FDA regulation, trials, basic pharmacological terms

Question 1

Cp

Answer 1

plasma concentration. Cp vs time ~pharmokinetics.

Question 2

MEC

Answer 2

Minimum effective concentration.

Question 3

Time of onset

Answer 3

Time to reach MEC

Question 4

Duration of action

Answer 4

Time above MEC

Question 5

Therapeutic window or therapeutic index

Answer 5

Range between MEC and adverse response MEC

Question 6

Pharmacodynamics:

Answer 6

what the drug does to the body (pathophysiology)

Question 7

Pharmacokinetics:

Answer 7

how the drug moves through the body (pharmacology)

Question 8

What is bioavailability?

Answer 8

How much drug reaches the target organ.

Question 9

What is absorption?

Answer 9

Time from route of administration into blood.

Question 10

Distribution is:

Answer 10

rate of drug movement from the blood into the tissues.

Question 11

What is the difference between side effects and extension effects?

Answer 11

Side effects are reactions at a different site than target site. Extension effects are seen above the adverse reaction MEC at the target site (overdosage). Both are predictable based on mode of action of drug.

Question 12

What three huge processes does the FDA oversee?

Answer 12

Drug approval (trails)Generic equivalencyControlled substance classification and Rx/not

Question 13

What process does the state government oversee?

Answer 13

Who can prescribe (with the exception of controlled substances which is regulated by the DEA).

Question 14

What are relevant components of an animal trial?A human trial?

Answer 14

5-8 years, $30-60 million, safety, efficacy, try to establish dosage. 2-10 years. $100-200 million. 3 phases.

Question 15

Phase I trial

Answer 15

Small pool of healthy male volunteers (<100), establish safety, dosage

Question 16

Phase II trial

Answer 16

Larger pool of volunteers (200-300). Compare vs existing therapy or placebo.

Question 17

Phase III trial

Answer 17

Double blind study vs. placebo or existing treatment.

Question 18

What is phase IV? What is the purpose

Answer 18

Post-approval tracking. Physicians report low-incidence adverse responses. To find:1 in 100 incidence need 1800 patients1 in 1000 incidence need 18,000 patients1 in 10,000 incidence need 180,000 patients

Question 19

How do generic drugs compare to name brand? What differs?

Answer 19

They have exactly the same dosage, intended use, therapeutic effects, side effects, route of administration, risks, safety, and efficacy as the original drug.Most generic brands are bioequivalent. The mean bioavailability variation between brand and generic products tested in the United States since 1984 is less than 4%.

Question 20

What is bioequivalency?

Answer 20

Bioequivalent drug products have similiar bioavailability. The formulation is tested by the FDA to ensure equivalency.

Question 21

What is Therapeutic equivalency?

Answer 21

Same therapeutic effect between two drugs. Requires clinical testing in the same individual. Generally not tested by the FDA, under the assumption that bioequivalent drugs will also be therapeutically equivalent.

Question 22

What is the critical difference between a health claim and a structure function claim? Which requires FDA approval?

Answer 22

A health claim claims to cure a specific, named disease (eg osteoporosis). A structure/function claim claims describes the role of a substance intended to maintain the structure or function of the body (eg calcium may help strengthen bones). Health claims require FDA approval. Structure/function claims do not. [Any structure-function claims made on the label must contain this disclaimer:“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”]

Question 23

Schedule I:

Answer 23

High abuse potential, no currently accepted medical use; not for prescription use, but allowed for research and instructional use. [Consists of: 80-90 opiates / opium derivatives (heroin); ~30 hallucinogenic substances (LSD, MDMA-ecstasy, other designer drugs); mescaline, peyote, marijuana, psilocybin; ~10 depressants (methaqualone) and stimulants].

Question 24

Schedule II:

Answer 24

Accepted medical use, high abuse potential with severe liability to cause physical or psychological dependence. [Consists of: opioid analgesic drugs (morphine, codeine, oxycodone, hydrocodone  non-opioids, hydromorphone, meperidine, methadone); stimulants (methamphetamine, amphetamine, cocaine, methylphenidate); barbiturates (pentobarbital, secobarbital)].

Question 25

Schedule III:

Answer 25

Accepted medical use, moderate abuse potential and dependence liability (less than drugs in schedules I and II); abuse may lead to moderate or low physical dependence or high psychological dependence. [Includes opioids (codeine combined with non-opioids); stimulants (benzphetamine); depressants (glutethimide, certain barbiturates); anabolic steroids; cannabinoids].

Question 26

Schedule IV:

Answer 26

Accepted medical use, low potential for abuse leading to limited physical or psychological dependence relative to drugs in Schedule III. [Includes some depressants (chloral hydrate, phenobarbital, meprobamate); stimulants (phentermine); ~35 benzodiazepines (alprazolam, diazepam, chlordiazepoxide, lorazepam, triazolam); nonbenzodiazepine hypnotic agents (zolpidem, zaleplon, eszopiclone).

Question 27

Schedule V:

Answer 27

Accepted medical use, abuse potential even less than drugs in schedule IV. Can be obtained without prescription (OTC) in some states (with restrictions); treated like schedule III-IV in Colorado. [Contains opioids (diphenoxylate-antidiarrheal and codeine-antitussive) in low amounts].