Drug Evaluation

Question 1

Role of federal government in prescriptions

Answer 1

control what drugs can be prescribed/sold, regulates evaluation of new drugs (safety/efficacy), equivalency for generics, classification as prescription vs OTC

Question 2

State role in prescriptions

Answer 2

control over who can prescribe drugs–need license through state

Question 3

Local role in prescriptions

Answer 3

can regulate certain drugs in their jurisdiction (medical marijuana)

Question 4

Length of clinical trials

Answer 4

2-10 years
Preclinical (5-8)
Phase (1-2)
Phase II (2)
Phase III (3)
Phase IV (ongoing)

Question 5

Subjects in Clinical trials

Answer 5

Preclinical - animals
Phase I- healthy (M)/18-24 yo (20-100 ppl)
Phase II- 100-300 pts with targeted disease
Phase III 1000-3000 pts in clinical setting

Question 6

Purpose of Each Phase of Clinical trials

Answer 6

Preclinical- determine safe dosage for humans (carcinogenic? effect on reproductive performance?
Phase I- gather Pharmacokinetic data; see if safe in humans
Phase II - evaluate safety/efficacy; final dosing/regimen adjustments
Phase III - measure efficacy vs std therapy/monitor adverse reactions for chronic use
Phase IV - collect data on morbidity/mortality, safety, increased risk groups, adverse effects

Question 7

Dietary Supplement

Answer 7

vitamins, minerals, amino acids, herbs intended to supplement diet

Question 8

Label requirements for dietary supplements

Answer 8

name of product, net quantity of contents, manufacturer info, directions for use

Question 9

Pharmaceutical equivalence

Answer 9

same drug formulation (active ingredients, dosage formulation, route of admin, strength/concentration)

Question 10

Pharmaceutical alternative

Answer 10

same therapeutic moiety but different salts, esters/complexes of moiety and different dosage forms/strengths

Question 11

Bioequivalence

Answer 11

dependent on rate and extent active ingredient is absorbed from formulation and becomes available in plasma

Question 12

Bioavailability

Answer 12

(F) amount of drug that gets into plasma; represented by area under the curve in plasma concentration vs time curve

Question 13

Bioequivalence

Answer 13

Generic bioequivalent to brand if rate of absorption AND extent of drug absorption within 80-125% of that of brand product

Question 14

Therapeutic equivalence

Answer 14

assumed if bioequivalence met