Drug design and testing,

1. Drug design and testing,

2. Drug Names • Chemical name- describes its molecular structure and distinguishes it from other drugs

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

4. 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.

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

6. To indicate the disease process being treated • Azmacort- treats asthma • Rythmol- treats cardiac arrhythmias

7. To simplify the generic name • Pseudoephedrine to Sudefed • Haloperidol to Haldol • Ciprofloxacin to Cipro

8. To indicate the duration • Slow-K slow release potassium supplement

9. Drug Design • New drugs are discovered in one of two ways • Totally new chemical substance • Derived from molecular manipulation of a current drug

10. 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

11. 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

12. Testing • In vitro- in glass • In vivo- in living • many guidelines set by FDA

13. Animal Phase • Precedes human testing • watching for toxic effects,side effects, addictions, cancerous tumors or fetal deformities

14. 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

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

16. Human Testing • 3 phases • 1st phase- Healthy volunteers used to study a safe dose range, evaluate side effects and establish a correct dosage. • Absorption

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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