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20 Cards in this Set
- Front
- Back
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new chemical entity
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unknown clinical, toxicologic, physical and chemical properties
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preclinical stage
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animal pharmacology
toxicology data determine safety and efficacy |
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IND
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investigational new drug application
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phase 1
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clinical testing
healthy volunteers |
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phase 2
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lmt # of pt's w/ dz or condition
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phase 3
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multictr clinical studies side eff
large population |
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phase 4
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mftg scale up activities
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phase 5
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ok'd by fda -> prodt devlpmnt
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ANDA
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abbreviated new drug application
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specialty drug prodts
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existing prodts developedas a new delivery sys or for new therapeutic indication
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preformulation
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physical/chemical prop of active drug subs and dosage form
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dictate the drug prodt or drug delivery sys
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- therapeutic indication of drug
- route of admin |
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PAI
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preapproval inspections
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SUPAC
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scale up and post approval chgs
guidelines to dec # of maftg chgs that require preapproval by fda |
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CBE
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changes being effected
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GMP
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Good manftg practives
-min requirements that the industry must meet when mftg, processing, packing or holding human and veterinary drugs |
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qc
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establishing process and proct specification
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qa
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determines that the sys & facilities are adequately written proc are ff to ensure that finished drug prodt meets applicable quality specs
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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
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PRODUCT LINE EXTENSION CONTAIN THE NDA approved drug in an annual report
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-new dosage form
-new dosage strength - chgs after market approval in the formulation in that is a minor chg |
