Podcast
Questions and Answers
What was the primary focus of the 1962 Kefauver-Harris Amendments?
What was the primary focus of the 1962 Kefauver-Harris Amendments?
- Promoting drug price competition
- Establishing the FDA
- Encouraging pharmaceutical innovation
- Ensuring products are safe and effective (correct)
What is the term for pharmaceutical products that have the same drug, dosage form, route of administration, and strength?
What is the term for pharmaceutical products that have the same drug, dosage form, route of administration, and strength?
- Pharmaceutical equivalence (correct)
- Generic equivalence
- Therapeutic equivalence
- Bioequivalence
According to the FDA's bioequivalence range, what is the acceptable percentage range for Cmax and AUC?
According to the FDA's bioequivalence range, what is the acceptable percentage range for Cmax and AUC?
- 80-125% (correct)
- 90-110%
- 70-130%
- 80-120%
What is the primary reason for generic prescription substitution?
What is the primary reason for generic prescription substitution?
What is the requirement for pharmacies in Iowa before substituting a lower-priced generic or TE drug for a higher-priced prescribed drug?
What is the requirement for pharmacies in Iowa before substituting a lower-priced generic or TE drug for a higher-priced prescribed drug?
What is the primary purpose of the FDA's Orange Book List?
What is the primary purpose of the FDA's Orange Book List?
What does an 'AB' code indicate on the FDA's Orange Book List?
What does an 'AB' code indicate on the FDA's Orange Book List?
What type of drugs may not be appropriate for substitution with generic subs?
What type of drugs may not be appropriate for substitution with generic subs?
What does the 'B' code category on the FDA's Orange Book List refer to?
What does the 'B' code category on the FDA's Orange Book List refer to?
What is the purpose of the TE codes on the FDA's Orange Book List?
What is the purpose of the TE codes on the FDA's Orange Book List?
