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cerrar esta sección de la bibliotecaPrequalification of Medicines
cerrar esta sección de la bibliotecaWHO-UNICEF-UN Project
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Título: Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2006 Páginas: 23
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Regiones: Global
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Título: Ensuring Quality Medicines: A Decade of Prequalification
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Autore: van Zyl, A. J.
Año: 2011 Páginas: 9
Publicadores:
Regiones: Global
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Título: Guidance on Variations to a Prequalified Product Dossier. WHO Technical Report Series, No. 943, 2007 Annex 6
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2007 Páginas: 50
Publicadores:
Regiones: Global
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Título: Guidelines for Registration of Fixed-dose Combination Medicinal Products. WHO Technical Report Series, No. 929, 2005, Annex 5
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2005 Páginas: 49
Publicadores:
Regiones: Global
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Título: Guidelines for the Compilation of a Product Dossier for Submission in the Assessment Procedure for New and Multi-Source (Generic) Products Used in the Treatment of Malaria
Temas: Prequalification of Medicines > WHO-UNICEF-UN Project
Páginas: 11
Publicadores:
Regiones: Global
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Título: Guidelines for the Preparation of a Procurement Agency Information File. WHO Technical Report Series, No. 917, 2003, Annex 7
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2003 Páginas: 4
Publicadores:
Regiones: Global
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Título: Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2008 Páginas: 10
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Regiones: Global
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Título: Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2012 Páginas: 76
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Regiones: Global
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Título: Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 12
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Regiones: Global
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Título: Guidelines on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 961, 2011, Annex 11
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 2
Publicadores:
Documentos relacionados:
Regiones: Global
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Título: Guidelines on the Requalification of Prequalified Dossiers. WHO Technical Report Series, No. 957, 2010, Annex 6
Temas: Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2010 Páginas: 6
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Regiones: Global
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Título: Handbook: Good Laboratory Practice (GLP). Quality Practices for Regulated Non-clinical Research and Development - 2nd Ed.
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2009 Páginas: 328
Publicadores:
Documentos relacionados:
Regiones: Global
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Título: Improving Quality for Better Treatment and Greater Access
Temas: Medicine Access and Rational Use > Pricing
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2012 Páginas: 7
Publicadores:
Regiones: Global
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Título: Inspection of API Manufacturing Sites
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 4
Publicadores:
Regiones: Global
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Título: Mechanism to Combat Substandard/Spurious/Falsely-labelled/ Falsified/Counterfeit Medical Products (WHO Drug Information, Vol 27, No. 1, 2013)
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > Counterfeit Medicines
Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2013 Páginas: 2
Publicadores:
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Regiones: Global; África (AFRO)
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Título: A Model Quality Assurance System for Procurement Agencies - Recommendations for Quality Assurance Systems Focusing on Prequalification of Products and Manufacturers, Purchasing, Storage and Distribution of Pharmaceutical Products [French]
Temas: Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2007 Páginas: 140
Publicadores:
Regiones: Global
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Título: Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2012 Páginas: 29
Publicadores:
Documentos relacionados:
Regiones: Global
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Título: Prequalification of Diagnostics Update, Issue 1, Q1 2008 - Diagnostics and Laboratory Technology
Temas: Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2008 Páginas: 2
Publicadores:
Regiones: Global
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Título: Prequalification of Diagnostics Update, Issue 2, Q2 2008 - Diagnostics and Laboratory Technology
Temas: Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2008 Páginas: 2
Publicadores:
Regiones: Global
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Título: Prequalification of Diagnostics Update, Issue 3, Q3 2009 - Diagnostics and Laboratory Technology
Temas: Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2009 Páginas: 2
Publicadores:
Regiones: Global
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Título: Prequalification of Diagnostics Update, Issue 4, Q3 2010 - Diagnostics and Laboratory Technology
Temas: Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2010 Páginas: 2
Publicadores:
Regiones: Global
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Título: Prequalification of Diagnostics Update, Issue 5, Q4 2010 - Diagnostics and Laboratory Technology
Temas: Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2010 Páginas: 2
Publicadores:
Regiones: Global
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Título: Prequalification of Diagnostics Update, Issue 6, Q1 2011 - Diagnostics and Laboratory Technology
Temas: Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 2
Publicadores:
Regiones: Global
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Título: Prequalification of Quality Control Laboratories. Procedure for Assessing the Acceptability, in Principle, of Quality Control Laboratories for Use by United Nations Agencies. WHO Technical Report Series, No. 961, 2011, Annex 12 [French]
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 10
Publicadores:
Regiones: Global
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Título: Procedure for Prequalification of Pharmaceutical Products. WHO Technical Report Series, No. 961, 2011 Annex 10
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 17
Publicadores:
