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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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Détails bibliographiques
Auteurs principaux: Mahajan, Pooja, D’Souza, Natasha, Bhatt, Arun, Halbe, Vipul, Sharma, Richa, Narayanswamy, Shweta, Bughediwala, Murtuza
Format: Artigo
Langue:Inglês
Publié: Medknow Publications & Media Pvt Ltd 2012
Sujets:
Accès en ligne: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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