EXAM2 L2

Question 1

Pharmaceutical Equivalents Def.

Answer 1

Same Active ingredient(s); same dosage form, same route of admin, identical in strength or concentration, may differ in shape, excipients, color

Question 2

Bioequivalence Def.

Answer 2

Pharm. Equivalents whose rate and extent of absorption are not statistically diff when administered to humans at the same molar dose under similar experimental conditions

Question 3

In Vivo measurement of activity moieties

Answer 3

In vivo pharmacodynamic comparison
In vivo limited clinical comparison
In vitro comparison

Question 4

T/F: Mimicry of clinical conditions is imperative in the drug making process

Answer 4

True

Question 5

T/F: Absorption windows are defined more based on physical chemical properties and not physiology

Answer 5

True

Question 6

T/F: Drug performance (PK/PD) is controlled by the interplay of excipients (formulation), the physiochemical properties of the drug, and the physiological barriers between the GI tract and site of action

Answer 6

True

Question 7

Oral formulations can control the

Answer 7

Absorption rate (Kabs) (has to be optimized with respect to disposition to yield a safe and efficacious response)

Question 8

T/F: Dosage form design is stagnant and predictable

Answer 8

False: Dynamic and unpredictable

Question 9

T/f: 60 million women are at reproductive age

Answer 9

True

Question 10

What percent of women become pregnant annually?

Answer 10

~10%

Question 11

PK of drugs in pregnancy is complex because…

Answer 11

Physiological changes alter ADME of drugs
Toxicity is a significant concern

Question 12

Fetal imprinting has been linked to….

Answer 12

Cardiovascular disease-Barker hypothesis
Neurological disorders
Obesity/diabetes

Question 13

Very difficult to predict human effects based on…

Answer 13

Many factors involved aside from genetics, e.g. diet
Many exposure studies done in animals