Documentos relacionados:
Regiones: Global
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Título: Programme Activities in 2005: WHO Prequalification Programme [French]
Temas: Medicine Information and Evidence for Policy > Information and Publications
Medicine Information and Evidence for Policy > Medicines Policy
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2005 Páginas: 10
Publicadores:
Regiones: Global
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Título: A Rapid Quality Risk Assessment Mechanism for Assessing Needed Pharmaceutical Products that Have Not Completed a Stringent Assessment. WHO Prequalification of Medicines Programme - Briefing Paper: 27 April 2012. Expert Review Panel (ERP)
Temas: Medicine Access and Rational Use > Supply Management
Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2012 Páginas: 13
Publicadores:
Regiones: Global
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Título: Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. WHO Technical Report Series, No. 953, 2009 - Annex 2. (With Table 2 - Updated 1 December 2010)
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2009 Páginas: 50
Publicadores:
Regiones: Global
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Título: Supplementary Guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-conditioning Systems for Non-sterile Pharmaceutical Dosage Forms. WHO Technical Report Series, No. 961, 2011, Annex 5
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 46
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 23, No. 3, 2009 - Recommended INN List 62 - International Nonproprietary Names for Pharmaceutical Substances
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2009 Páginas: 78
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 23, No. 4, 2009 - Proposed International Nonproprietary Names, List 102
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > Blood Products and Related Biologicals
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2009 Páginas: 97
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 24, No. 1, 2010 - Recommended International Nonproprietary Names, List 63
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2010 Páginas: 80
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 24, No. 2, 2010 - Proposed International Nonproprietary Names, List 103
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2010 Páginas: 118
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 24, No. 3, 2010 - Recommended International Nonproprietary Names, List 64
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2010 Páginas: 92
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 24, No. 4, 2010 - Proposed International Nonproprietary Names, List 104
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2010 Páginas: 128
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 25, No. 1, 2011 - Recommended International Nonproprietary Names, List 65
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 98
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 25, No. 2, 2011 - Proposed International Nonproprietary Names, List 105
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 120
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 25, No. 4, 2011 - Proposed International Nonproprietary Names, List 106
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 125
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 26, No. 1, 2012 - Recommended International Nonproprietary Names, List 67
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2012 Páginas: 96
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 26, No. 2, 2012 - Proposed International Nonproprietary Names, List 107
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2012 Páginas: 139
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 26, No. 3, 2012 - Recommended International Nonproprietary Names, List 68
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2012 Páginas: 100
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 26, No. 4, 2012 - Proposed International Nonproprietary Names, List 108
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2013 Páginas: 135
Publicadores:
Regiones: Global
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Título: WHO Drug Information Vol. 27, No. 1, 2013 - Recommended International Nonproprietary Names, List 69
Temas: Medicine Information and Evidence for Policy > Information and Publications
Quality and Safety: Medicines > Blood Products and Related Biologicals
Quality and Safety: Medicines > Counterfeit Medicines
Quality and Safety: Medicines > International Nonproprietary Names
Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > Safety and Efficacy
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2013 Páginas: 93
Publicadores:
Regiones: Global
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Título: WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 957 - Forty-fourth Report
Temas: Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2010 Páginas: 292
Publicadores:
Documentos relacionados:
Regiones: Global
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Título: WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 961 - Forty-fifth Report (Geneva, 18–22 October 2010)
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 440
Publicadores:
Regiones: Global
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Título: WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 970 - Forty-sixth Report (Geneva, 10–14 October 2011)
Temas: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Quality and Safety: Medicines > The International Pharmacopoeia
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2012 Páginas: 250
Publicadores:
Documentos relacionados:
Regiones: Global
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Título: WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles. WHO Technical Report Series, No. 961, 2011, Annex 3
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 54
Publicadores:
Regiones: Global
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Título: WHO Good Manufacturing Practices for Sterile Pharmaceutical Products. WHO Technical Report Series, No. 961, 2011, Annex 6
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 24
Publicadores:
Regiones: Global
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Título: WHO Good Manufacturing Practices: Water for Pharmaceutical Use. WHO Technical Report Series, No. 970, 2012, Annex 2
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2012 Páginas: 23
Publicadores:
Documentos relacionados:
Enlaces relacionados:
Regiones: Global
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Título: WHO Good Practices for Pharmaceutical Microbiology Laboratories. WHO Technical Report Series, No. 961, 2011, Annex 2
Temas: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Año: 2011 Páginas: 25
Publicadores:
Regiones: Global
 
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Última actualización: le 3 mayo 2013