Pharmacology: Drug Development and Safety

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What is the primary purpose of preclinical research in drug development?

To compare the drug with similar drugs on the market

To determine the optimal dosage of the drug

To identify potential toxicity and side effects of the drug (correct)

To test the effectiveness of the drug in humans

What is one way researchers discover new drugs?

By reviewing medical literature and publications

By conducting surveys of medical professionals

Through clinical trials with human subjects

By testing existing treatments for unanticipated effects (correct)

What do researchers investigate during the development stage of drug development?

The best marketing strategy for the drug

The potential interactions with other drugs and treatments (correct)

The optimal pricing for the drug

The most effective way to patent the drug

What is the primary focus of the FDA post-market drug safety monitoring?

To identify rare side effects not detected during clinical trials Signup and view all the answers

What is one way to improve the discovery of new drugs?

By using new technologies to target medical products Signup and view all the answers

What is the primary purpose of the FDA drug review process?

To ensure the drug is safe and effective for use in humans Signup and view all the answers

What do researchers investigate during preclinical research?

The potential benefits and toxicity of the drug Signup and view all the answers

Why might a drug be withdrawn from the market or recalled?

Due to serious side effects or toxicity Signup and view all the answers

What is the primary concern in human trials?

Informed consent of participants Signup and view all the answers

What must be included in an Investigational New Drug (IND) application?

All of the above, plus data from prior human research and investigator information Signup and view all the answers

What is drug recall?

A process for withdrawing or removing a pharmaceutical product from the market Signup and view all the answers

Why was the Ranitidine Tablets recalled?

NDMA impurity Signup and view all the answers

What should consumers do if they have Ranitidine Tablets subject to recall?

Discontinue use and consult with their physician or healthcare provider Signup and view all the answers

Who can initiate a drug recall?

The manufacturer, wholesale dealer, or Department of Health Signup and view all the answers

What is the purpose of informed consent?

To provide information about clinical trial aims and risks Signup and view all the answers

What is the primary purpose of subacute toxicity studies?

To examine the effects of a drug on overt toxicity, food intake, and body weight Signup and view all the answers

What is a common reason for drug recall?

All of the above, plus correct product but wrong strength Signup and view all the answers

What is the duration of chronic toxicity studies?

6-12 months Signup and view all the answers

What is the primary purpose of reproduction and teratogenicity studies?

To evaluate the effects of a drug on fertility and developing foetus Signup and view all the answers

What is the purpose of the Ames test?

To evaluate the mutagenicity of a drug Signup and view all the answers

What is the primary purpose of clinical trials?

To evaluate the safety and efficacy of a drug in humans Signup and view all the answers

What is the purpose of a protocol in clinical trials?

To outline the study plan and guide the trial Signup and view all the answers

What is the primary purpose of guidelines in clinical trials?

To protect participants in clinical trials Signup and view all the answers

What is the purpose of reviewing prior information about a drug before designing a clinical trial?

To develop research questions and objectives Signup and view all the answers

What type of test is used to detect specific activity, such as vasodilator, antibacterial, or antihistaminic?

Preliminary test Signup and view all the answers

What is the purpose of mechanism of action tests?

To find out the mechanism of action Signup and view all the answers

What type of test is used to study the effects of a drug on major organ systems?

Systemic pharmacology Signup and view all the answers

What is the purpose of acute toxicity tests?

To determine the toxicity of the compound Signup and view all the answers

What type of test is used to study the absorption, distribution, and excretion of a drug?

Pharmacokinetics Signup and view all the answers

What is the purpose of general observational tests?

To observe the overt effects of a drug Signup and view all the answers

What type of test is used to confirm and characterize the activity of a drug?

Confirmatory test Signup and view all the answers

What is the purpose of quantitative tests?

To ascertain the dose-response relationship Signup and view all the answers