6 Questions
What may the FDA require if some differences between a proposed drug product and a previously approved drug product can affect bioavailability?
In vivo studies
Which of the following is NOT a variable that can contribute to differences between drug products?
Temperature during storage
Why are bioequivalency problems more significant among tablets compared to other dosage forms?
Due to variations in the manufacturing process
What factor can vary in tablets based on the punches, dies, and compression forces used in the manufacturing process?
Hardness
How can the integrity of tablets be altered during packaging, shipping, and storage?
All of the above
What may affect the rates of tablet disintegration, drug dissolution, and drug absorption?
All of the above
Learn about the FDA requirements for in vivo studies related to drug products and how differences between proposed and approved products can affect bioavailability and therapeutic equivalence. Explore the variables that can contribute to product differences according to FDA regulations.
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