Drug Development and Clinical Trials

Only if the drug shows promise in Phase 3 human trials

Before the preclinical studies demonstrate adequate safety

After the drug demonstrates adequate safety in preclinical studies (correct)

After Phase 1 human studies demonstrate safety and efficacy

To design labeling and packaging

To develop manufacturing scale-up and process controls

To define the agent’s basic and clinical pharmacology

To assess safety and efficacy (correct)

Preclinical studies to assess safety

Proposed labeling and package design

Product design and development

Laboratory work toward defining the agent’s basic and clinical pharmacology (correct)