Stack #100815
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| a drug substance is also called a | API active pharmaceutical ingredient that produces pharmacological activity
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| a new chemical NCE is a drug substance with | unknown clinical, toxicological physical and chemical properties. it is a API that has not been approved for marketing in the US
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| what stage or phase is a IND or investigational new drug application for human testing submitted to the FDA | preclinical stage
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| testing on animals to determin safety and efficacy | preclinical stage
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| after IND application is submitted where testing is done on health humans to determine tolerance and toxicity | phase one
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| less than 100 patients with condition | phase two
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| which phase is the drug formulation developed | phase two
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| large scale human studies | phase three
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| when is the NDA submitted to FDA | after clinical trials I-III
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| what is NDA | new drug application
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| what phase is after NDA submission but before approval to market often referred to as scale-up activities | phase IV
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| what does SUPAC stand for | scale up and post approval change
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| during phase five what can go on | product line extension new phsical form or strength changes but no use or indication changes
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| what does bioequivalent meen | have the same rate and extent of drug absorption
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| a generic must be the same in what 4 things | therapeutically eqv, same amount of drug, dosage form, and bioequivalent
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| what is a ANDA | abbreviated new drug application generic drug approval
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| what is general required instead of clinical trials | human bioequivalence studies (not preclinical or clinial toxcity or human safety studies)
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| ___is application for human testing:___is application for approval to market after clinical trials:___application for generica approval | IND, NDA, ANDA
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| manufacturer ensures finished dosage form has met all specification for inteneded use | ouality control
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| acceptance or rejection of incoming raw materials | quality control
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| system of facilities are aedquate and that written procedures are followed | quality assurance
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| coarse>colloidal >true | know the order
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| what three properties do colloids exhibit | tyndall, brownian movement, and electophoresis
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| sucrose, urea, gycerin and naphthalene are nonelectrolytes or electrolytes | nonelectroytes
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| HCl, sodium sulfate, ephedrine, phenobarbital | electrolytes
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| buffers are combinations of | weak acid and conjugate base (salt) or weak base and conjugate acid
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| henderson hasselbalch | ph=pka + log (salt/acid)
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| hermetic container | AIR TIGHT impervious to air or any other gas
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| there are glass types 1-3 that intended for parenteral products with __being the most resistant of leaching alkali from glass | type one
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| two problems with plastics | permeablity(dissoles plastic) and leaching(components of container enter content)
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| problem in plastic where binding of molecule to polymer materials | sorption
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| in vitro | lab setting
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| invivo | where you test bioavailablity in the systemic circulation of humans after its administration
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| preformulation studies define | the nature of the drug substance and framework for the drug's combination with pharmaceutical ingredients in fabrication of a dosage form
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| crystalline form vs amorphous in melting point | crystalline has orderly arranged units an show definited meling point
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| amyl nitrite | liquid that is volatile and flammable break glass and inhale
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| liquids cannot be formulatied in tablet form except | for nitroglycerine and scopolamine that is a solid salt form
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| increase solubility by | put into salt form, cosolvent complexation, micronization, solid dispersion
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| dissolution rate is usualy the rate limiting step | anything that will affect dissolution rate will also affect absorption
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| you can increase dessolution by | increasing solubility or decreasing size (ph is not an effective means of improving solubility
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