intro to pharm sci exam 1

Which statement is true for drug development and regulatory process?

a) FDA stands for the Federal Defense Agency

b) Investigational new drug application is commonly known as NDA

c) Genetic field of drug development includes recombinant DNA and monoclonal antibody technologies as well as gene therapy

d) Phase I clinical trials are usually carried out in patients and not in healthy individuals

c) Genetic field of drug development includes recombinant DNA and monoclonal antibody technologies as well as gene therapy

Which statement is true for the drug development and regulatory process?

a) A drug's sponsor must submit an IND before a Phase 1 trial of a drug.

b) An NDA must precede an IND submission to the FDA.

c) An NDA approval does not precede a corresponding ANDA submission.

d) Center for Biologics Evaluation and Research is commonly known as CDER

a) A drug's sponsor must submit an IND before a Phase 1 trial of a drug.

Which of the following statements reflects the limitation of pH Partition Theory?

a) Large surface area of the small intestine compensates for ionization effects

b) Charged drugs can never be efficiently absorbed by the small intestine

c) Drugs are always absorbed via simple diffusion

d) Drug absorption is not affected by its lipophilicity

a) Large surface area of the small intestine compensates for ionization effects

Which equation is used to calculate drug dissolution rate?

a) Stoke's equation

b) Henderson-Hasselbach equation

c) Fick's equation

d) Noyes-Whitney equation

d) Noyes-Whitney equation

The diffusion coefficient of a permeant depends on

a) Diffusion medium

b) Diffusion length

c) Temperature

d) All of the above

d) All of the above

Aspirin often causes gastric bleeding because it is:

a) Highly ionized in the stomach

b) Highly unionized in the intestine

c) Highly unionized in the stomach

d) Its ionization is independent of pH

c) Highly unionized in the stomach

Logarithm of partition coefficient (P), known as log P, is a measure of

a) Dissociation constant of the drug

b) Stability of the drug

c) Lipophilicity of the drug

d) Absorption of the drug

c) Lipophilicity of the drug

A drug's aqueous solubility may be enhanced by all of the following except:

a) Cosolvency

b) Salt formation

c) Micronization

d) Interaction with oppositely charged ions

d) Interaction with oppositely charged ions

The extent of ionization of a weak electrolyte drug is dependent on the:

a) pH of the media and pKa of the drug

b) Oil water partition coefficient of the drug

c) Particle size and surface area of the drug

d) Noyes-Whitney equation for the drug

a) pH of the media and pKa of the drug

The k in the Noyes-Whitney's equation dM/dt=DS (Cs-C)/h = kS (Cs-C) stands for:

a) Dissolution rate constant

b) Diffusion coefficient

c) Partition coefficient

d) Permeability coefficient

a) Dissolution rate constant

Which of the following statements is FALSE?

a) The partition coefficient is the ratio of drug solubility in n-octanol to that in water.

b) Absorption of a weak electrolyte drug does not depend on the extent to which the drug exists in its unionized form at the absorption site.

c) Amorphous forms of drug have faster dissolution rates than crystalline forms.

d) All of the above.

b) Absorption of a weak electrolyte drug does not depend on the extent to which the drug exists in its unionized form at the absorption site.

The pH of a buffer system can be calculated with:

a) Henderson-Hasselbach equation

b) Noyes-Whitney equation

c) Michaelis-Menten equation

d) Yang's equation

e) All of the above

a) Henderson-Hasselbach equation

The characteristics of an active transport process include all of the following, except:

a) Active transport moves drug molecules against a concentration gradient.

b) It follow's Fick's law of diffusion.

c) It is a carrier-mediated transport system.

d) It requires energy.

e) Active transport of drug molecules may be saturated at high drug concentrations.

b) It follow's Fick's law of diffusion.

The passage of drug molecules from a region of high drug concentration to the region of low drug concentration is known as:

a) Active transport

b) Simple diffusion or passive transport

c) Pinocytosis

d) Bioavailability

e) Biopharmaceutics

b) Simple diffusion or passive transport

Which of the following is true of Fick's first law of diffusion?

a) It refers to a non-steady-state flow

b) The amount of material flowing through a unit cross section of barrier in unit time is known as the concentration gradient.

c) Flux of material is proportional to the concentration gradient.

d) Diffusion occurs in the direction of increasing concentration.

e) All of the above.

c) Flux of material is proportional to the concentration gradient.

The rate of drug dissolution from a tablet dosage form will be dependent on

a) Particle size of the drug

b) Surface area of drug particles

c) All of the above

c) All of the above

The permeability coefficient of a weak electrolyte through a biological membrane will depend on:

a) Diffusion coefficient

b) Membrane thickness

c) Partition coefficient increases

d) All of the above

d) All of the above

Indicate which statement is true.

a) Fick's first law of diffusion states that the amount of material flowing through a unit cross section of a barrier in unit time is proportional to the concentration gradient.

b) Diffusion coefficient is constant.

c) Under the sink condition, the drug concentration in the receptor compartment is higher than the donor compartment.

a) Fick's first law of diffusion states that the amount of material flowing through a unit cross section of a barrier in unit time is proportional to the concentration gradient.

Factors influencing dosage form design include:

a) Molecular size and volume

b) Drug stability, solubility, and pH

c) Partition coefficient

d) Particle size and dissolution rate

e) All of the above

e) All of the above

The term gene therapy refers to a method

DNA as drug to treat disease

The rate of drug dissolution from a tablet dosage form will increase with:

A. The particle size of the drug

B. The surface area of drug particles

C. The disintegration time

D. The amount of excipients to dilute the drug

B. The surface area of drug particles

The permeability coefficient of a weak electrolyte through a biological membrane will increase if:

A. The particle size of the drug increases.

B. The surface area of drug particles increases.

C. The partition coefficient increases.

D. The drug dissolution rate increases.

C. The partition coefficient increases.

When the rate of absorption is decreased:

A. The Cmax is lowered and Tmax occurs at a later time

B. The Cmax is increased and Tmax occurs at a later time

C. The Cmax is not changed but Tmax occurs at a later time

D. None of the above

A. The Cmax is lowered and Tmax occurs at a later time

Which one of the following statements is true about absorption of drugs that are absorbed by passive diffusion?

A. Lower partition coefficient (K) favors absorption

B. Higher surface area favors absorption

C. Smaller diffusion coefficient (D) favors absorption

B. Higher surface area favors absorption

Delay in gastric emptying of a drug formulation may:

A. slow the rate of drug absorption

B. Increase the rate of drug absorption

A. slow the rate of drug absorption

Chloroquine is an antimalarial drug with volume of distribution of 13,000 L. What can we conclude?

A. The drug binds strongly to a protein in tissues

B. The drug is distributed mostly in the vascular compartment

C. It is physically impossible for any drug to have VD so high

A. The drug binds strongly to a protein in tissues

Which of the following types of reactions does NOT belong to the phase I metabolism?

A. Conjugation

B. Hydrolysis

C. Reduction

D. Oxidation

A. Conjugation

Renal clearance of a new drug was compared with the clearance of insulin and the clearance ratio was determined to be 1.5. What conclusion can be made about the mechanism of renal clearance of the new drug?

A. Drug is partially reabsorbed

B. Drug is cleared by glomerular filtration only

C. Drug is actively secreted

C. Drug is actively secreted