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Questions and Answers
What may the FDA require if some differences between a proposed drug product and a previously approved drug product can affect bioavailability?
What may the FDA require if some differences between a proposed drug product and a previously approved drug product can affect bioavailability?
- Phase 1 clinical trials
- Post-marketing surveillance
- In vitro studies
- In vivo studies (correct)
Which of the following is NOT a variable that can contribute to differences between drug products?
Which of the following is NOT a variable that can contribute to differences between drug products?
- Color of the tablet
- Shape of the tablet
- Temperature during storage (correct)
- Particle size
Why are bioequivalency problems more significant among tablets compared to other dosage forms?
Why are bioequivalency problems more significant among tablets compared to other dosage forms?
- Because tablets have more ingredients
- Due to variations in the manufacturing process (correct)
- Tablets are not stable during shipping
- The FDA requires more stringent testing for tablets
What factor can vary in tablets based on the punches, dies, and compression forces used in the manufacturing process?
What factor can vary in tablets based on the punches, dies, and compression forces used in the manufacturing process?
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How can the integrity of tablets be altered during packaging, shipping, and storage?
How can the integrity of tablets be altered during packaging, shipping, and storage?
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What may affect the rates of tablet disintegration, drug dissolution, and drug absorption?
What may affect the rates of tablet disintegration, drug dissolution, and drug absorption?
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