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FDA approves Phase 0 trial which tests experimental drugs on humans

by Medindia Content Team on  January 13, 2006 at 7:39 PM Drug News   - G J E 4
FDA approves Phase 0 trial which tests experimental drugs on humans
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 understand the path of the drug in the body and its efficacy if the drug is proved effective in small quantities researchers can proceed with a phase I clinical trial.
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Researchers feel that easing the rules for drug testing will help in drug discovery and opens new options for better treatment. The FDA wants the researchers the ethical rules and informed consent has to be collected for undergoing these trials. This new trial method can also be called as '0 phase trial' as it is the trial involving small quantities of drugs which is in very minimum quantity to produce any adverse action on the health of the patients but, still all precautions with an organized follow up of the patient with the help of a physician should be done. The researchers feel that this phase 0 trial will help to actually evaluate the efficacy of the drug as most of the drugs which was found to be effective in experimental animals were ultimately found to have no therapeutic effect in humans during a clinical trial but this phase 0 trial would help in understanding more effectively the beneficial effect on humans.

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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.
Asra Tuesday, January 19, 2010
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..
Hiren B. Javiya Friday, November 28, 2008
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.
guest Thursday, August 21, 2008

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