Bps 2110 Midterm #1 Updated Questions And Correct Answers

BPS 2110 MIDTERM #1 UPDATED QUESTIONS AND
CORRECT ANSWERS
Question:
1. Biologic Drugs (key characteristics)
Answer:
- manufactured using liv-
ing things (plants, an-imals, humans, single cells)
- normally high molecular
weight (>2000)

Question:
2. What are the most commonly known biologic drugs?
Answer:
vaccines, proteins, anti-bodies, nucleic acids

Question:
3. Small molecule drugs (key characteristics)
Answer:
- manufactured using liv-
ing things or chemical synthesis
- normally low molecular
weight (<2000)

Question:
4. What are the 4 main kinds of pharmaceutical compa-nies? (indicate which two are the largest)
Answer:
Ethical companies (very large), generic compa-nies (very large to medi-um), biotech (small),
con-tract research organiza-tions (CRO) (small to medium)

Question:
5. Ethical Pharmaceutical Companies
Answer:
- high research invest-
ments
- discover and develop
new molecular entities
- very large (100,000s of
employees)

Question:
6. Generic Pharmaceutical Companies
Answer:
- research is limited, fo-
cused on manufacturing if anything
- not looking for new
- market products no

,longer protected by patents
- very large to medium
(100,000s employees)

Question:
7. Biotech Companies
Answer:
- small (10-1000s)
- sell few specialty prod-
ucts
- heavily research inten-
sive
- created to exploit acade-
mic discoveries
- exist to be bought out

Question:
8. Contract Research Organizations
Answer:
- low risk
- provides specialty SER-
VICES for the pharma-ceutical industry (testing, manufacturing, trials, syn-thesis, etc)
- small to medium
(100s-10,000s)

Question:
9. Molecular entities vs drug products
Answer:
ME: active chemical sub-stances used in pharma-ceuticals, produce the ef-fects of the product DP:
different forms/com-bos of MEs in the fi-nal form administered to the patient, more com-mon since it
can be sold in different doses, formu-lations or combos

Question:
10. The 5 major phases of discovering a new drug
Answer:
Discovery, Development, Clinical Trials, FDA ap-proval, Market

Question:
11. Discovery phase (key characteristics: time, goals, end product)
Answer:
- 1 to 3yrs
- start with an idea and
discover a new molecular entity
- drug candidate

Question:
12. Development phase (key characteristics: time, goals, end product)

, Answer:
- 1 to 2yrs
- turn drug candidate into
sellable product
- investigational new drug

Question:
13. Clinical trial phase (key characteristics: time, goals, end product)
Answer:
- 1 to 5yrs
- test IND for safety -- es-
tablish safe limits for dos-ing, test for efficacy, estab-lish dosing, test for rare side effects
- New Drug Application

Question:
14. FDA approval phase (key characteristics: time, goals, end product)
Answer:
- 6mo-1.5yrs
- review data from clinical
trials to ensure testing was done properly, verify that data shows clear benefit which outweighs risks
- market approval

Question:
15. Market phase (key characteristics: time, goals, end product)
Answer:
- unlimited
- make money, continue
safety testing, identify very rare side effects, find new indications
- $$$

Question:
16. What are the key characteristics (goals, # of patients, types of patients, avg time, drug failure rate)
of the three phases of clinical trials?
Answer:
Phase I:
- safety, find max safe
dose
- ~ 100 patients
- healthy volunteers
- <1yr
- 30%
Phase II:
- safety, efficacy, find ef-
fective dose
- 200-300
- patients
- ~1yr
- 70%