Clinical Trials & Toxicology

Question 1

The pharmacological result, either desirable or undesirable, of drugs interacting with themselves or with other substances
OTC drugs, foods, herbal and ‘nutritional’ supplements are potential sources

Answer 1

Drug interactions

Question 2

Describes drug interactions when both of the interacting drugs have similar action

Answer 2

Homergic

Question 3

Describes drug interactions when only one of the drugs is active in the behavioral measure employed; other lacks the effect

Answer 3

Heterergic

Question 4

Drug interaction type where the drugs are chemically incompatible

Answer 4

Physiochemical

Question 5

Drug interaction type where absorption, distribution, biotransformation or elimination is altered for one or both drugs

Answer 5

Pharmacokinetic

Question 6

Drug interaction type that is typically used for drugs interacting at the same site or mechanisms

Answer 6

Pharmacodynamic

Question 7

3 types of drug interaction types in order

Answer 7

Physiochemical
Pharmacokinetic
Pharmacodynamic

Question 8

Term that describes:
Effective in 50% of test population
Produces half the maximal response

Answer 8

Effective dose 50 (ED50)

Question 9

Term that describes:
Lethal in 50% of test population
Produces half the lethal response

Answer 9

Lethal dose 50 (LD50)

Question 10

Term that describes:
Toxic in 50% of test population
Produces half the toxic response

Answer 10

Toxic dose 50 (TD50)

Question 11

Equation for therapeutic index (TI) aka therapeutic window

Answer 11

TI = TD50 / ED50

Question 12

Are large or small values of therapeutic index (TI = TD50 / ED50) good?

Answer 12

Large
Takes a lot more drug to make people sick than it does to make them well

Question 13

Equation for certain safety factor (CSF) aka margin of safety

Answer 13

CSF = TD1 / ED99

Question 14

Which is typically a better measure of safety, therapeutic index (TI) or certain safety factor (CSF)?

Answer 14

Certain safety factor (CSF)
CSF = TD1 / ED99
TI = TD50 / ED50

Question 15

Are large or small values of Certain safety factor (CSF = TD1 / ED99) good?

Answer 15

Large

Question 16

Toxicology term:
Heritable change in genetic material
Limited to effects on nucleic acids

Answer 16

Mutagenesis

Question 17

Toxicology term:
Change in genetic material resulting cancer

Answer 17

Carcinogenesis

Question 18

Toxicology term:
Changes in genetic material resulting in congenital malformations that are grossly visible at birth
Typically related to drug-related change in first trimester

Answer 18

Teratogenesis

Question 19

What is meant by: Cell injury or death during the first two weeks of pregnancy may not be teratogenic (all or nothing)

Answer 19

Fetus killed, OR
Damaged cells replaced by undifferentiated cells without long-lasting consequences

Question 20

Vulnerability to a specific drug’s teratogenic effect may be greatest during specific periods of development, specifically:

Answer 20

Highly vulnerable from weeks 3-8

Question 21

Can men have teratogenic risk?

Answer 21

Yes (e.g. systemic retinoids)

Question 22

Can teratogenic risk persist long after drug administration?

Answer 22

Yes (e.g. systemic retinoids)

Question 23

This type of drug application may be better when nursing infants as lower systemic levels generally occur

Answer 23

topical

Question 24

Law that required proof of safety and effectiveness
Explanation: Dr. Kelsey of USD did not approve thalidomide due to it being unsafe

Answer 24

Harris-Kefauver Amendment of 1962

Question 25

Administration that enforces drug laws

Answer 25

Drug Enforcement Administration (DEA)

Question 26

Phase of FDA approval of a new drug:
Includes animal testing
Acute, subacute, chronic and reproductive toxicity evaluation
Requires multiple species
Basic pharmacokinetic profile established
Basic pharmacodynamic profile established
Includes extensive in vitro testing

Answer 26

Preclinical phase

Question 27

Phase of clinical phase during FDA approval of a new drug:
Determines effects, safety, dosage and pharmacokinetics
Healthy volunteers

Answer 27

Phase I

Question 28

Phase of clinical phase during FDA approval of a new drug:
Is it safe and effective?
Small number of patients with the disorder

Answer 28

Phase II

Question 29

Phase of clinical phase during FDA approval of a new drug:
Is it safe and effective when used in a larger more diverse patient population?

Answer 29

Phase III

Question 30

Phase of clinical phase during FDA approval of a new drug:
Postmarketing surveillance, aka pharmacovigilance
Monitor problems that occur after NDA approval and report to manufacturer or FDA
Primary focus on adverse effects, compliance, and drug interactions

Answer 30

Phase IV

Question 31

Class of controlled substances:
The controlled substances in this schedule are those that have no accepted medical use in the US, are not accepted as safe for use under medical supervision, and have a high abuse potential
Ex: Heroin, lysergic diethylamide (LSD), marijuana, peyote, methaqualone and certain fentanyl and meperidine analogs

Answer 31

Schedule I (CI)

Question 32

Class of controlled substances:
Have high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the US
Ex: morphine, phencyclidine, methadone, cocaine, methamphetamine
Special prescribing concerns

Answer 32

Schedule II (CII)

Question 33

Class of controlled substances:
Have abuse potential and dependence liability less than those in previous schedules, and have accepted medical use in the US
Ex: anabolic steroids, codeine and hydrocodone with aspirin or acetaminophen, some barbiturates

Answer 33

Schedule III (CIII)

Question 34

Class of controlled substances:
Have abuse potential and dependence liability less than those listed in the previous schedule and have an accepted medical use in the US
Ex: Diazepam and pentazocine

Answer 34

Schedule IV (CIV)

Question 35

Class of controlled substances:
Have abuse potential and dependence liability less than those listed in previous schedule and have an accepted medical use in the US
Ex: cough medications with codeine, antidiarrheal containing low doses of opiates, and some analgesics

Answer 35

Schedule V (CV)

Question 36

Federal regulation under the authority of the ______ determines what is a prescription drug and what is not

Answer 36

FDA

Question 37

Means of conveying treatment intentions to the patient, pharmacist or other health care professionals
Represents the end of a diagnostic process

Answer 37

Prescription