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5 documents on 1 page
 
close this section of the librarybioequivalence studies
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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
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Regions: Global
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Title: Framework for Implementation of Equivalence Requirements for Pharmaceutical Products. PANDRH Technical Report Nº 8, Pan American Network on Drug Regulatory Harmonization
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 2011 Pages: 38
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Regions: Global; America (AMRO)
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Title: Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO Technical Report Series, No. 937, 2006, Annex 7
Subjects: Quality and Safety: Medicines > Quality Assurance
Quality and Safety: Medicines > Regulatory Support
Year: 2006 Pages: 44
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Regions: Global
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Title: Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3
Subjects: Quality and Safety: Medicines > Quality Assurance
Prequalification of Medicines > WHO-UNICEF-UN Project
Year: 2012 Pages: 29
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Regions: Global
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Title: 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
Subjects: Quality and Safety: Medicines > Quality Assurance
Year: 2006 Pages: 47
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Regions: Global
 

Last updated: May 3, 2013