Final Exam Review - Exam I

Question 1

1. A chemical compound entering drug development that has never been administered to a human is formally called a/an:
   A. New Chemical Entity (NCE)
   B. Active ingredient
   C. Drug substance
   D. Active Pharmaceutical Ingredient (API)
   E. Drug Candidate

Answer 1

A. New Chemical Entity (NCE)

Question 2

2. The study of the interactions between the physical and chemical properties of a drug and drug product with the anatomy and physiology and biochemistry of the biological system defines:
A.	Pharmaceutics
B.	Pharmacokinetics
C.	Bio-pharmaceutics
D.	Pharmacology

Answer 2

C. Bio-pharmaceutics

Question 3

3. Pharmaceutics is the study of:
   A. The physicochemical properties an interaction of the API, excipients,
   dosage form design, and associated manufacturing techniques
   B. The pharmacologic and toxicologic effects that drugs have on the body
   C. The anatomical, physiological and biochemical affects the body has on drugs
   D. The functional groups of drugs and how molecules are designed and chemically
   synthesized
   E. The proper procedures for dispensing of drug products and patient counseling

Answer 3

A. The physicochemical properties an interaction of the API, excipients,
dosage form design, and associated manufacturing techniques

Question 4

4. Most drug products are formulated form the active pharmaceutical ingredient and various experts. Which of the following statements is not a reason for drug product formulation:
   A. Selected excipients may improve the stability and shelf life of the API
   B. Selected excipients may allow targeted delivery of the API to the desired side of
   absorption.
   C. Selected excipients may improve the dissolution properties of the API
   D. Selected excipients may exert pharmacological effect in addition to the API
   E. Selected excipients may improve acceptability of the drug product to the patient
   and enhance patient compliance

Answer 4

D. Selected excipients may exert pharmacological effect in addition to the API

Question 5

5. Which of the following is NOT a route of administration? 
A. Oral
B. Dissolution
C. Dermal
D. Intravenous
E. Subcutaneous

Answer 5

B. Dissolution

Question 6

6. What is the primary physicochemical limitation of biopharmaceutical/biologic drugs that minimizes options for route of administration? Select all:
A. Their relative instability
B. Their variable toxicity
C. Their large molecular weight
D. Their solubility
E. Their pka

Answer 6

A. Their relative instability

C. Their large molecular weight

Question 7

7. The primary overall factors guiding design of dosage forms are bio-pharmaceutics; physiochemical characteristics of the API; and therapeutic intent (including drug target, indication, patient satisfaction)
   A. True
   B. False

Answer 7

A. True

Question 8

8. The physiochemical properties of a drug that contribute to the passive diffusion rate across biological membranes are lipid solubility and degree of ionization
   A. True
   B. False

Answer 8

A. True

Question 9

9. What route of admin of a drug requiring systemic distribution would you generally expect to result in the slowest onset of action?
A. IV
B. Rectal
C. Inhalation 
D. Oral
E. Intranasal

Answer 9

D. Oral

Question 10

10. Which of the following factors can significantly affect a drugs oral absorption? Select all:
A. Drug stability in the GI environment
B. Interference from other GI contents
C. GI transit time
D. pH range
E. Expiry date of the drug product

Answer 10

A. Drug stability in the GI environment
B. Interference from other GI contents
C. GI transit time
D. pH range

Question 11

11. Which of the following dosage form would be useful for vomiting or unconscious puts?
A. Tablet
B. Capsule
C. Suppository
D. Metered dose inhaler
E. Oral solution

Answer 11

C. Suppository

Question 12

12. Theoretically the onset of action of a drug in solution will be faster than it will be from a capsule or tablet.
    A. True
    B. False

Answer 12

A. True

Question 13

13. Considering the Whitney-Noyes equation, why should particle size reduction increase a drug’s dissolution and absorption rate?
    A. It increases surface area of a given quantity of drug
    B. It decreases the amount of drug required per dosage unit for the same
    therapeutic effect
    C. It decrease the surface area of a given quantity of drug
    D. It converts stable polymorphs to the amorphous form of the drug
    E. It increase the logP of the drug

Answer 13

A. It increases surface area of a given quantity of drug

Question 14

14. During in vitro dissolution testing, if the concentration of drug dissolved in the bulk solution does NOT exceed 10-15% of the drug’s saturation concentration at the solid/solvent interface in the aqueous diffusion layer, the dissolution test is said to operate under \_\_\_\_?
A. Stress Conditions
B. Sink Conditions
C. Saturation conditions
D. Physiological conditions
E. Optimized conditions

Answer 14

B. Sink Conditions

Question 15

15. According to the Bio pharmaceutics Classification System, if the highest dosage strength of a drug is soluble in 90% of the dose then the drug is considered to be:
    A. Class I – high solubility/high permeability
    B. Class II – low solubility/high permeability
    C. Class IV – high solubility/low permeability
    D. Class V – low solubility/low permeability
    E. Class VI – insoluble/impermeable

Answer 15

A. Class I – high solubility/high permeability

Question 16

16. Which of the following is a stage of drug development in which pharmaceutical scientists determine and characterize the physicochemical properties of a New Chemical Entity?
A. Drug discovery
B. Preformulation
C. Dosage form development
D. Phase 1
E. Preclinical development

Answer 16

B. Preformulation

Question 17

17. The physicochemical properties of a compound that can only be changed by chemical modification of the compound are classified as \_\_?
A. Derived properties
B. Drug-like properties
C. Intrinsic properties
D. Developability
E. Manufacturability

Answer 17

C. Intrinsic properties

Question 18

18. Which of the following is NOT one of the primary intrinsic physicochemical properties tested during preformulation?
A. Solubility
B. pKa
C. Po/w / LogP
D. Hygroscopicity
E. Organoleptic characteristics

Answer 18

E. Organoleptic characteristics

Question 19

19. A compound that is in an amorphous state would be expected to have no definite, measurable melting point and a higher solubility than a stable polymorph.
    A. True
    B. False

Answer 19

A. True