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20 Cards in this Set

  • Front
  • Back
new chemical entity
unknown clinical, toxicologic, physical and chemical properties
preclinical stage
animal pharmacology
toxicology data
determine safety and efficacy
investigational new drug application
phase 1
clinical testing
healthy volunteers
phase 2
lmt # of pt's w/ dz or condition
phase 3
multictr clinical studies side eff
large population
phase 4
mftg scale up activities
phase 5
ok'd by fda -> prodt devlpmnt
abbreviated new drug application
specialty drug prodts
existing prodts developedas a new delivery sys or for new therapeutic indication
physical/chemical prop of active drug subs and dosage form
dictate the drug prodt or drug delivery sys
- therapeutic indication of drug
- route of admin
preapproval inspections
scale up and post approval chgs

guidelines to dec # of maftg chgs that require preapproval by fda
changes being effected
Good manftg practives

-min requirements that the industry must meet when mftg, processing, packing or holding human and veterinary drugs
establishing process and proct specification
determines that the sys & facilities are adequately written proc are ff to ensure that finished drug prodt meets applicable quality specs
preclinical animal toxicity studies
clinical effecacy studies
human safety & tolerance
required info contained in a new drug application that is NOT incl in the ANDA
PRODUCT LINE EXTENSION CONTAIN THE NDA approved drug in an annual report
-new dosage form
-new dosage strength
- chgs after market approval in the formulation in that is a minor chg