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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...

詳細記述

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書誌詳細
主要な著者: Mahajan, Pooja, D’Souza, Natasha, Bhatt, Arun, Halbe, Vipul, Sharma, Richa, Narayanswamy, Shweta, Bughediwala, Murtuza
フォーマット: Artigo
言語:Inglês
出版事項: Medknow Publications & Media Pvt Ltd 2012
主題:
オンライン・アクセス: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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