Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

bps > lect 1 > Flashcards

lect 1 Flashcards

1
Q

drugs

A

chem substance for tratment/diagnosis

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

biologic drugs

A

vaccine, protein, antibody (living things)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

small molecule drugs

A

manufactured w/ chem syn and living things (aspirin)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

ethical pharmaceutical company

A

discover molecular entities (large companies)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

generic pharm. company

A

adapt/break patent
manuf and formulate methods
product is not protected from patents
go through ABBREVIATED NEW DRUG APPPLICATION–FDA for a new drug

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

biotech company

A

turn idea–> product
research intensive
less employees
sell fewer products
exist shortly
bought by bigger companies

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

contract research company

A

specialty services (biotesting, chem syn)
manuf. research, clinical trials

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

molecular entity

A

pure ingredient–ACTIVE INGREDIENT–acetaminophen

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

product

A

ingredients added to molecular entity
DIFF DOSES&FORMULATION

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

5 steps in making a drug

A

DDCFM
discovery
development
clinical trials
FDA APPROVAL
market

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

discovery
1-3 YRS

A

IDEA, DISCOVER NEW ME
DRUG CANDIDATE PRODUCED

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Project initiation

A

disease markable
must make $ back

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

market analysis

A

customers
affordability
current treatment–cost, efficacy, safety, drug liek

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

competitive assessment then research analysis

A

other companies are..?
1st 3 drugs make most $
existing therapies

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

feasible study

A

disease solvable
existing drugs
patent issues

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

biochem studies

A

proof drug works
animal models

17
Q

medicinal chem

A

identify active molecules
specificity
enter body

18
Q

lead identification

A

HTPS–random screening, tested with same dose, gain yes/no hits, good 500 hits, >hits fake b/c impurity and interference
retest hits using purified samples and ensure specificity
confirmation of structure–spectoscopy, no chiral centres

19
Q

rational drug test

A

design lead using chem structure
start w/sum known to make unknown

20
Q

natural products

A

chem isolated from plants
secondary metabolites (poison)
hard to do SARS
academic labs
penicilin sp3 chiral
scarce

21
Q

combinational chem

A

test compounds in mixture
identify molecules that have desire properties

22
Q

de novo design

A

computer design
3d bio structure

23
Q

lead optimization
DRUG CANDIDATE

A

SARS
parts of molecule interact w/bio target
molecules that enter body

24
Q

Development
1-2 YRS

A

TURN DRUG CANDIDATE INTO A SELLABLE PRODUCT

25
Q

documentation

A

mistakes
sued
FDA data
patent–novelty, utility, non-obvious

26
Q

safety–>confirm activity

A

in vitro (glass)–no carcinogens
in vivo (living syn)–small animal (primate and other specie)
Sulfanilamide—no testing on animal
Thalidomide—didn’t use right species before giving to children

27
Q

manufacture

A

large scale syn (heat and purification)
syn at lowest cost

28
Q

formulation
INVESTIGATIONAL NEW DRUG

A

form of pill
excipient (other ingred in pill)
stabilizers
preservatives
fillers
disintergrants
binders
flavour/colour/lubricants

29
Q

clinical trials
1-5 YRS

A

Nuremberg trials–voluntary, consent, animal studies, benefits > risk
phase 1–< 100 HEALTHY ppl, range & safety testing, 30% IND fail
phase 2 –200-300 ppl, PATIENTS efficacy, 70% IND fail
phase 3–1000s ppl PATIENTS, safety, efficacy, 70% fail
NEW DRUG APPLICATION

30
Q

market

A

100 tonnes/year
safety testing
rare side effects
orphan drugs (pharm agent rare condition, >ME’s, short clinical trials, tax cred, gradually popular

31
Q

FDA APPROVAL
6MTHS-1.5 YEARS

A

REMOVAL DATA FROM CT TO ENSURE TESTING DONE PROPERLY
DATA SHOWS BENEFIT > RISK

32
Q

DC
IND
NDA
ANDA

A
  1. potential drug. secret structure
  2. permission to begin CT (animal trials prior), plan CT
  3. permission to enter market (efficacy, safety, dosing, drug labelling)
    permission to market generic drug (drug identity, dose formulation, administration)
33
Q

FDA & HEALTH CANADA

A

Safety testing done by companies
full data sent to FDA
Approval to market
inspection manufacture
report difficulties

bps (6 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions