Exam 1

Question 1

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

Answer 1

drug

Question 2

What is the definition of a drug?

Answer 2

A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease

Question 3

What determines and regulates the drug approval process, language used on the label and on ads, enforces Public Health Service Act, and enforces the Federal Food, drug, and cosmetic act?

Answer 3

Food and Drug Administration (FDA)

Question 4

What is the primary focus of the FDA?

Answer 4

Enforce the Federal Food, Drug and Cosmetic Act

Question 5

Is drug regulation the same now as it was in the 80s?

Answer 5

No, drug laws are constantly changing and have not always been that way. Laws have evolved greatly and its because of the FDA

Question 6

What are the four categories of drug development?

Answer 6

In vitro studies, animal testing, clinical testing and marketing

Question 7

At this time, chemists and drug manufactures are thinking about what drug they want to develop, and editing compounds that they think they might want to be a drug

Answer 7

In vitro studies

Question 8

Biological products and chemical synthesis of an optimal new drug is called the

Answer 8

lead compound

Question 9

About how long does it take for chemists to come up with a drug to take to animal testing?

Answer 9

2 years

Question 10

What. is the next stage after in vitro studies?

Answer 10

Animal testing

Question 11

During the animal testing stage, what are the manufactures checking with the new drug?

Answer 11

Efficacy, selectivity, and mechanism–They want to make sure the drug is safe and see if it even helps whatever we are testing

Question 12

From animal trials onwards, what are we always testing?

Answer 12

Safety assessment and drug metabolism

Question 13

After about 2 years of successful animal trials, what must be done to move on to clinical testing?

Answer 13

Apply for an IND (Investigational New Drug) from the FDA

Question 14

What is the first process in a chemical becoming a drug as far as the FDA is concerned?

Answer 14

IND

Question 15

What are the phases of clinical testing

Answer 15

Phase 1, Phase 2, Phase 3

Question 16

During clinical testing, this phase has about 20-100 subjects and is testing safety of the drug

Answer 16

Phase 1

Question 17

During this clinical phase, the number of participants has increased to about 100-200 and it is testing safety and seeing if it actually works

Answer 17

Phase 2

Question 18

This phase enrolls about 20-100 healthy people, usually college kids, typically without illness to make sure the drug is safe

Answer 18

Phase 1

Question 19

What is the purpose of adding more people during each phase of clinical trials?

Answer 19

As you add more people, odds are if an adverse reaction is going to happen, it would more likely present itself in a larger number of enrollees

Question 20

As clinicians, which phase do we typically start to hear about a drug?

Answer 20

Phase 3

Question 21

What is the last stage of clinical trials before going to market?

Answer 21

phase 3

Question 22

In this phase, number of participants is increased to 1000-6000 people, and double blind experiments are implemented, still concerned to see if the drug is actually working and if it is safe

Answer 22

Phase 3

Question 23

What must a drug company apply for after successfully completing all three phases before going to market?

Answer 23

NDA (New drug application), usually happens after about 8-9 years after the drug was created within in vitro studies

Question 24

Who approves the NDA before a drug goes to market?

Answer 24

FDA- reviews all clinical trials and approves marketing scheme; the drug companies have invested about 1 billion dollars at this point

Question 25

What is phase 4 during drug development?

Answer 25

Marketing and postmarking surveillance

Question 26

As a clinician, which phase are you required to report any adverse side affects of a drug you prescribed to the FDA?

Answer 26

Phase 4

Question 27

How are drugs that have been on the market recalled after years?

Answer 27

Phase 4 post marketing surveillance, still monitoring safety forever

Question 28

When does phase 4 end?

Answer 28

There is no end to phase 4, safety monitored forever

Question 29

How do drug companies protect their product, having exclusive rights to what they have created?

Answer 29

Patents

Question 30

How long do patents last and what happens when the patent period runs out?

Answer 30

Patents generally last about 20 years after filing. Drug companies typically apply for a patent right before the IND phase because people have to know the chemical makeup during that phase. So if it take 10 years to complete clinical phase, drug companies only have about 10 years to recuperate all their investment. After the 20 years, the drug can be made by any company as a generic

Question 31

Can drug companies reapply for another patent once their time is up?

Answer 31

No, they can try to extend

Question 32

What is FDA's center of drug evaluation and research?

Answer 32

CEDR

Question 33

What ensures drugs (both Rx and OTC) for use in humans to be marketed are safe and effective?

Answer 33

CEDR

Question 34

Some drugs that start as prescription eventually are deemed safe enough to see to public without provider, who makes this change?

Answer 34

CEDR

Question 35

Must be submitted before initiating human clinical trials, and provides exemption to federal law to allow transport across state lines for clinical trials

Answer 35

IND

Question 36

What all is an IND required for?

Answer 36

new indication, change in companies promotion, change in approved population or risk to population, change in approved route of administration or dosage

Question 37

What are the three types of IND?

Answer 37

Investigator, emergency use, and treatment

Question 38

This type of IND is used to initiate/conduct investigation

Answer 38

Investigator IND

Question 39

This type of IND authorizes use in emergency situations

Answer 39

Emergency IND

Question 40

This type of IND is for the use of drug showing promise in clinical testing for serious or life threatening conditions while final clinical trials are conducted

Answer 40

Treatment IND

Question 41

What information is required when applying for an IND?

