drug design and testing,. drug names chemical name- describes its molecular structure and...
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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