lect 1 Flashcards
drugs
chem substance for tratment/diagnosis
biologic drugs
vaccine, protein, antibody (living things)
small molecule drugs
manufactured w/ chem syn and living things (aspirin)
ethical pharmaceutical company
discover molecular entities (large companies)
generic pharm. company
adapt/break patent
manuf and formulate methods
product is not protected from patents
go through ABBREVIATED NEW DRUG APPPLICATION–FDA for a new drug
biotech company
turn idea–> product
research intensive
less employees
sell fewer products
exist shortly
bought by bigger companies
contract research company
specialty services (biotesting, chem syn)
manuf. research, clinical trials
molecular entity
pure ingredient–ACTIVE INGREDIENT–acetaminophen
product
ingredients added to molecular entity
DIFF DOSES&FORMULATION
5 steps in making a drug
DDCFM
discovery
development
clinical trials
FDA APPROVAL
market
discovery
1-3 YRS
IDEA, DISCOVER NEW ME
DRUG CANDIDATE PRODUCED
Project initiation
disease markable
must make $ back
market analysis
customers
affordability
current treatment–cost, efficacy, safety, drug liek
competitive assessment then research analysis
other companies are..?
1st 3 drugs make most $
existing therapies
feasible study
disease solvable
existing drugs
patent issues
biochem studies
proof drug works
animal models
medicinal chem
identify active molecules
specificity
enter body
lead identification
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
rational drug test
design lead using chem structure
start w/sum known to make unknown
natural products
chem isolated from plants
secondary metabolites (poison)
hard to do SARS
academic labs
penicilin sp3 chiral
scarce
combinational chem
test compounds in mixture
identify molecules that have desire properties
de novo design
computer design
3d bio structure
lead optimization
DRUG CANDIDATE
SARS
parts of molecule interact w/bio target
molecules that enter body
Development
1-2 YRS
TURN DRUG CANDIDATE INTO A SELLABLE PRODUCT
documentation
mistakes
sued
FDA data
patent–novelty, utility, non-obvious
safety–>confirm activity
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
manufacture
large scale syn (heat and purification)
syn at lowest cost
formulation
INVESTIGATIONAL NEW DRUG
form of pill
excipient (other ingred in pill)
stabilizers
preservatives
fillers
disintergrants
binders
flavour/colour/lubricants
clinical trials
1-5 YRS
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
market
100 tonnes/year
safety testing
rare side effects
orphan drugs (pharm agent rare condition, >ME’s, short clinical trials, tax cred, gradually popular
FDA APPROVAL
6MTHS-1.5 YEARS
REMOVAL DATA FROM CT TO ENSURE TESTING DONE PROPERLY
DATA SHOWS BENEFIT > RISK
DC
IND
NDA
ANDA
- potential drug. secret structure
- permission to begin CT (animal trials prior), plan CT
- permission to enter market (efficacy, safety, dosing, drug labelling)
permission to market generic drug (drug identity, dose formulation, administration)
FDA & HEALTH CANADA
Safety testing done by companies
full data sent to FDA
Approval to market
inspection manufacture
report difficulties
