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Phases of Clinical Trials, Preclinical and Clinical Phase 1, Phase 2, Phase 3, and Phase 4 Studies.Vaccine, FDA, NIDA Clinical Trials.
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Gene therapy product development and clinical trials guidelines clearly outline the ethical and scientific requirements for gene therapy trials, keeping in mind patient safety, efficacy and clinical rigor as cornerstone of this initiative.

The aim of this document is to provide the basis of an enabling environment and guide scientifically sound practice that is ethical and beneficial to the Indian patient.

Download PDF Here

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