Drug Development, Marketing, & Prescribing

Front 1

IND?

Back 1

Investigational New Drug

Notice of Claimed Investigational Exemption of a New Drug

Must be approved by FDA before clinical trials begin

Front 2

Does the FDA have the ability to block the testing of a new drug?

Back 2

yes, it can block it at the request for IND

Front 3

Phase 1 of clinical trials?

Back 3

• Pilot study in 20-80 healthy volunteers
• Determination of safety of several doses
• Determination of pharmacokinetic properties
• Non-blinded
• About 20% of tested drugs are approved

Front 4

Phase 2 clinical trials?

Back 4

• Studies in 100-200 patients with target disease
• Placebo and active drug controls
• Single-blind
• About 30% of tested drugs are approved

Front 5

Phase 3 clinical trials?

Back 5

• Studies in many (about 5000) patients with target disease
• Determination of efficacy for indication and side effects
• Usually double-blind and cross-over design with placebo or active control
• About 70% of tested drugs are approved

The only phase where the majority are approved

Front 6

What comes after phase 3?

Back 6

New Drug Application

Front 7

What is "the label?"

Back 7

• Approved by FDA as part of NDA process
• Same as package insert
• Available in The Physician’s Desk Reference
• Contains chemistry, pk, indication, side effects, toxicity, contraindications, dosage, information in special populations
• NOT a critical guide; doesn't compare it to other drugs on market

Front 8

Phase 4?

Back 8

Post-marketing surveillance

Front 9

Can you ship a drug for an indication other than it's "label?"

Can you prescribe one?

Back 9

-can't ship one

-CAN prescribe one to individual pt

Front 10

Generic manufacturer must prove bioequivalence of generic formulation within ______% of the proprietary formulation

Back 10

+/- 20%

Front 11

Treatment IND (1987) = Promising investigational drugs in what phase can be available for patients with life-threatening conditions or serious chronic conditions?

Back 11

late Phase II or III

Front 12

Regulatory authority of prescriptions?

Back 12

state boards

Front 13

Schedule 1 drug definition?

Back 13

high abuse potential

Unsafe

research only

no accepted medical use

Front 14

Examples of schedule 1 drugs

Back 14

heroin

Marijuana (but not really)

Front 15

Schedule 2 drug definition

Back 15

severe physical/psychological dependence

WRITTEN prescription required

no refills

Front 16

examples of schedule 2 drug?

Back 16

morphine

amphetamine

Front 17

schedule 3 drug definition?

Back 17

moderate-to-low physical dependence

high psychological dependence

written or oral prescriptions - no more than 5 refills

Front 18

Examples of schedule 3 drug?

Back 18

Codeine

Front 19

Schedule 4 drug definition? Examples?

Back 19

Same as schedule 3 but penalties for illegal possession are different

benzodiazepines

Front 20

Schedule 5? examples?

Back 20

over the counter stuff

antitussives with low codeine