BACE Pharmaceutical Development Review

Pre-clinical trials typically involve testing on:

• Human subjects

• Computer simulations only

• Animal models and cell cultures

• Marketed pharmaceutical products

The LD50 (lethal dose 50%) test in pre-clinical studies is used to determine:

• The percentage of patients who benefit from the drug

• The dose that kills 50% of test animals

• The maximum marketable dose of a drug

• The legal restrictions on drug distribution

Phase 3 clinical trials primarily assess:

• The effectiveness and safety of the drug in a large patient population

• Whether the drug is profitable for the pharmaceutical company

• The best way to manufacture the drug

• The potential for drug recalls

What is an example of an exclusion criterion for a clinical trial?

• A patient’s willingness to participate

• A medical condition that may interfere with the drug’s effectiveness

• The patient’s preference for the drug over a placebo

• A participant’s financial status

What is the main focus of in vitro pre-clinical testing?

• Testing the drug on human volunteers

• Testing the drug within living organisms

• Studying the drug’s effects on isolated cells or tissues

• Mass-producing the drug

Which regulatory agency in the U.S. reviews pre-clinical trial data before approving human testing?

• World Health Organization (WHO)

• Food and Drug Administration (FDA)

• Centers for Disease Control and Prevention (CDC)

• National Institutes of Health (NIH)

What is an adverse event in a clinical trial?

• A positive effect of the drug

• An unexpected side effect or harmful reaction to the drug

• The approval of the drug for sale

• The decision to withdraw the drug from testing

What is the primary goal of Phase 1 clinical trials?

• To determine the drug’s efficacy in a large population

• To test the drug’s safety and dosage in a small group of healthy volunteers

• To compare the drug with existing treatments

• To analyze long-term side effects

What is the role of a placebo in a clinical trial?

• To speed up the approval process

• To serve as a control for evaluating the drug’s true effects

• To ensure every participant gets active treatment

• To replace the need for a new drug

Which of the following can result in a clinical trial being terminated early?

• The drug is found to be highly effective

• The company lacks funding

• Severe safety concerns arise

• The drug is ready for market