SOCRA CCRP Practice Exam

What stage in drug development is termed 'Safety'?

1. Phase 4

2. Phase 1

3. Phase 0

4. Pre-clinical

The correct answer is: Phase 1

Phase 4 is the post-market surveillance stage, meaning it occurs after the drug has been approved for use and is being monitored for any potential safety concerns. This is not specifically referred to as the 'Safety' stage in drug development. Phase 0, also known as exploratory studies, involves testing small doses of a drug in a small number of people to gather initial data on how the drug is processed by the body. This phase does not typically involve safety assessments. Pre-clinical refers to the stage of drug development where testing is conducted in laboratory animals to assess the safety and efficacy of a drug before it is tested in humans. While safety is an important aspect of this stage, it is not the sole focus. The 'Safety' stage in drug development is typically referred to as Phase 1. This is because Phase 1 is the first stage in which a drug is