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ch 1and 2 ceutics

kira's notes

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