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US food and drug administration Indian site inspections: An experience

Since 2005, USFDA has begun inspections of Indian clinical trial investigator sites. This paper reports experience of an FDA inspection performed at two Indian centers. The inspection started with an in-depth discussion with the investigator and his team about the conduct of the clinical trial at th...

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Detalhes bibliográficos
Main Authors: Mahajan, Pooja, D’Souza, Natasha, Bhatt, Arun, Halbe, Vipul, Sharma, Richa, Narayanswamy, Shweta, Bughediwala, Murtuza
Formato: Artigo
Idioma:Inglês
Publicado em: Medknow Publications & Media Pvt Ltd 2012
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3371552/
https://ncbi.nlm.nih.gov/pubmed/22701824
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.4103/2229-3485.96453
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