kira's notes
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| A drug product approved or unapproved by the FDA that produces pharmacological activity | API (active pharmaceutical ingredient)
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| drug with unknown clinical, toxociological, physical, and chemical properties that is unapproved by the FDA | NCE NEW Chemical Entity
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| what drug development phase test on animals for efficacy | preclinical
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| what drug development phase clinical testing on human volunteers for safety only | phase one
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| what drug development phase tests on small batch of patients | phase two
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| what drug development phase does large scale studies on patients with controls | phase three
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| what application is submitted between preclinical and Phase one | IND investigational New Drug
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| what application is submitted after phas 3 of clinical trials-if accepted, drug can be marketed | NDA New Drug Application
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| what is used to extend the patent life and can change the dosage form or strength, not the indication | product line extention (after drug is already on the market)
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| drugs that are marketed under trade name by the pharmaceutical man. | Brand Named Drugs
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| Drugs that are made with same active ingredient and dosage form after patent expires | Generic drugs
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| what four things must be the same when producing a generic drug | therapeutically equivalent, contain same amount of drug, be the same dosage form, and be bioequivalent
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| what does bioequivalent mean | same rate and extent of absorption
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| generic tablets must be the same as there band counter part in all but what 4 things | they may differ in size, color, shape and excipients
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| what application must a manufactor fill out in order to produce a generic drug | and ANDA
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| what two studies must be performed in order for a manufactoring company to produce a generic drug | biequivilance and human toxicology studies only
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| QC or QA ensures the quality of the drug and contents | QC
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| QC or QA controls what is going into your body | QC
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| QC or QA ensures quality of the process and manufacturing site | QA
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| QC or QA ensures that the plant and process are up to par | QA
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| which of the following has greater particle size true solution, colloidal dispersion, or coarse dispersion | coarse dispersion>colloidal>true solution
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| what three properties do colloids exhibit | tyndall, brownian movement, electrophoresis
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| ____is random movement of particles while____ is scattering of light beam and reflection off of particles | brownian movement, tyndall effect
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| uncharged solutes that do not conduct electical current | nonelectrolytes
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| which of the following is not an example of a nonelectrolyte ephedrine, urea, glycerin, sucrose and naphthalene | ephedrine is an electrolyte
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| _have regular colligative properties while ____ do not exhibit colligative propertices | nonelectroytes do electrolyes don't
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| ephedrine and phenobarbital are | electrolytes and not exhibit colligative properties
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| the sum of properties of constituents in solution are ____ properties | additive properties
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| ____properties depend on mode of linkage of the atoms in the molecule | constitutive properties
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| optical rotation is a example of what kind of property | constitutive property
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| which property depends on number of ions dissociated, not mass of ions | colligative properties
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| melting point and freezing point are examples of ____ properties | colligative
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| which properties depend on molecular weight-sum of the masses of constituent atoms | additive properties
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| buffers are compounds that resist changes in pH upon addition of ___ and is usually a combination of ___ and ____ | acid combo of weak acid and conj base or weak base and conj acid
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| the ability of a buffer to resist changes in pH is know as | buffering capacity
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| when buffering capacity is at its best, the ph of a solution should change | very little
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