FDA reg prescription & OTC drugs checking safety & effectiveness.. FDA approval for drug can take 17.5 years. Begins with lab/animal studies. Preclinical trials, Investigational New Drug, Clinical Trials, New Drug Application, Phase IV. DEA concerned with illegal drugs or narcotics(controlled substances) Pharmacokinetics how you act upon the drug Dynamics: how drug affects ur body.
Chemical Name: specific chem struc, infrequently used(N-Acetyl-p-aminophenol) Generic: official or nonproprietary name. FDA. Derived from chemical name. Ibuprofen. Acetaminophen. All drugs hae generic name but not every drug avail in generic form. Trade: may or may not relate to other names. AKA brand; Tylenol(Acet) Motrin(ibu)
OTC: non prescrip, treat signs & symptoms, some once Rx, some both OTC&Rx. Prescription: treat/cure pathology. Medical supervision, physician perscribes, pharmacist dispense. Increase risk. Controlled sub: scheduled drugs based on inc abuse, dependence, and dec medicinal use. Restrictive controls.
Enteral oral: systemicdosage forms pills, syrups, capsules adv ez to adminster, cheap. Disadv: takes longer for effect, first pass effect( meds mainly go to liver to process and by the time it gets to area theres less dose, Enteral sublingual/buccal: under tongue in cheek. Lollipop film spray. Adv: dont affect liver, 1st pass effect no issue. Disad: certain molecules pass thru cheek. Enteral rectal: suppositorym ointment. Parenteral: dosage injections, suspensions. Adv: quickest to reach blood, no 1st pass. Inhalation: dosage powder, aerosol, adv: straight to lungs to diffuse into blood. Topical: dosage creams, patch, drops, stays local some are systemic.
PhKin phases, 1) Absorption: must be bioavailable(amount left in mg after stomach digest), affected by amount absorbed, rate of absorption. Distribution: systemic vs local, uneven distribution, chemical struc, tissue vascularity, local capillary struct. duration of action: period of time when concentration levels are sufficient enough to produce therapeutic effect. Metabolism: chemical alteration by enzyme. Substrates+enzymes= effects+metabolites, liver does action, metabolites water solube, inactive(left overs).Elimination: removal of drug metabolites. Urine, poo. Key organs: kidneys, sweat glands, lungs. half life is time it takes to reduce peak blood concentration by 50%. Have to take more if half life is 30 min