University:
University of Wolverhampton
Course:
4PY019 | Pharmacy
Academic year:

2024
Views:

223

Pages:

2
Author:

Sara

1. What 2 things need to be proved before approving a drug? efficacy + safety of the drug 2. Who is the regulatory body of the drug development process? FDA 3. What is the second phase of clinical trial? - early exploratory + dose-finding studies in patients - evaluates the effectiveness of the drug + determines any side effects 4. What is the third phase of clin- large scale studies in patient to evaluate the ical trials? effectiveness of the drug compared to the standard treatment 5. What is the fourth phase of clinical trials? monitoring the safety of the drug in patients after the drug was administered (pharmacovigilance) 6. What regulatory body is responsible for black triangle products? European Medicines Agency (EMA) 7. What is 1 advantage of crossover trials? reduces patient variability as drug A + B is both used on the patient 8. How do we prevent particithe treatments are made to look as similiar pants from guessing which tri- as possible (e.g. active + placebo tablets al group they're in? look the same) 9. What ethics would you have to - you could be withholding an established consider with clinical trials? treatments from patients + instead, treat them with a new drug/placebo which may not show the same beneficial effects - it's also unethical to enter healthy patients into trials of harmful drugs 1/2 10. What is the power of trial? What is the power usually? - the probability of avoid a type 2 error - is usually designed to have a power between 80-90% 11. What is inclusion criteria? characteristics that must be met to be in the study; e.g. age + pop 12. What must a participant do be- subject themselves to a wide range of tests fore entering a clinical trial? to assess their eligibility; e.g. BMI, ECG, allergies etc. 2/2