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Title:
Description:
Good Clinical Practice (GCP)
Title:
Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Prequalification of Medicines
>
WHO-UNICEF-UN Project
Year:
2006
Pages:
23
Publishers:
WHO Headquarters in Geneva
Related documents:
WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report
Proposal to Waive in Vivo Bioequivalence Requirements for WHO Model List of Essential Medicines Immediate-release, Solid Oral Dosage Forms. WHO Technical Report Series, No. 937, 2006, Annex 8
Regions:
Global
Title:
Buenas Prácticas Clínicas: Documento de las Américas
Subjects:
Calidad y seguridad de los medicamentos
>
Apoyo en materia de reglamentación
Calidad y seguridad de los medicamentos
>
Seguridad y eficacia
Year:
2005
Pages:
101
Publishers:
World Health Organization - Regional Office for the Americas (WHO/AMRO/PAHO)
Regions:
America (AMRO)
Title:
Clinical Pharmacology in Health Care, Teaching and Research
Subjects:
Medicine Access and Rational Use
>
Rational Use
Quality and Safety: Medicines
>
Safety and Efficacy
Year:
2012
Pages:
80
Publishers:
WHO Headquarters in Geneva
Council for International Organizations of Medical Sciences (CIOMS)
International Union of Basic and Clinical Pharmacology (IUPHAR)
Regions:
Global
Title:
Comité OMS d'experts sur la sélection et l'utilisation des médicaments essentiels - OMS, série de rapports techniques, No. 850, Annexe 3 (Lignes directrices relatives aux Bonnes Pratiques Cliniques (BPC) pour l'essai des médicaments) - Sixième rapport
[
English
] [
Spanish
]
Subjects:
Qualité et innocuité des médicaments
>
Assurance de la qualité
Qualité et innocuité des médicaments
>
Innocuité et efficacité
Year:
1995
Pages:
44
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans. WHO Technical Report, Series No. 863 , 1996, Annex 7
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Year:
1996
Pages:
16
Publishers:
WHO Headquarters in Geneva
Related links:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Regions:
Global
Title:
Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation
Subjects:
Quality and Safety: Medicines
>
Safety and Efficacy
Year:
2005
Pages:
132
Publishers:
WHO Headquarters in Geneva
Title:
Paediatric Clinical Trials Guidance for Assessors
Subjects:
Medicine Access and Rational Use
>
Better Medicines for Children
Quality and Safety: Medicines
>
Safety and Efficacy
Year:
2011
Pages:
41
Publishers:
WHO Headquarters in Geneva
Regions:
Global
Title:
WHO Expert Committee on Selection and Use of Essential Medicines - WHO Technical Report Series, No. 850, Annex 3 (Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products) - Sixth Report
[
French
] [
Spanish
]
Subjects:
Quality and Safety: Medicines
>
Quality Assurance
Quality and Safety: Medicines
>
Safety and Efficacy
Year:
1995
Pages:
36
Publishers:
WHO Headquarters in Geneva
Regions:
Global
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Last updated: May 3, 2013