Intro

Question 1

Agent intended to be use in** diagnosis, mitigation, treatment, cure**, or prevention of disease in MAN & other **animals **
Agents intended to affect the structure & function of the body of man & other animals

Answer 1

Drugs

Question 2

Any component, other than active subs, present in medicinal product or used in the manufacture of the product

Answer 2

Additive/ Excipients/ Pharmaceutic Necessities/ Adjuncts

Question 3

Protoype chemical compound that has funadamental desired biologic or pharmacologic activity

Answer 3

Lead Compound

Question 4

A drug or biologic product for the diagnosis, treatment, or prevention of a rare disease or condition

Answer 4

Orphan Drug

Question 5

Disease that affects fewer than 200,000 persons in the US, or >200,000 person but w/o reasonable expectation that the cost of developing and marketing the drug will be recovered from sales

Answer 5

Rare Disease

Question 6

Drug products/preparations containing Active Pharmaceutical Ingredient (API)/ Drug

Answer 6

Dosage Forms

Question 7

Dosage form that does not contain an API

Answer 7

Placebo

Question 7

Preparation, mixing, packaging or labeling of a drug to prepare an individualized drug treatment for a patient

Answer 7

Compounding

Question 8

Reasons for Dosage Form Formulation

Answer 8

appearance, palatability, ease of administration, solubility, stability