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MUSC Pharmacology > Exam 1 Lecture 1 > Flashcards

Exam 1 Lecture 1 Flashcards

1
Q

What are Drugs?

A

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

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2
Q

Primary focus of FDA

A

Enforce the federal food, drug, and cosmetic act.

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3
Q

Roles of FDA

A

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

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4
Q

FDA regulates all food except for

A

meat, poultry, and some egg products

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5
Q

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

A

USDA

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6
Q

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

A

lasers, cell phones, and comdoms

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7
Q

4 parts of drug development

A
  1. In Vitro studies
  2. Animal Testing
  3. Clinical Testing
  4. Marketing
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8
Q

4 phases of clinical testing

A
  1. testing on 20-100 subjects
  2. testing on 100-200 patients
  3. testing on 1000-6000 patients
  4. Postmarketing surveillance
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9
Q

How long does it take for a patent to expire?

A

20 years

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10
Q

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

A

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

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11
Q

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

A

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.

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12
Q

When do generics become available for drugs?

A

After patent expires in 20 years

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13
Q

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

A

In Vitro Studies

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14
Q

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

A

1 billion

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15
Q

What is the CEDR?

A

FDA’s center for drug evaluation and research

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16
Q

When must and IND be submitted before?

A

before initiating human clinical trials.

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17
Q

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

A

IND

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18
Q

3 types of INDs

A
  1. investigator IND
  2. Emergency use IND
  3. Treatment IND
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19
Q

Info required to submit an IND

A
  1. Animal pharmacology and toxicology studies
  2. manufacturing information
  3. clinical protocols
  4. investigator information
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20
Q

Application that provides for review of a generic drug application

A

ANDA

21
Q

What is an ANDA

A

Abbreviated new drug application

22
Q

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

A

bioequivalence

23
Q

What act increased the patent length to 20 years?

A

1984 Drug Price Competition and Patent Term Restoration Act

24
Q

When do you usually apply for a patent?

A

When you apply for a NDA

25
Q

3 parts of Drug Nomenclature

A
  1. Chemical name
  2. Generic Name
  3. Trade Name
26
Q

manufacture or brand name is termed as the drugs _____.

A

trade name

27
Q

the common name of a drug

A

generic name

28
Q

5 members of the US adopted Names Council (USAN)

A
  1. AMA
  2. APHa
  3. USP
  4. FDA
  5. at large
29
Q

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

A

CEDR

30
Q

What is pharmacokinetics?

A

what the body does to a drug,

or how the drug moves/changes in the body

31
Q

5 parts to pharmacokinetics (LADME)

A
  1. Liberation
  2. Absorption
  3. Distribution
  4. Metabolism
  5. Elimination
32
Q

What is medical pharmacology?

A

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

33
Q

How can we excrete drugs?

A

through sweat, breast milk, urine, and feces

34
Q

The transformation of a drug molecule to something else

A

Metabolism

35
Q

what is pharmacodynamics?

A

What a drug does to the body

36
Q

What is pharmacotherapy?

A

How to treat disease and illness with medicine

37
Q

8 routes of drug administration

A
  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
38
Q

determines appropriate route and formulation of drugs

A

Pharmaceutics

39
Q

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

A

formulation, manufacture, stability, and effectiveness

40
Q

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

A

Pharmacogenomics

41
Q

3 types of metabolizers

A
  1. poor metabolizer
  2. extensive metabolizer
  3. ultra- extensive metabolizer
42
Q

Poor metabolizer

A

highest serum (drug)

43
Q

extensive metabolizer

A

“normal”/expected serum drug

44
Q

ultra-extensive metabolizer

A

lowest serum (drug)

45
Q

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

A

pharmacodynamics

46
Q

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

A

pharmacology

47
Q

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

A

NDA

48
Q

what best describes phase 1 of clinical trials?

A

main focus is on safety of the drug

MUSC Pharmacology (10 decks)

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