans. Geneva: WHO; 1992. Technical Report Series: 822. Monoclonal antibodies.
10
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World Health Organization. WHO Informal Consultation on International Nonproprietary Names (INN) Policy for Biosimilar Products. Geneva; September 2006.
WHO International biological reference preparations held and distributed by the WHO International laboratories for biological standards cytokines/growth factors
World Health Organization. WHO International biological reference preparations held and distributed by the WHO International laboratories for biological standards cytokines/growth factors http://www.who.int/bloodproducts/catalogue/en/index.html; 2007.
(2007)
13
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European Medicines Agency. Guideline on similar biological medicinal products. CHMP/437/04; 2005.
14
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European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. EMEA/CHMP/BWP/49348/2005.
European Medicines Agency, EMEA/CHMP/BMWP/42832/2005
European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CHMP/BMWP/42832/2005.
European Medicines Agency, EMEA/CHMP/BMWP/496286/2006
European Medicines Agency. Concept paper on similar biological medicinal products containing low molecular weight heparins-non-clinical issues. EMEA/CHMP/BMWP/496286/2006.
Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues
European Medicines Agency, EMEA/CHMP/BMWP/31329/2005
European Medicines Agency. Annex to 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. EMEA/CHMP/BMWP/31329/2005.
European Medicines Agency, EMEA/CHMP/BMWP/32775/2005
European Medicines Agency. Annex to 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. EMEA/CHMP/BMWP/32775/2005.
European Medicines Agency, EMEA/CHMP/BMWP/94526/2005
European Medicines Agency. Annex to 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 erythropoietin. EMEA/CHMP/BMWP/94526/2005.
European Medicines Agency, EMEA/CHMP/BMWP/94528/2005
European Medicines Agency. Annex to 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. EMEA/CHMP/BMWP/94528/2005.
Guideline on comparability of biotechnology-derived therapeutic products after a change in the manufacturing process
European Medicines Agency, EMEA/CHMP/BMPW/101695/2006
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European Medicines Agency. Guidance on comparability of medicinal products containing biotechnology-derived proteins as active substance. Non-clinical and clinical issues. EMEA/CPMP/3097/02/2003.
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European Medicines Agency. Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance: quality issues. EMEA/CPMP/BWP/3207/00/2003.
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International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for human use. Comparability of biotechnological/biological products subject to changes in their manufacturing process Q5E; 2004
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International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for human use. Quality of biotechnological products: stability testing of biotechnological/biological products Q5C; 1995
International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for human use. Quality of biotechnological products: stability testing of biotechnological/biological products Q5C; 1995.
27
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International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for human use. Specifications: Test procedures and acceptance criteria for biotechnological/biological products Q6B; 1999
International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for human use. Specifications: Test procedures and acceptance criteria for biotechnological/biological products Q6B; 1999.
28
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International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for human use. Preclinical safety evaluation of biotechnology-derived pharmaceuticals S6; 1997
International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for human use. Preclinical safety evaluation of biotechnology-derived pharmaceuticals S6; 1997.
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Regulation of small-molecule drugs versus biologicals versus biotech products
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Cortés M., and Di Fabio J. Regulation of small-molecule drugs versus biologicals versus biotech products. In: Gad S.C. (Ed). Handbook of pharmaceutical biotechnology (2007) 1373-1390