Exam 2 PPT Slides - Supply Chain

Drug: “Substances that produce a change in cellular or physiological functioning of humans.”

For Drugs... End-point of the supply chain drives demand

The five factors influencing prescribing behavior are:

What are the two main acts used by the FDA to control pharmaceuticals?

Non-FDA-approved (“off-label”) indications are uses of a product that were not approved by the FDA, but have shown value after approval based on postmarketing research.

Non-FDA-approved indications can be promoted by the manufacturer.

The FDA started allowing direct advertising in what year?

Drug prices: Suggested price determined by manufacturer is usually a different price (much lower) that is actually paid out-of-pocket by most consumers based on their insurance plan.

This phase in the drug development is tested on non-human subject

Which of the phases allow human trail?

Phase 1 trials allow 20-80 people (for safety, dosing range, and side effects). Phase 2 trials allow 100-300 people (for effective and further evaluation of safety). Phase 3 trials allow how many people (to confirm effectiveness, monitor side effects, and compared it to commonly used treatments)?

Phase 4 trial - post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.