Clinical Review And FDA Approval For Drug Discovery

Before a drug can be tested in people, the drug company or sponsor implements laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit.

  • Analysis of the target condition and available treatments
  • Assessment of benefits and risks from clinical data
  • Strategies for managing risks

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