Podcast
Questions and Answers
What is the term for a compound that shows pharmacological activity and is used as a starting point for drug development?
What is the term for a compound that shows pharmacological activity and is used as a starting point for drug development?
What is the primary focus of preclinical and toxicity testing of drug products?
What is the primary focus of preclinical and toxicity testing of drug products?
What is the purpose of an Analytical Research Study in drug development?
What is the purpose of an Analytical Research Study in drug development?
What is the term for the application submitted by a pharmaceutical company to the FDA to market a new drug in the United States?
What is the term for the application submitted by a pharmaceutical company to the FDA to market a new drug in the United States?
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What do measures of risk related to a clinical trial help to determine?
What do measures of risk related to a clinical trial help to determine?
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What is the purpose of preclinical safety and toxicity testing in drug development?
What is the purpose of preclinical safety and toxicity testing in drug development?
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What is the role of Claimed Investigational Exemption for a New Drug (IND) in the drug development process?
What is the role of Claimed Investigational Exemption for a New Drug (IND) in the drug development process?
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What do measures of risk related to a clinical trial help to determine?
What do measures of risk related to a clinical trial help to determine?
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What are the advantages of analytical research studies in drug development?
What are the advantages of analytical research studies in drug development?
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What are the 5 steps in the drug development process?
What are the 5 steps in the drug development process?
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Study Notes
Drug Development Process
- A lead compound is a compound that shows pharmacological activity and is used as a starting point for drug development.
Preclinical and Toxicity Testing
- The primary focus of preclinical and toxicity testing of drug products is to assess the safety and efficacy of the drug in laboratory animals before moving to human clinical trials.
Analytical Research Studies
- The purpose of an Analytical Research Study in drug development is to characterize and validate the methods used to analyze the drug, including its purity, potency, and stability.
New Drug Application (NDA)
- The term for the application submitted by a pharmaceutical company to the FDA to market a new drug in the United States is a New Drug Application (NDA).
Clinical Trials
- Measures of risk related to a clinical trial help to determine the probability of adverse events and the benefit-risk ratio of the drug.
Preclinical Safety and Toxicity Testing
- The purpose of preclinical safety and toxicity testing in drug development is to identify potential risks and hazards associated with the drug and to estimate the doses that are likely to be safe for human testing.
Claimed Investigational Exemption for a New Drug (IND)
- The role of Claimed Investigational Exemption for a New Drug (IND) in the drug development process is to allow the pharmaceutical company to conduct clinical trials in humans before the drug is approved for marketing.
Advantages of Analytical Research Studies
- The advantages of analytical research studies in drug development include improved drug quality, increased efficiency, and reduced costs.
Steps in the Drug Development Process
- The 5 steps in the drug development process are:
- Discovery and lead optimization
- Preclinical development
- Clinical development
- Registration and approval
- Post-marketing surveillance
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Description
Test your knowledge of drug design and development, including approaches to developing new drugs, sources of active compounds, preclinical and toxicity testing, and the various steps taken by regulatory bodies before and after the entry of drug products into clinical trials.
