Drug Names Chemical name- describes its molecular structure and distinguishes it from other drugs
Generic name- is determined by the pharmaceutical company along with the a special organization known as the U.S. Adopted names Council
Trade names or brand name- the manufacturer selects alone…can become a registered trademark. They are they only one who can advertise and market the drug under that name.
The particular spelling of a brand name drug is proposed by a manufacture for one of several reasons.
To indicate the disease process being treated Azmacort- treats asthma Rythmol- treats cardiac arrhythmias
To simplify the generic name Pseudoephedrine to Sudefed Haloperidol to Haldol Ciprofloxacin to Cipro
To indicate the duration Slow-K slow release potassium supplement
Drug Design New drugs are discovered in one of two ways Totally new chemical substance Derived from molecular manipulation of a current drug
Drug Design Until recently,designing a new drug by changing the molecular structure of an existing drug was a very slow process of trial and error
Recombinant DNA technology Gene splicing or genetic engineering Aided by computer design and use of enzymes, researchers are able to remove DNA chemically from one organism and transplant into other
Testing In vitro- in glass In vivo- in living many guidelines set by FDA
Animal Phase Precedes human testing watching for toxic effects,side effects, addictions, cancerous tumors or fetal deformities
Animal Phase Calculating the Therapeutic Index (TI)…. The difference between the dosage that produces a Therapeutic Effect and the dosage that produces a Toxic Effect
Animal Phase NOT always a reliable indicator of how well a drug will perform in humans.
Human Testing 3 phases 1st phase- Healthy volunteers used to study a safe dose range, evaluate side effects and establish a correct dosage. Absorption
Phase II Drug is given on an experimental basis to patients with the disease it will eventually be used to treat- done to determine the extent of its therapeutic effect
Phase III Drug is administered to several hundreds of ill patients in exactly the way in which it will be used clinically (dosage & route) compared to other current drugs
Phase III Human Group A all patients disorder and receive new drug being studied results compared to next two groups for side effects and ability to treat disorder
Phase III Human Group B all patients have disorder meant to be treated by new drug all patients receive a placebo and results are compared to other 2 groups
Phase III Human Group C all patients have disorder meant to be treated by new drug patients will be treated by another drug currently being used to treat disorder
FDA Approval After reviewing all documentation on the safety and effectiveness of the new drug May be protected by a patent for up to 17 years