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biotechnology (6) 6
animals (5) 5
humans (5) 5
quality control (5) 5
biological and medical sciences (3) 3
biological products - standards (3) 3
biology (3) 3
drug evaluation, preclinical (3) 3
european union (3) 3
fundamental and applied biological sciences. psychology (3) 3
legislation. general informations (3) 3
life sciences & biomedicine (3) 3
life sciences & biomedicine - other topics (3) 3
science & technology (3) 3
antibodies, monoclonal - biosynthesis (2) 2
antibodies, monoclonal - isolation & purification (2) 2
antibodies, monoclonal - standards (2) 2
biological products - isolation & purification (2) 2
drug industry (2) 2
reference standards (2) 2
viruses - isolation & purification (2) 2
antibodies, monoclonal - administration & dosage (1) 1
antibodies, monoclonal - toxicity (1) 1
biological factors - toxicity (1) 1
biological products - biosynthesis (1) 1
biological products - blood (1) 1
biological products - pharmacokinetics (1) 1
biological products - pharmacology (1) 1
biological products - toxicity (1) 1
biotechnology - standards (1) 1
blood coagulation factors - standards (1) 1
blood proteins - isolation & purification (1) 1
blood proteins - standards (1) 1
blood proteins - toxicity (1) 1
carcinogenicity tests (1) 1
cattle (1) 1
cell fusion (1) 1
cell line, transformed (1) 1
clone cells (1) 1
cloning, molecular (1) 1
cytokines (1) 1
cytokines - biosynthesis (1) 1
cytokines - isolation & purification (1) 1
cytokines - standards (1) 1
dna, recombinant (1) 1
dosage forms (1) 1
drug contamination (1) 1
drug-related side effects and adverse reactions (1) 1
encephalopathy, bovine spongiform - prevention & control (1) 1
encephalopathy, bovine spongiform - transmission (1) 1
gene expression (1) 1
genetic engineering (1) 1
genetic vectors (1) 1
hormones - toxicity (1) 1
hybridomas (1) 1
hybridomas - immunology (1) 1
hybridomas - microbiology (1) 1
immunoglobulins - blood (1) 1
immunoglobulins - isolation & purification (1) 1
mice (1) 1
mutagenicity tests (1) 1
pharmaceutical industry (1) 1
prion diseases - epidemiology (1) 1
prion diseases - prevention & control (1) 1
prion diseases - transmission (1) 1
protease inhibitors - blood (1) 1
protease inhibitors - standards (1) 1
reproduction - drug effects (1) 1
risk factors (1) 1
serum albumin - standards (1) 1
teratogens (1) 1
tumor cells, cultured (1) 1
vaccines - toxicity (1) 1
virology - methods (1) 1
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world health organization (1) 1
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1. Full Text Notes to applicants for marketing authorizations on the pre-clinical biological safety testing of medicinal products derived from biotechnology (and comparable products derived from chemical synthesis). Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety of Medicines
Journal of biological standardization, ISSN 0092-1157, 07/1989, Volume 17, Issue 3, pp. 203 - 212
Antibodies, Monoclonal - toxicity | Vaccines - toxicity | Biotechnology | Biological Products - pharmacokinetics | Blood Proteins - toxicity | Cytokines | Teratogens | Biological Products - pharmacology | Carcinogenicity Tests | Reproduction - drug effects | Animals | Drug-Related Side Effects and Adverse Reactions | Mutagenicity Tests | Biological Products - toxicity | Biological Factors - toxicity | Hormones - toxicity | Drug Evaluation, Preclinical | Index Medicus
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2. Full Text Notes to applicants for marketing authorizations on the production and quality control of medicinal products derived by recombinant DNA technology. Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy
Journal of biological standardization, ISSN 0092-1157, 07/1989, Volume 17, Issue 3, pp. 223 - 231
Gene Expression | Animals | Biotechnology - standards | Drug Industry | Cloning, Molecular | DNA, Recombinant | Biological Products - biosynthesis | Drug Evaluation, Preclinical | Genetic Vectors | Biological Products - standards | Quality Control | Index Medicus
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3. Full Text Note for guidance. Guidelines for medicinal products derived from human blood and plasma. Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines
Biologicals, ISSN 1045-1056, 06/1992, Volume 20, Issue 2, pp. 159 - 164
World Health Organization | Humans | Serum Albumin - standards | Biological Products - isolation & purification | Biological Products - standards | Immunoglobulins - isolation & purification | Blood Proteins - isolation & purification | Blood Proteins - standards | Immunoglobulins - blood | Blood Coagulation Factors - standards | Protease Inhibitors - blood | Protease Inhibitors - standards | Biological Products - blood | Quality Control | Index Medicus
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4. Full Text Note for guidance. Guidelines for minimizing the risk of transmitting agents causing spongiform encephalopathy via medicinal products. Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines
Biologicals, ISSN 1045-1056, 06/1992, Volume 20, Issue 2, pp. 155 - 158
Animals | Prion Diseases - transmission | Cattle | Humans | Risk Factors | Encephalopathy, Bovine Spongiform - transmission | Encephalopathy, Bovine Spongiform - prevention & control | Prion Diseases - epidemiology | Prion Diseases - prevention & control | Biological Products - standards | Index Medicus
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5. Full Text Note for guidance. Production and quality control of cytokine products derived by biotechnological processes. Committee for Proprietary Medicinal Products: Ad hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines
Biologicals, ISSN 1045-1056, 04/1991, Volume 19, Issue 2, pp. 125 - 131
Cytokines - standards | Biotechnology | Reference Standards | Cytokines - isolation & purification | Genetic Engineering | European Union | Cell Line, Transformed | Cytokines - biosynthesis | Quality Control | Index Medicus