Answer 41

animal pharmacology and toxicology studies, manufacturing/chemical information, and clinical protocols and investigator information

Question 42

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

Answer 42

NDA

Question 43

What information does FDA review to reach the decision about an NDA?

Answer 43

- Drug is safe and effective in its proposed use - whether benefits outweigh the risks - proposed labeling is appropriate and what it contains - methods used in manufacturing maintain the drug's quality and preserve the drug's strength, identity, and purity

Question 44

Is it possible for a drug to be 100% safe?

Answer 44

No! There are zero drugs on the market that are 100% safe, wee always have to weigh benefits with the risks

Question 45

What is an ANDA?

Answer 45

Abbreviated new drug application

Question 46

This provides for the review of a generic drug product and is done after the patent of a drug runs out

Answer 46

ANDA

Question 47

What is the main focus a generic brand medication must demonstrate?

Answer 47

Bioequivalence- same chemical and same profile once in the body

Question 48

Do generic drugs have to go through human trials?

Answer 48

No

Question 49

Generic drugs must be comparable tot the innovator drug in what ways

Answer 49

- dosage form (if original is tablet, it must also be) - strength - route of administration - quality - performance characteristics - intended use

Question 50

Why is it a faster process to make a generic form of a drug?

Answer 50

It is an "abbreviated" process because generally not required to provide preclinical and clinical date to establish safety and effectiveness

Question 51

What was the start of modern pharmaceutical market and extended the patent period and tied it to the length of the approval process

Answer 51

1984 Drug Price Competition and Patent Term Restoration Act

Question 52

Which phases are open label types of trials?

Answer 52

Phase 1 and Phase 4

Question 53

Which phase looks at efficacy, safety and dose ranging?

Answer 53

Phase 2

Question 54

Describes the chemical and molecular structure (Ex: N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine)

Answer 54

Chemical name

Question 55

Common name of a drug

Answer 55

generic name

Question 56

Brand name of a drug

Answer 56

trade name

Question 57

As a clinician, what drug name is important to know?

Answer 57

Generic and trade, but the most important is the generic name

Question 58

Who comes up the the generic name?

Answer 58

US Adopted Naming Council (USAN)

Question 59

Serves health professions of the United States by selecting simple, informative and unique nonproprietary names for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships

Answer 59

USAN

Question 60

The discovering, chemistry, composition, identification, bio-physical effects, uses and manufacture of drugs

Answer 60

Pharmacology

Question 61

study of substances that interact with living systems through chemical processes (Activate to inhibit normal body processes)

Answer 61

Pharmacology

Question 62

the science of substances used to prevent and treat disease

Answer 62

medical pharmacology

Question 63

a branch of pharmacology that deals with poisons or drugs causing them

Answer 63

toxicology

Question 64

What the BODY does to a DRUG, how the drug MOVES?CHANGES in the body

Answer 64

Pharmacokinetics

Question 65

Relationship of adjustable elements (dose, form, frequency, route) to drug concentration

Answer 65

time profile in pharmacokinetics

Question 66

What does LADME stand for in pharmacokinetics?

Answer 66

Liberation (drug release) Absorption (drug enters circulation) Distribution (drug movement thru body "compartments") Metabolism (transformation of patent compound) Elimination (drug removal from body)

Question 67

What the DRUG does to the BODY

Answer 67

Phamacodynamics

Question 68

Relationship of the drug concentration at site of action and magnitude of effect produced

Answer 68

Pharmacodynamics

Question 69

This type of Pharm includes physiologic effects of drugs (on the body, microorganisms, parasites, drug targets) and drug behavior at the site of effect

Answer 69

Pharmacodynamics

Question 70

The use of medicine in disease, evidence based medicine (1o, 2o, 3o literature, clinical trials), clinical guidelines and off-label uses

Answer 70

pharmacotherapy

Question 71

Variation in drug response due to variation in genes, includes drug receptors, targets, and transporters

Answer 71

pharmacogenomics

Question 72

what is most effected in pharmacogenomics?

Answer 72

metabolism

Question 73

this type of metabolizer has the highest serum drug concentration

Answer 73

Poor metabolizer

Question 74

this type of metabolizer has a "normal" or expected serum drug concentration

Answer 74

Extensive metabolizer

Question 75

this type of metabolizer has the lowest serum drug concentration

Answer 75

Ultra-extensive metabolizer

Question 76

What other properties are affected in pharmacogenomics?

Answer 76

Absorption, distribution, efficacy, and toxicity

Question 77

formulation, manufacture, stability, and effectiveness of pharmaceutical dosage forms

Answer 77

phamaceutics

Question 78

What branch of Pharm determines the appropriate route and formulation

Answer 78

pharmaceutics

Question 79

Metabolism is a ____ property

Answer 79

pharmacokinetic

Question 80

Drug interaction with a receptor is best describes as?

Answer 80

pharmacodynamics

Question 81

What must be filed prior to human clinical trials?

Answer 81

IND