Review of quality deficiencies found in active pharmaceutical ingredient master files submitted to the WHO Prequalification of Medicines Programme
IO Diego, A Fake, M Stahl… - Journal of Pharmacy & …, 2014 - journals.library.ualberta.ca
Purpose. The aim of this work was to determine the number and type of active
pharmaceutical ingredient (API) quality deficiencies in API Master Files (APIMFs) as …
pharmaceutical ingredient (API) quality deficiencies in API Master Files (APIMFs) as …
Deficiencies in generic product dossiers as submitted to the WHO Prequalification of Medicines Programme
WZ Worku, J Gordon, MMS Stahl… - Journal of Generic …, 2012 - journals.sagepub.com
This study was undertaken to determine the type and extent of deficiencies in generic
product dossiers in the therapeutic areas of HIV/AIDS, tuberculosis, malaria and …
product dossiers in the therapeutic areas of HIV/AIDS, tuberculosis, malaria and …
Common deficiencies found in the active pharmaceutical ingredient (API) section of non-sterile generic products submitted for registration by SAHPRA
L Moeti, M Litedu, J Joubert - Therapeutic Innovation & Regulatory …, 2022 - Springer
Purpose This research study aims to determine the qualitative and quantitative common
deficiencies included in the API section of dossiers submitted to SAHPRA. The study was …
deficiencies included in the API section of dossiers submitted to SAHPRA. The study was …
Statistics, quality review issues, and beyond for generic drug applications in Taiwan
LC Chang, CS Gau - Therapeutic Innovation & Regulatory …, 2013 - journals.sagepub.com
The aim of the present study was to investigate the characteristics and deficiencies listed in
the final quality assessment reports of generic drug applications submitted in Taiwan. The …
the final quality assessment reports of generic drug applications submitted in Taiwan. The …
Advantages of using an abbreviated dossier for drug master file applications in Taiwan
IC Sun - Regulatory Toxicology and Pharmacology, 2016 - Elsevier
In Taiwan, the quality of active pharmaceutical ingredients is recorded in a drug master file
(DMF), the applications for which can be submitted in two dossier types, either full (complete …
(DMF), the applications for which can be submitted in two dossier types, either full (complete …
Regulatory status of drug master file in Taiwan 2009–2011
IC Sun, FC Lu, KJ Lu, TY Liao… - Journal of Generic …, 2014 - journals.sagepub.com
The drug master file submission in Taiwan commenced on 1 October 2009 and is driven by
the health reimbursed pricing system. To clarify the consequences of this policy, we focused …
the health reimbursed pricing system. To clarify the consequences of this policy, we focused …
Análisis retrospectivo de las deficiencias de calidad encontradas en los master files de ingredientes activos farmacéuticos para la precalificación de medicamentos …
I Ortega Diego - 2017 - docta.ucm.es
Análisis retrospectivo de las deficiencias de calidad encontradas en los master files de
ingredientes activos farmacéuticos pa Page 1 UNIVERSIDAD COMPLUTENSE DE …
ingredientes activos farmacéuticos pa Page 1 UNIVERSIDAD COMPLUTENSE DE …
[PDF][PDF] Patentes e inovação: o sistema de patentes promove a inovação?
AIGS Neves - 2008 - repositorio.ul.pt
Ultrapassado o modelo clássico de economia, no qual ajustamentos no lado dos
consumidores ou dos produtores chegariam para corrigir a equação da oferta e da procura …
consumidores ou dos produtores chegariam para corrigir a equação da oferta e da procura …
Patentes e inovação: O sistema de patentes promove a inovação?
AIG da Silva Neves - 2008 - search.proquest.com
Ultrapassado o modelo clássico de economia, no qual ajustamentos no lado dos
consumidores ou dos produtores chegariam para corrigir a equação da oferta e da procura …
consumidores ou dos produtores chegariam para corrigir a equação da oferta e da procura …