Question

7. Describe the clinical development process that a drug undergoes.

Answer 1

The clinical development process of a drug involves Phase I, II, and III clinical trials to assess its safety and efficacy. After successful completion of the trials, a New Drug Application is submitted, and the drug undergoes FDA approval.

Step-by-step explanation:

The clinical development process of a drug involves several stages:

1. Phase I Clinical Trials: This is the first stage where the drug is administered to humans to determine its safety and tolerability. Pharmacokinetic properties are also evaluated during this phase.
2. Phase II Clinical Trials: In this stage, the drug is tested on a larger group of patients to assess its effectiveness in treating the targeted condition.
3. Phase III Clinical Trials: This phase involves a larger patient population and aims to further evaluate the drug's efficacy, safety, and side effects compared to existing treatments.
4. New Drug Application (NDA): After successful completion of the clinical trials, the drug developers submit an NDA to the regulatory authorities, providing detailed information about the drug's manufacturing, packaging, monitoring, and administration.
5. FDA Approval: The regulatory authorities review the NDA and make a decision on whether to approve the drug for marketing and use in the general population.