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Stack #100815

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

 



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