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 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

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. 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

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