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ch 1and 2 ceutics
kira's notes
| Question | Answer |
|---|---|
| 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 |