Exam 1 Lecture 1

Question 1

What are Drugs?

Answer 1

substances that change biological function (in subject or an organism) through chemical action

Question 2

Primary focus of FDA

Answer 2

Enforce the federal food, drug, and cosmetic act.

Question 3

Roles of FDA

Answer 3

Oversees the drug evaluation process, and grants approval for marketing of new drug products

Question 4

FDA regulates all food except for

Answer 4

meat, poultry, and some egg products

Question 5

some FDA roles are shared with ____ , which causes problems at times

Answer 5

USDA

Question 6

FDA also enforces other was not directly related to food/drugs such as?

Answer 6

lasers, cell phones, and comdoms

Question 7

4 parts of drug development

Answer 7

1. In Vitro studies
2. Animal Testing
3. Clinical Testing
4. Marketing

Question 8

4 phases of clinical testing

Answer 8

1. testing on 20-100 subjects
2. testing on 100-200 patients
3. testing on 1000-6000 patients
4. Postmarketing surveillance

Question 9

How long does it take for a patent to expire?

Answer 9

20 years

Question 10

When do you apply for a NDA (New Drug Application)

Answer 10

after phase 3 in clinical testing (after it has been tested on 1000-6000 patients)

Question 11

When do you apply for an IND (Investigational New Drug)

Answer 11

after animal testing. When it proves to be safe in animals ,IND can be applied for to test in humans. Usually takes about 4 years to get to IND point in timeline.

Question 12

When do generics become available for drugs?

Answer 12

After patent expires in 20 years

Question 13

The first two years on the drug development timeline is composed of ______.

Answer 13

In Vitro Studies

Question 14

Amount of money on average that it takes to put a new drug on the market?

Answer 14

1 billion

Question 15

What is the CEDR?

Answer 15

FDA’s center for drug evaluation and research

Question 16

When must and IND be submitted before?

Answer 16

before initiating human clinical trials.

Question 17

What provides exemption to federal law to allow transport of drugs across state lines for clinical trials?

Answer 17

IND

Question 18

3 types of INDs

Answer 18

1. investigator IND
2. Emergency use IND
3. Treatment IND

Question 19

Info required to submit an IND

Answer 19

1. Animal pharmacology and toxicology studies
2. manufacturing information
3. clinical protocols
4. investigator information

Question 20

Application that provides for review of a generic drug application

Answer 20

ANDA

Question 21

What is an ANDA

Answer 21

Abbreviated new drug application

Question 22

Focus of ANDA is to demonstrate the product’s _____.

Answer 22

bioequivalence

Question 23

What act increased the patent length to 20 years?

Answer 23

1984 Drug Price Competition and Patent Term Restoration Act

Question 24

When do you usually apply for a patent?

Answer 24

When you apply for a NDA

Question 25

3 parts of Drug Nomenclature

Answer 25

1. Chemical name 2. Generic Name 3. Trade Name

Question 26

manufacture or brand name is termed as the drugs _____.

Answer 26

trade name

Question 27

the common name of a drug

Answer 27

generic name

Question 28

5 members of the US adopted Names Council (USAN)

Answer 28

1. AMA 2. APHa 3. USP 4. FDA 5. at large

Question 29

entity that ensures drugs for use in humans to be marketed are safe and effective

Answer 29

CEDR

Question 30

What is pharmacokinetics?

Answer 30

what the body does to a drug, | or how the drug moves/changes in the body

Question 31

5 parts to pharmacokinetics (LADME)

Answer 31

1. Liberation 2. Absorption 3. Distribution 4. Metabolism 5. Elimination

Question 32

What is medical pharmacology?

Answer 32

the science of substances used to prevent, diagnose, or treat disease.

Question 33

How can we excrete drugs?

Answer 33

through sweat, breast milk, urine, and feces

Question 34

The transformation of a drug molecule to something else

Answer 34

Metabolism

Question 35

what is pharmacodynamics?

Answer 35

What a drug does to the body

Question 36

What is pharmacotherapy?

Answer 36

How to treat disease and illness with medicine

Question 37

8 routes of drug administration

Answer 37

1. Oral (PO) 2. Rectal (PR), Vaginal (PV) 3. Intravenous (IV, IV Bolus/continuous) 4. intrathecal 5. Intramuscular (IM), Intradermal 6. topical, intraocular, intraotic 7. Subcutaneous (SubQ) 8. Intranasal

Question 38

determines appropriate route and formulation of drugs

Answer 38

Pharmaceutics

Question 39

Pharmaceutics study the ____, ____, ____, and ____ of pharmaceutical dosage forms

Answer 39

formulation, manufacture, stability, and effectiveness

Question 40

Study of variation in drug response due to variation in genes (difference how people respond to medication)

Answer 40

Pharmacogenomics

Question 41

3 types of metabolizers

Answer 41

1. poor metabolizer 2. extensive metabolizer 3. ultra- extensive metabolizer

Question 42

Poor metabolizer

Answer 42

highest serum (drug)

Question 43

extensive metabolizer

Answer 43

"normal"/expected serum drug

Question 44

ultra-extensive metabolizer

Answer 44

lowest serum (drug)

Question 45

the study of the relationship of the drug at site of action and magnitude of effect produced/ the relationship between concentration and effect

Answer 45

pharmacodynamics

Question 46

discovery, chemistry, composition, identification, bio-/physiological effects, uses and manufacture of drugs

Answer 46

pharmacology

Question 47

means by which a new drug sponsor formally proposes that the FDA approve a new pharmaceutical for sale and marketing in the US

Answer 47

NDA

Question 48

what best describes phase 1 of clinical trials?

Answer 48

main focus is on safety of the drug