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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.

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Drug design and testing,

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Drug design and testing l.jpg

Drug design and testing,


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Drug Names

  • Chemical name- describes its molecular structure and distinguishes it from other drugs


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  • Generic name- is determined by the pharmaceutical company along with the a special organization known as the U.S. Adopted names Council


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  • 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.


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  • The particular spelling of a brand name drug is proposed by a manufacture for one of several reasons.


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To indicate the disease process being treated

  • Azmacort- treats asthma

  • Rythmol- treats cardiac arrhythmias


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To simplify the generic name

  • Pseudoephedrine to Sudefed

  • Haloperidol to Haldol

  • Ciprofloxacin to Cipro


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To indicate the duration

  • Slow-K slow release potassium supplement


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Drug Design

  • New drugs are discovered in one of two ways

  • Totally new chemical substance

  • Derived from molecular manipulation of a current drug


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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


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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


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Testing

  • In vitro- in glass

  • In vivo- in living

  • many guidelines set by FDA


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Animal Phase

  • Precedes human testing

  • watching for toxic effects,side effects, addictions, cancerous tumors or fetal deformities


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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


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Animal Phase

  • NOT always a reliable indicator of how well a drug will perform in humans.


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Human Testing

  • 3 phases

  • 1st phase- Healthy volunteers used to study a safe dose range, evaluate side effects and establish a correct dosage.

  • Absorption


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PhaseII

  • 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


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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


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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


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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


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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


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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


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