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Florida A&M University PHARMACY PHA 3102 Drug Delivery II Practice Problems and Quiz 1 1)What are the 6 characteristics of a goal drug? 2
Florida A&M University
PHARMACY PHA 3102
Drug Delivery II Practice Problems and Quiz 1
1)What are the 6 characteristics of a goal drug?
2. What is a lead compound?
3. What is a prodrug?
4. Name the 4 areas that preformulation studies focus on:
5. Define dissolution rate?
6. What is Phase 1 of a clinical investigation?
7. What is Phase 2 of a clinical investigation?
8. What is Phase 3 of a clinical investigation?
9. What is Phase 4 of a clinical investigation?
10. What is a Usual adult dose?
11. What is a Usual pediatric dose?
12. What is a Dosage regimen?
13. What is a Initial dose?
14. What is a loading dose?
15. What is a Maintenance dose?
16. What is a Prophylactic dose?
17. What is a Therapeutic dose?
18. What is the difference between a drug and a poison?
19. Therapeutic orphans are pediatric patients who:
a. Do not have access to medicines
b. Have lost parents
c. Use unlicensed medicines
d. Are treated by the government
e. Do not have access to medical care
20. The risks of extemporaneous compounding include:
a. The potential for calculation errors
b. Selecting incorrect ingredient
c. Assignment of arbitrary shelflife
d. Incorrect quantities e. All of the above
21. Which of the statements is false regarding the shelflife of compounded liquid products?
a. It is necessary to use preservatives in all products
b. They usually have or no supporting stability data
c. The expiry date is usually assigned arbitrary
d. Compound hydroxylbenzoate solution is sometimes used as preservative
e. It is the best described as a beyond use date
22. Which of the following is the legal source of cGMPs requirements for FDAapproved human drug?
a.The code of Federal Regulation
b. The Federal Register
c. The NABP Model State Pharmacy Act
d. The USP
E. The FDA Compliance Policy Guide
23. All of the following c are subject to regulation by cGMPs except:
a. Implantable insulin infusion
b. Peptides produced by recombinant DNA technology
c. Heparin prefilled syringes
d. Empty plastic prescription vials
e. Intravenous catheters impregnated with antibiotics
24. All of the following statements regarding the regulations on tamperresistant packaging are true except:
a. Pharmaceutical manufacturers have the option of determining the type of tamper resistant packing to use
b. Some categories of OTCs sold in pharmacies are exempt from this packaging
c. This regulation applies to all OTC products distributed for institutional use
d. Film wrapper, shrink bands, and bubble packs are acceptable packaging types for OTC products
e. Barriers may involve the immediate drug product container and/or outer container or carton
25. Which of the following are appropriate compounding practices? Preparation of components into formulation: (Select all that apply).
a. For the purpose of research or teaching
b. For chemical analysis and not for sale or dispensing c. For a patient as the result of a prescription drug order
d. For resale by other local pharmacies
e. In the limited amounts in anticipation of receiving prescription drug order
26. Which of the following factors best differentiate between pharmaceutical compounding and manufacturing?
a.A practitioner’s prescription for specific patients b. The duration of treatment with the particular drug
c. The quantity of medication in each batch of a lot
d. How many compounded prescriptions in each batch
e. The distance between the drug preparation and usage location
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