Drugs & Discovery

Question 1

Define drugs

Answer 1

• substance intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease
• recognized by pharmacopoeia
• intended to affect structure and function of body
• component, accesory, or part of device

Question 2

Define drug product

Answer 2

the finished dosage form that contains a drug substance

Question 3

Define dietary supplement

Answer 3

• product intended to supplement the diet that contains one or more of the following: vitamin, mineral, AA, molecule that increases daily uptake, concentrate, metabolite, constiuent, or extract of the previous
• not FDA regulated

Question 4

Define bioequivalence

Answer 4

• measurement of the rate or extent to which a therapeutically active chemical is absorbed from a drug product into the systemic circulation and becomes available at site of action
• how much of therapeutic drug is absorbed at site of action

Question 5

Identify differences between drug and drug product

Answer 5

Drug Product
-active and inactive parts – what is presented to the customer
Drug
-active part

Question 6

Identify differences between prescription and OTC drug

Answer 6

prescription
-requires drug prescription
OTC
-does not
-relatively safe

Question 7

Identify differences between dietary supplements and drugs

Answer 7

DS: not FDA regulated, not intended for treatment, diagnosis, cure, or mitigation of disease
D: FDA regulated

Question 8

Explain meaning of an “orphan drug”

Answer 8

• drug development for rarer diseases more beneficial for companies
• lower FDA fee charges and tax breaks

Question 9

Phase 1 of drug control

Answer 9

Discovery & Development

-new drugs discovered thru new insights (diseases), compound testing, unanticipated effects, new technologies

Question 10

Phase 2 of drug control

Answer 10

Pre-clinical

• initial screening of candidate drugs
• animal and toxicity testing
• GLP (?)
• goal: estimate risk of exposure to drug
• determine no-effect dose, minimal lethal dose, median lethal dose (LD50)
• drug screens in vivo and in vitro

Question 11

Phase 3 of drug control

Answer 11

Clinical Studies

• IND % (% investigational new drug) application – 30 days
• studies conducted in people
  
  • 20-100 healthy volunteers or people with condition for several months
  • then several hundred people with condition for several months to 2 years
  • 300-3,000 volunteers with disease for 1-4 years
  • several thousand volunteers with condition using multiple doses in a double blind study
  • now New Drug Investigation (NDA)

Question 12

Phase 4 of drug control

Answer 12

Post-Marketing Studies

• L/T safety
• cost
• dose improvement

Question 13

Compare and contrast the 3 types of INDs issued by the FDA

Answer 13

Type 1: Investigator IND
- unapproved drug, approved product for new use, or new dosage formulation
Type 2: Emergency Use IND
-experimental drug use in an emergency (sometimes termed compassion)
Type 3: Treatment IND
-final clinical studies before approval for a class of patients (vs. individual patients)
-can begin clinical trials before submitting NDA

Question 14

5 categories currently used by the FDA to stratify drug risk during pregnancy

Answer 14

• Category A: failed to demonstrate a risk to fetus in 1st trimester (and later) - many vitamins
• Category B: animal reproduction studies have failed to demonstrate a risk to fetus and there are no adequate and well-controlled studies in pregnant women (acetominophen)
• Category C: animal reproduction studies have shown adverse effect on fetus and no adequate and well-controlled studies in humans, but potential benefits may warrant use despite potential risks (most antibiotics)
• Category D: positive evidence of human fetal risk based on adverse reaction data from investigational or or marketing experience or studies in humans, but potential benefits may warrant use
• Category X: studies in humans or animals have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data in marketing or investigational experience, clearly outweighs potential benefits
• Category N: FDA has not classified the drug

Question 15

Identify 4 federal agencies with jurisdiction over drug manufacture, distribution, prescription, dispensing, and administration

Answer 15

• FDA - Food and Drug Administration
• FTC - Federal Trade Comission
• NRC - Nuclear Regulatory Comission
• DEA - Drug Enforcement Administration

Question 16

Describe the purpose for a “black box” warning

Answer 16

• highest level of FDA warning
• more likely to be taken off the market
• talks about side effects and possible risks

Question 17

How does vitamin D help with COVID?

Answer 17

• cofactor in many enzymes for metabolism

- increase ability to fight off infection

Question 18

Difference between branded and generic brands

Answer 18

Branded:
-proprietary, trade-marked name
-20 year patent protection
Generic:
-unprotected, cheaper
-have to go thru testing again to prove it is the same as original -- prove same bioequivalence

Question 19

Define no-effect dose

Answer 19

dose that has no measurable effect

Question 20

Define minimal lehal dose

Answer 20

lowest amount of substance that may cause death to specific test animal under defined set of conditions