Overview Of New Drug Development Quiz

12 September 2022
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6 test answers
question
Development of most new drugs from discovery to marketing approval usually takes:
answer
9 years or more
question
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?
answer
Phase II
question
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?
answer
Phase III
question
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?
answer
Preclinical
question
Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?
answer
Phase I
question
For a phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure?
answer
Preclinical data
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question
Development of most new drugs from discovery to marketing approval usually takes:
answer
9 years or more
question
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?
answer
Phase II
question
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?
answer
Phase III
question
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?
answer
Preclinical
question
Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?
answer
Phase I
question
For a phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure?
answer
Preclinical data