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Title:
Description:
bioequivalent generic products
Title:
Disponibilidade no setor público e preços no setor privado: um perfil de medicamentos genéricos em diferentes regiões do Brasil (Availability of Generic Drugs in the Public Sector and Prices in the Private Sector in Different Regions of Brazil)
Author:
Campos, Mônica Rodrigues
;
Emmerick, Isabel Cristina Martins
;
Luiza, Vera Lucia
;
Miranda, Elaine Silva
;
Osorio-de-Castro, Claudia Garcia Serpa
;
Pinto, Cláudia Du Bocage Santos
;
Reis, André Luis de Almeida dos
Year:
2009
Pages:
12
Publishers:
PAHO/WHO Collaborating Center for Pharmaceutical Policies - National School of Public Health - Oswaldo Cruz Foundation
Countries:
Brazil
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
Publishers:
WHO Headquarters in Geneva
Related documents:
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
Regions:
Global
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
Publishers:
WHO Headquarters in Geneva
Related documents:
Additional Guidance for Organizations Performing in Vivo Bioequivalence Studies. WHO Technical Report Series, No. 937, 2006, Annex 9
Related links:
http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/index.html
Regions:
Global
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Last updated: May 3, 2013