Final Exam Review - Exam I Flashcards
1
Q
- 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
A
A. New Chemical Entity (NCE)
2
Q
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
A
C. Bio-pharmaceutics
3
Q
- 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
A
A. The physicochemical properties an interaction of the API, excipients,
dosage form design, and associated manufacturing techniques
4
Q
- 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
A
D. Selected excipients may exert pharmacological effect in addition to the API
5
Q
5. Which of the following is NOT a route of administration? A. Oral B. Dissolution C. Dermal D. Intravenous E. Subcutaneous
A
B. Dissolution
6
Q
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
A
A. Their relative instability
C. Their large molecular weight
7
Q
- 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
A
A. True
8
Q
- 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
A
A. True
9
Q
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
A
D. Oral
10
Q
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
A
A. Drug stability in the GI environment
B. Interference from other GI contents
C. GI transit time
D. pH range
11
Q
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
A
C. Suppository
12
Q
- 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
A
A. True
13
Q
- 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
A
A. It increases surface area of a given quantity of drug
14
Q
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
A
B. Sink Conditions
15
Q
- 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
A
A. Class I – high solubility/high permeability