11. IND=End of animal testing
NDA=end of clinical phase
clinical testing : safety, pharmokinetic ? Does it work? even blinded?
vitro studies= 2 yrs
Animal studies= is a MES ... Efficacy, selectivity , mechanism
16. •
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Type A = affect Any individual and types A have the well known
affects and 85-90% of bad reactions belong to type A
Type B are heypersensitive , susceptible groups; symptoms are different ,
not predictable