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Questions and Answers
What is the purpose of the 1938 Act mentioned in the text?
What is the purpose of the 1938 Act mentioned in the text?
What distinction did the Durham-Humphrey Amendment of 1951 introduce?
What distinction did the Durham-Humphrey Amendment of 1951 introduce?
What event led to the passing of the Kefauver-Harris Amendments of 1962?
What event led to the passing of the Kefauver-Harris Amendments of 1962?
What is the significance of an Investigational New Drug (IND) application in drug development?
What is the significance of an Investigational New Drug (IND) application in drug development?
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Which drug mentioned in the text was associated with severe birth defects like phocomelia?
Which drug mentioned in the text was associated with severe birth defects like phocomelia?
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What is the purpose of a dosage form in drug formulation?
What is the purpose of a dosage form in drug formulation?
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Which aspect of drug formulation is related to concealing bitter, salty, or offensive taste or odor of a drug?
Which aspect of drug formulation is related to concealing bitter, salty, or offensive taste or odor of a drug?
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What does the term 'dosage regimen' refer to in drug formulation?
What does the term 'dosage regimen' refer to in drug formulation?
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In drug formulation, what do dosage instructions typically include?
In drug formulation, what do dosage instructions typically include?
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Which factor is NOT a benefit provided by different dosage forms in drug formulation?
Which factor is NOT a benefit provided by different dosage forms in drug formulation?
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What is the main purpose of the Kefauver-Harris Amendments of 1962?
What is the main purpose of the Kefauver-Harris Amendments of 1962?
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Which act consolidated various laws governing stimulants, depressants, narcotics, and hallucinogens?
Which act consolidated various laws governing stimulants, depressants, narcotics, and hallucinogens?
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What is the purpose of an Investigational New Drug (IND) application?
What is the purpose of an Investigational New Drug (IND) application?
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What do the five schedules for drugs subject to abuse refer to?
What do the five schedules for drugs subject to abuse refer to?
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How did the Thalidomide tragedy impact drug regulation?
How did the Thalidomide tragedy impact drug regulation?
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What is the role of the Food and Drug Administration (FDA) in the drug development process?
What is the role of the Food and Drug Administration (FDA) in the drug development process?
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What is a key requirement for a new drug before it can be legally introduced in interstate commerce?
What is a key requirement for a new drug before it can be legally introduced in interstate commerce?
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Which of the following is NOT a goal of a drug in drug discovery and design?
Which of the following is NOT a goal of a drug in drug discovery and design?
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What regulatory requirements are outlined in the Kefauver-Harris Amendments of 1962?
What regulatory requirements are outlined in the Kefauver-Harris Amendments of 1962?
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What is the purpose of an Investigational New Drug (IND) application?
What is the purpose of an Investigational New Drug (IND) application?
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Study Notes
History of Drug Regulation
- The 1938 Act aimed to ensure the safety of drugs before they enter the market.
- The Durham-Humphrey Amendment of 1951 introduced the distinction between prescription and over-the-counter (OTC) drugs.
Kefauver-Harris Amendments of 1962
- The Kefauver-Harris Amendments were passed in response to the thalidomide tragedy, which caused severe birth defects like phocomelia.
- The main purpose of the Kefauver-Harris Amendments was to ensure the efficacy and safety of drugs before they enter the market.
Investigational New Drug (IND) Application
- An IND application is a critical step in drug development, allowing researchers to conduct clinical trials on human subjects.
- The purpose of an IND application is to gather safety and efficacy data on a new drug.
Dosage Form and Dosage Regimen
- A dosage form refers to the physical form of a drug, such as a pill or injection.
- The purpose of a dosage form is to ensure the safe and effective delivery of a drug to the patient.
- Dosage instructions typically include information on the route of administration, frequency, and duration of treatment.
- The dosage regimen refers to the specific schedule of administration of a drug.
Food and Drug Administration (FDA)
- The FDA plays a crucial role in the drug development process, overseeing the approval of new drugs.
- A key requirement for a new drug before it can be legally introduced in interstate commerce is FDA approval.
Controlled Substances
- The Comprehensive Drug Abuse Prevention and Control Act of 1970 consolidated various laws governing stimulants, depressants, narcotics, and hallucinogens.
- The five schedules for drugs subject to abuse refer to the potential for abuse, currently accepted medical use, and safety under medical supervision.
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Description
Test your knowledge on FDA regulations, drug safety, and grandfathered drugs. Learn about the history of drug regulation in the US and key points related to drug approval processes.
