Generic Substitution Law v2

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What is an advantage of being the first generic drug product to come to market?

180-day generic drug exclusivity

Which product meets the criteria for being a biosimilar product based on the information provided?

Same indication, dosage form, and strengths, but different preservatives than the reference product

Which products as described would be most likely to meet criteria for being therapeutically equivalent?

Brand-name and generic lisinopril 10 mg tablets that are different colors but have the same rate and extent of absorption

Based on the table, which product is therapeutically equivalent to Cardizem CD 120 mg?

Cartia XT 120 mg

What is an important point you would mention to a colleague about the process of generic drug availability?

Manufacturers must submit test results proving the generic is identical to its brand-name counterpart.

Which generic drug would be considered bioequivalent based upon mean AUC and 90% confidence interval?

The ratio of generic digoxin's mean AUC compared to the brand is 0.89 (89%) and 90% confidence interval is 0.85 to 0.94 (85% to 94%).

You receive a medication order for pantoprazole 40 mg po once daily which is nonformulary at your institution. You dispense lansoprazole to the patient. What is this an example of?

Therapeutic substitution


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