Good Clinical Practice (GCP) 2024 Questions with 100% Correct Answers | Verified | Latest Update

Good Clinical Practice (GCP) 2024 Questions with 100% Correct Answers | Verified | Latest Update.1. Which of the following are the three principles included in the Belmont Report ANS Respect for Persons, Beneficence, Justice. 2. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects ANS Determining that the study has maximized benefits and minimized risks. 3. Which of the following best describes the principle of Respect for Persons ad described in the Belmont Report ANS Information, comprehension, voluntariness. 4. Development of most new drugs from discovery to marketing approval usually takes ANS 9 years or more 5. 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 ANS Phase III 6. Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development ANS Preclinical 7. Pharmacokinetics and pharmacodynamics of a new formulation of an in- vestigational drug most likely refers to which clinical phase of a study in humans ANS Phase I