PHM321 FINAL EXAM ACTUAL 2025/2026 UPDATE

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PHM321 FINAL EXAM ACTUAL 2025/2026 QUESTIONS AND 100% CORRECT ANSWERS Question: A drug development process involves multiple stages, starting from discovery to post-marketing surveillance. At which phase of clinical research are healthy volunteers primarily used to evaluate the drug's safety and tolerability? A) Phase I B) Phase II C) Phase III D) Phase IV - Answer -Correct Answer: A) Phase I Explanation: Phase I of clinical research involves testing the drug on healthy volunteers (20-80 participants). The focus is on safety, tolerability, and determining the maximum tolerated dose. It includes single ascending dose (SAD), multiple ascending dose (MAD) studies, and food effect investigations. Question: Which phase of clinical research involves healthy volunteers to assess the safety and maximum tolerated dose of a drug? A) Phase I B) Phase II C) Phase III D) Phase IV - Answer -Correct Answer: A) Phase I Explanation: Phase I studies involve 20-80 healthy volunteers and focus on determining the safety, tolerability, and maximum tolerated dose of the drug. Question: In which phase of clinical research are patients with the disease of interest primarily recruited, with the goal of evaluating the safety and efficacy of a drug? Need assistance on Online classes, Exams & Assignments? Reach out for instant help!! Full Course Assistance, Plagiarism-free Essay Writing, Research Paper, Dissertation, Discussion Posts, etc…. Confidential & Secure services. Tutors are available for all subjects! Email now at: tutorjean01@gmail.com A) Phase I B) Phase II C) Phase III D) Phase IV - Answer -Correct Answer: B) Phase II Explanation: Phase II involves 50-300 patients who have the disease of interest. The focus is on early clinical safety and efficacy evaluation. Question: Which clinical trial phase involves large patient groups (300-3000) and is conducted to confirm the drug's safety and efficacy compared to the standard of care? A) Phase I B) Phase II C) Phase III D) Phase IV - Answer -Correct Answer: C) Phase III Explanation: Phase III trials are conducted with large patient groups (300-3000) to evaluate safety, efficacy, and compare the drug with the standard of care (SOC). Question: What is the primary objective of Phase IV clinical trials? A) To confirm safety and efficacy in healthy volunteers B) To evaluate rare or long-term adverse effects and real-world data C) To compare the drug with standard of care in large patient groups D) To test the drug on patients with the disease of interest - Answer -Correct Answer: B) To evaluate rare or long-term adverse effects and real-world data Explanation: Phase IV involves post-marketing surveillance to detect rare or long-term adverse effects and analyze real-world data. Question: Which phase of drug development involves Post-Marketing Surveillance and may result in the withdrawal or restriction of a drug if adverse effects are identified? A) Phase I B) Phase II C) Phase III Need assistance on Online classes, Exams & Assignments? Reach out for instant help!! Full Course Assistance, Plagiarism-free Essay Writing, Research Paper, Dissertation, Discussion Posts, etc…. Confidential & Secure services. Tutors are available for all subjects! Email now at: tutorjean01@gmail.com