Drug design and testing,. Drug Names Chemical name- describes its molecular structure and distinguishes it from other drugs.

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 technologyGene 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