Drug design and testing,

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 it’s 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