Overview of New Drug Development Quizzes & Answers 2022

Development of most new drugs from discovery to marketing approval usually takes: 9 years or more 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? Phase II 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? Phase III Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development? Preclinical Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans? Phase I For a phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure? Preclinical data