18 Questions
What type of drug products are coded with 'B' codes?
Products that are not therapeutically equivalent to other pharmaceutically equivalent products
What is a common misconception about generic drugs?
They are not as potent as brand-name drugs
What is the main purpose of product substitution?
To ensure therapeutic equivalence
What is a benefit of generic substitution?
Reduces costs and prevents drug shortages
According to the FDA, which type of products have documented bioequivalence problems?
Drugs with documented BE problems
What type of drugs may not be suitable for generic substitution?
Hormones
What is the main factor considered by insurance providers when deciding on formularies?
Cost
What is the main purpose of the FDA guidance on therapeutic equivalence?
To ensure therapeutic equivalence
What is required before a pharmacy can request a generic substitution in Iowa?
Prescribing practitioner's approval
What is the main consideration for professionals when deciding on drug products?
Professional judgment
What phase of drug development is specific to brand-name products?
Phase 3
What is a major difference between brand-name drugs and generic drugs?
Patent terms
What is a requirement for a generic product to gain FDA approval?
Meet the same requirements for identity, strength, purity, and quality
What is therapeutic equivalence (TE) based on?
Pharmaceutical equivalence (PE) and Bioequivalence (BE)
What is the purpose of FDA's Orange Book list?
To identify multisource products and determine therapeutic equivalence
What does an 'AB' code indicate?
The product has therapeutic equivalence
What is the assumption of therapeutic equivalence (TE) products?
TE products are equally safe and effective
What is bioequivalence (BE) evaluation based on?
Cmax, tmax, and AUC
Test your knowledge of FDA drug product classification, including multisource drug products, waivers, and therapeutically equivalent products. Learn about the different categories and codes used by the FDA.
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