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FDA approves Phase 0 trial which tests experimental drugs on humans
medindia 8870 Posts Good news for researchers has FDA has approved testing of small quantities of experimental drugs in human beings. Approval of small quantity drug clinical trial will be very helpful for researchers to...Read More
Posted on : Friday, January 13, 2006 12:00 AM

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Its good news. It will save so much time and money for the sponsor. but more information about this is required. Please mention which guideline specifies the FDA requirements for phase 0 trials. Thanks.

Replied on Thursday, August 21, 2008 12:00 AM

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Hiren B. Javiya

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I am very happy, when i read this NEWS; because it very imp. for pharma and C.R. industry to save their there time, path of the drug and specially efficacy, which is prime requirement for the clinical trial. I really grateful to all the members of FDA. thank you so much..

Replied on Friday, November 28, 2008 12:00 AM

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Asra

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Yup, this is very good idea of microdosing. Adverse effect will not be much and efficacy of it will be known faster.

Replied on Tuesday, January 19, 2010 12:00 AM

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