Lecture 4 and 5 done

Question 1

Why are pharmaceuticals important?

Answer 1

commonly used, cost effective, variety of forms, complex, high demand

Question 2

What are the 7 basic functions of the FDA?

Answer 2

1)approval of drugs
2)regulation of labeling
3)drug advertising
4)manufacturing process
5)regulation of bioequivalence for generics and biosimiliars
6)monitoring of drugs for adversed reactions
7)monitor nations blood supply

Question 3

What is the FDA approval processs?

Answer 3

Discovery, preclinical testing, clinical trials, approval, postclinical testing

Question 4

Phase I clinical trial

Answer 4

how drug works, dosing, toxicities, small sample of health volunteers

Question 5

Phase II clinical trials

Answer 5

drug safety and effectivness, small sample of pattients with condition to be treated

Question 6

Phase III clinical trial

Answer 6

drug safety and effectivness via randomized controlled trials, large sample with condition to be treated, use of placebo

Question 7

Phase IV clinical trial

Answer 7

postmarketing survallence, monitor for adverse reactions

Question 8

Describe the generic frug approval process.

Answer 8

Abbreviated process because drug is already been proved to be safe and effective

Question 9

Describe small molecule drugs(generics).

Answer 9

small, chemically manufacture, easy and cheap to make, ‘traditional’ drugs, simple to replicate

Question 10

Describe biologics(biosimiliars)

Answer 10

large, comples molecules often made of proteins. Expensive and difficult to produce, nearly impossible to identically replicate

Question 11

True or false: interchangeable biological products can be substituted without prior authorization

Answer 11

true, but biosimiliars cannot

Question 12

What are issues with biosimiliars?

Answer 12

unclear role in treatment, confusing naming system, few currently exist

Question 13

WHat are some features of pharmaceutical marketing?

Answer 13

brand recognition, detailing, brand to consumer marketing