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1. Which of the following statements is TRUE regarding the Hatch-Waxman Act:

A. It does not allow brand-name drug companies to apply for patent extensions B. It requires animal and human testing for generic drug approval C. It allows generic drug companies to submit an abbreviated new drug application (ANDA) rather than an NDA D. It does not require the U.S. Food and Drug Administration (FDA) to publish a list of approved drug products

2. Which of the following terms refers to the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of action:

A. Bioavailability B. Average bioequivalence C. Scaled average bioequivalence D. Volume of distribution

3. Which therapeutic equivalence rating would a topical drug product receive if it is considered to be therapeutically equivalent to its reference listed drug?

A. BT B. AO C. AT D. BD

4. For bioequivalence studies performed in the fed state, the typical test meal includes how many calories from fat?

A. 150 B. 250 C. 500 D. 300

5. According to the U.S. Food and Drug Administration (FDA), the average population ratios for the AUC and C_max of generic products cannot differ from their reference listed drug by more than what percentage?

A. 20% B. 30% C. 5% D. 15%

6. According to a review of 2070 bioequivalence studies of FDA-approved generic drug products, the average difference in AUC and C_maxbetween brand-name and generic drugs was which of the following:

A. Less than 2% B. 10% C. Less than 5% D. 15%

7. With regard to formulation changes of narrow therapeutic index (NTI) drugs, neurologists and transplant physicians recommend all of the following, EXCEPT:

A. Therapeutic drug monitoring during the transition from one drug formulation to another B. The patient is notified of the potential change C. The provider is notified of the potential change D. Bioequivalence studies are only to be performed in healthy volunteers

8. Which of the following statements is FALSE regarding generic bioequivalence studies:

A. Bioequivalence studies compare the rate and extent of absorption of a generic drug with that of a reference listed drug product B. Generic drug products are tested to determine if they are bioequivalent to each other C. Bioequivalence studies are typically performed in 24 to 36 healthy volunteers D. Some generic drug products are approved using in-vitro studies in place of in-vivo studies

9. The FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee has recommend all of the following changes/additions to bioequivalence studies, EXCEPT:

A. Tighter bioequivalence acceptance limits for NTI drugs B. A list of NTI drugs with clear, specific criteria for including drugs on the list C. Application of a scaled average bioequivalence model D. Pharmacokinetic comparisons of AUC values only

10. All of the following statements are TRUE, EXCEPT:

A. The Orange Book does not include drugs that were approved only on the basis of safety B. The Orange Book is required by law to be used in every state C. The Orange Book does not include drugs that have received tentative approval D. The Orange Book does not include pre-1938 drugs