Overview Of New Drug Development Quiz

Development of most new drugs from discovery to marketing approval usually takes:

The first randomized, controlled study of an experimental drug versus aspirin for postoperative pain control will enroll 55 subjects in each arm. Which of the following best describes the clinical phase of this study?

Adults with more than a 12-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical phase of this study?

Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?

Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?

For a phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure?