32 Questions
What is the primary purpose of preclinical research in drug development?
To identify potential toxicity and side effects of the drug
What is one way researchers discover new drugs?
By testing existing treatments for unanticipated effects
What do researchers investigate during the development stage of drug development?
The potential interactions with other drugs and treatments
What is the primary focus of the FDA post-market drug safety monitoring?
To identify rare side effects not detected during clinical trials
What is one way to improve the discovery of new drugs?
By using new technologies to target medical products
What is the primary purpose of the FDA drug review process?
To ensure the drug is safe and effective for use in humans
What do researchers investigate during preclinical research?
The potential benefits and toxicity of the drug
Why might a drug be withdrawn from the market or recalled?
Due to serious side effects or toxicity
What is the primary concern in human trials?
Informed consent of participants
What must be included in an Investigational New Drug (IND) application?
All of the above, plus data from prior human research and investigator information
What is drug recall?
A process for withdrawing or removing a pharmaceutical product from the market
Why was the Ranitidine Tablets recalled?
NDMA impurity
What should consumers do if they have Ranitidine Tablets subject to recall?
Discontinue use and consult with their physician or healthcare provider
Who can initiate a drug recall?
The manufacturer, wholesale dealer, or Department of Health
What is the purpose of informed consent?
To provide information about clinical trial aims and risks
What is the primary purpose of subacute toxicity studies?
To examine the effects of a drug on overt toxicity, food intake, and body weight
What is a common reason for drug recall?
All of the above, plus correct product but wrong strength
What is the duration of chronic toxicity studies?
6-12 months
What is the primary purpose of reproduction and teratogenicity studies?
To evaluate the effects of a drug on fertility and developing foetus
What is the purpose of the Ames test?
To evaluate the mutagenicity of a drug
What is the primary purpose of clinical trials?
To evaluate the safety and efficacy of a drug in humans
What is the purpose of a protocol in clinical trials?
To outline the study plan and guide the trial
What is the primary purpose of guidelines in clinical trials?
To protect participants in clinical trials
What is the purpose of reviewing prior information about a drug before designing a clinical trial?
To develop research questions and objectives
What type of test is used to detect specific activity, such as vasodilator, antibacterial, or antihistaminic?
Preliminary test
What is the purpose of mechanism of action tests?
To find out the mechanism of action
What type of test is used to study the effects of a drug on major organ systems?
Systemic pharmacology
What is the purpose of acute toxicity tests?
To determine the toxicity of the compound
What type of test is used to study the absorption, distribution, and excretion of a drug?
Pharmacokinetics
What is the purpose of general observational tests?
To observe the overt effects of a drug
What type of test is used to confirm and characterize the activity of a drug?
Confirmatory test
What is the purpose of quantitative tests?
To ascertain the dose-response relationship
This quiz covers the process of drug development, including discovery, preclinical trials, and human testing phases. It also explores reasons for drug withdrawal and recall.
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