permits the use of an investigational drug in the tx of px not enrolled in the clinical study but who have a serious or IMMEDIATELY LIFE THREATENING disease for which there is no satisfactory alternative therapy

extracts water soluble and heat stable constituents from crude drugs by boiling in water for 15 minutes, cooling, straining and passing sufficient cold water through the drug to produce required volume

is where the active ingredients are extracted from a macerated drug mass in a narrow shaped vessel open at both ends through the passage of an extracting liquid called menstrum

is defined as a rare disease or condition that affects fewer than 200,000 people in the US

not likely to cause adverse health consequences

an agent intended for use in the diagnosis, treatment, mitigation, cure, and prevention of disease in man or animals the component which produces the pharmacological activity

do not contain oleaginous components completely water washable greaseless

defined by the FDA as an active ingredient that has never before been marketed in the US

semisolid preparations containing one or more medicinal agents dissolved or disoersed in either ow emulsion or wo emulsion or in another type of water washable base

is sometimes used in suspensions in aqueous vehicles intended for oral

means of administering drugs as formulated preparation •formulation which provide a therapeutic amount of drug to the proper site in the body promptly and maintain the desired drug concentration products that allow for the uniform release or targeting of the drugs into the body

is the process in which the solid ingredients are placed in a stoppered container with the whole of the solvent and allowed to stand for a period of at least three days. with frequent agitation.

are generally suspensions of solid materials in an aqueous vehicle

a prototype medical compound that has a fundamental desired biologic or pharmacologic activity

cause serious adverse effect or death

INACTIVE ingredient present in a dosage form vehicle, suspending agents, lubricants, binders

are semi solid preparations intended for application to the skin, and generally contain a larger proportion of solid material than ointments and therefore are stiffer

this is a form of maceration in which gentle heat is used during the process of extraction

FINISHED DOSAGE FORM that conatins the active ingredient, but NIT necessarilly, in association with one or more other ingredients

often used to describe suspensions of inorganic acids such as clay in water

sunsequent bioassay by biological experiment or technique carried out within a living organism

ow emulsions resembling creams easily washed from the skin water washable

a compound that requires metabolic biotransformation after administration to produce the desired pharmacologically active compound.

is a dilute solution of a readily soluble constituents of crude drugs for a short period of time which either cold or boiling water is added

The FDA provides support grants to conduct clinical trials on safety and effectiveness

formulation containing a specific quantity of active inredient/s in combination with one or more excipients. •provides mechanism for the safe and convenient delivery of drugs •concealment of offensive taste. •protection from destructive influence of the environment

dosage form without containing any medication

initial bioassay that takes place OUTSIDE the organism, in an artificial environment such as laboratory

are plastic masses containing 15% gelatin, 40% glycerin, 35% water, and 10% added medicinal substance

are semi solid systems consisting of dispersions of small or large molecules in an aqueous liquid vehicle rendered as jelly like by the addition of gelling agent

produces specifically the desired effect •administered by the most desired route (orally) •minimal dosage and dosage frequency •has optimal onset and duration of activity •easily produced at low cost

most famous surviving memorials of early drugs with more than 800 formulas or prescriptions

cause temporary or medically reversible adverse health consequences