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Clinical Trials - Different Phases of the trial - Pre-Clinical Testing
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Clinical Trials - Different Phases of the trial
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Clinical Trials - Different Phases of the trial
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Pre-Clinical Testing |
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After the drug is found beneficial on animal models the sponsor of the new molecule/ drug files the IND (Investigational New Drug) application. In this application, the pharmaceutical company should describe its plan of action for the next phase of the trial to be carried out in humans, including details such as, how many participants the study will involve; what criteria will be used for enrolling participants; where the studies will take place; and, how drug safety and efficacy will be measured. If the above details is accepted by the Licensing Authority (Drug Controller of India - DCGI ) or FDA , drug testing in human subjects can begin within 30 days. |
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