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Tag: Ethics Committee.

By - admin

Clinical Trial vs Biomedical Research: Do we need a sorting hat?

Clinical Trial vs Biomedical Research: Do we need a sorting hat? New Drugs and Clinical Trial approval regulations 2019 have made a distinction between clinical research and biomedical research and the ethics Committees (EC) to approve the same. To approve clinical research, we need to approach an E...

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By - admin

Regulatory provisions not applicable …. Explain please

Doctors often have a misconception that a Phase IV study is a Post Marketing Surveillance (PMS)study. I remember having discussions with friends to clarify that if a phase III protocol is repeated after marketing a product, it does not become a PMS. They are different types of studies both conducted...

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