MODULE 1

Question 1

Initiated to define physical and chemical properties of agent

Answer 1

Preformulation studies

Question 2

Follow to develop the initial features of the proposed pharmaceutical products.

Answer 2

Formulation studies

Question 3

Examples of Pre-clinical

Answer 3

Cell culture
While animal

Question 4

If the drug demonstrate adequate safety in initial human studies, it is termed what?

Answer 4

Phase I

Question 5

Undertaken to assess safety and efficacy

Answer 5

Phase ll and lll

Question 6

Seeks approval to the market

Answer 6

NDA

Question 7

Summary of the entire drug development process

Answer 7

Package insert

Question 8

Often are sought for orphan drugs

Answer 8

Treatment IND

Question 9

Targeted for small number of patients who have rare conditions or disease.

Answer 9

Orphan drugs

Question 10

Used to gain approval to the market

Answer 10

ANDA

Question 11

Prototype chemical compound

Answer 11

Lead compound

Question 12

H2 antagonist from pioneer drug

Answer 12

Cimetidine

Question 13

This drug is a Large series of anti-anxeity drugs derived from benzodiazepine structure and innovator drug.

Answer 13

Chlordiazepoxide (Librium)

Question 14

Originally developed to treat Benign Prostatic hyperplasia (BPH)

Answer 14

Finasteride (Proscar)

Question 15

Approved to treat male pattern baldness

Answer 15

Propecia

Question 16

Term used to describe a compound thy requires metabolic biotransformation

Answer 16

Prodrug

Question 17

Their works leads to determination of whether a chemical agent possesses adequate features of safety and pursue as prospective new drug.

Answer 17

Scientist

Question 18

Develop studies that may be conducted outside the living body.

Answer 18

Scientists

Question 19

Used increasingly to screen for toxicity before whole-animal testing.

Answer 19

Cell culture

Question 20

Also known as small scale production

Answer 20

Pilot plant

Question 21

Determine dose response and dose ranging often called what?

Answer 21

Phase 2a

Question 22

Used to gather supplemental information that may support labeling request.

Answer 22

Phase 3b studies

Question 23

Tranquilizer and hypotensive agent

Answer 23

Reserpine

Question 24

First scientifically investigated and is useful for treatment of diabetes mellitus

Answer 24

Periwinkle (vinca rosea)