Chapter 3

Question 1

How many phases are there when testing a new drug in humans?

How many number of participants in each?

Time taken?

Main purpose?

Answer 1

3 drug phases

Phase 1: 20 - 100 patients
Several months
Mainly safety

Phase 2: up to several hundred patients
Several months to 2 years
Short term safety but mainly effectiveness

Phase 3: several hundred to several thousand pat.
1 to 4 years
Safety, dosage, and effectiveness

Question 2

Pharmaceutical Equivalent

Answer 2

Drug products that contain identical amounts of the same active ingredients in the same dosage form

Question 3

Therapeutic Equivalent

Answer 3

Pharmaceutical Equivalents that produce the same effects in patients

Question 4

What is the daily sales limit of pseudoephedrine base?

Answer 4

3.6 grams per purchaser

Question 5

DEA number formula

Answer 5

Add the sum of the first, third, and fifth digits to twice the sum of the second,fourth, and sixth digits; the total should be a number whose last digit is the same as the last digit of the DEA number on the prescription

Question 6

DEA Form-224

224a

224b

Answer 6

Application for new registration

Renewal application for registration

Retail pharmacy registration affidavit for chain renewal

Question 7

DEA Form-222

Answer 7

U.S. official order forms - schedule I & II

Question 8

DEA Form-41

Answer 8

Registrants Inventory of Drugs Surrendered

Question 9

DEA Form-106

Answer 9

Report of theft or loss of controlled substance

Question 10

DEA Form-363

DEA Form-363a

Answer 10

New application registration- narcotic treatment program

Application for DEA Registration- NTP renewal registration

Question 11

DEA Form-510

Answer 11

Application for registration- for chemical registration

Question 12

How many classes of recalls are there?

Define them.

Answer 12

3 classes

Class I - Where there is a strong likelihood that the product will cause serious adverse effects or death.

Class II - where a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects

Class III - where a product is not likely to cause adverse effects

Question 13

What are the steps of the recall process?

Answer 13

1. Reports of adverse effects
2. Manufacturer agrees to the recall
3. Consumers contacted
4. Recalls listed publicly