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6. Full Text Notes to applicants for marketing authorizations on the production and quality control of monoclonal antibodies of murine origin intended for use in man. Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy
Journal of biological standardization, ISSN 0092-1157, 07/1989, Volume 17, Issue 3, pp. 213 - 222
Antibodies, Monoclonal - biosynthesis | Drug Industry | Humans | Antibodies, Monoclonal - standards | Antibodies, Monoclonal - isolation & purification | Cell Fusion | Reference Standards | Animals | Antibodies, Monoclonal - administration & dosage | European Union | Hybridomas | Clone Cells | Mice | Dosage Forms | Tumor Cells, Cultured | Drug Evaluation, Preclinical | Quality Control | Index Medicus
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7. Full Text Note for guidance. Production and quality control of human monoclonal antibodies. Committee for Proprietary Medicinal Products: Ad hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines
Biologicals, ISSN 1045-1056, 04/1991, Volume 19, Issue 2, pp. 133 - 138
Biotechnology | Viruses - isolation & purification | Viruses - genetics | European Union | Antibodies, Monoclonal - biosynthesis | Humans | Hybridomas - immunology | Antibodies, Monoclonal - standards | Antibodies, Monoclonal - isolation & purification | Hybridomas - microbiology | Quality Control | Index Medicus
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8. Full Text EEC regulatory document. Note for guidance. Validation of virus removal and inactivation procedures. Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines
Biologicals, ISSN 1045-1056, 07/1991, Volume 19, Issue 3, pp. 247 - 251
Viruses - isolation & purification | Animals | Virology - methods | Humans | Biological Products - isolation & purification | Drug Contamination | Index Medicus
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9. Full Text Notes to applicants for marketing authorizations on the pre-clinical biological safety testing of medicinal products derived from biotechnology (and comparable products derived from chemical synthesis)
by Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety of Medicines
Journal of biological standardization, ISSN 0092-1157, 1989, Volume 17, Issue 3, pp. 203 - 212
Biology | Life Sciences & Biomedicine - Other Topics | Life Sciences & Biomedicine | Science & Technology | Fundamental and applied biological sciences. Psychology | Biotechnology | Biological and medical sciences | Legislation. General informations
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10. Full Text Notes to applicants for marketing authorizations on the production and quality control of medicinal products derived by recombinant DNA technology
by Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy
Journal of biological standardization, ISSN 0092-1157, 1989, Volume 17, Issue 3, pp. 223 - 231
Biology | Life Sciences & Biomedicine - Other Topics | Life Sciences & Biomedicine | Science & Technology | Fundamental and applied biological sciences. Psychology | Biotechnology | Biological and medical sciences | Legislation. General informations
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11. INTERNATIONALE HARMONISIERUNGSKONFERENZ - ICH: EMPFEHLUNGEN ZU DOSIS-WIRKUNGS-STUDIEN VOM COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) VERABSCHIEDET
by Sickmuller, B and Gundert-Remy, U
Pharmazeutische Industrie, ISSN 0031-711X, 1994, Volume 56, Issue 10, pp. 853 - 856
Journal Article
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12. Full Text European Committee For Proprietary Medicinal Products Adopts Positive Opinion On Synagis For Prevention of RSV
PR newswire, 05/1999, p. 5242
Pharmaceutical industry
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13. Full Text Note for guidance: Production and quality control of cytokine products derived by biotechnological processes
by Committee for Proprietary Medicinal Products: Ad hoc Working Party on Biotechnology/Pharmacy and Committee for Proprietary Medicinal Products: Working Party on Safety Medicines
Biologicals, ISSN 1045-1056, 1991, Volume 19, Issue 2, pp. 125 - 131
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14. Full Text Note for guidance: Validation of virus removal and inactivation procedures
by Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Committee for Proprietary Medicinal Products: Working Party on Safety Medicines
Biologicals, ISSN 1045-1056, 1991, Volume 19, Issue 3, pp. 247 - 251
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15. Full Text Note for guidance: Production and quality control of human monoclonal antibodies
by Committee for Proprietary Medicinal Products: Ad hoc Working Party on Biotechnology/Pharmacy and Committee for Proprietary Medicinal Products: Working Party on Safety Medicines
Biologicals, ISSN 1045-1056, 1991, Volume 19, Issue 2, pp. 133 - 138
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16. Full Text Notes to applicants for marketing authorizations on the production and quality control of monoclonal antibodies of murine origin intended for use in man
by Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy
Journal of biological standardization, ISSN 0092-1157, 1989, Volume 17, Issue 3, pp. 213 - 222
Biology | Life Sciences & Biomedicine - Other Topics | Life Sciences & Biomedicine | Science & Technology | Fundamental and applied biological sciences. Psychology | Biotechnology | Biological and medical sciences | Legislation. General informations
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17. Full Text Note for guidance
by Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines
Biologicals, ISSN 1045-1056, 1992, Volume 20, Issue 2, pp. 159 - 164
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18. Full Text Note for guidance
by Committee for Proprietary Medicinal Products: Ad Hoc Working Party on Biotechnology/Pharmacy and Working Party on Safety Medicines
Biologicals, ISSN 1045-1056, 1992, Volume 20, Issue 2, pp. 155 - 158
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