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1. DRUG´S DEVELOPMENT
Alex Julián Pacheco Peláez
RN/High Education Especialist.

2. GLOSSARY

3. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm

4. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm

5. SEQUENTIAL PROCESS
• Process of discovering, developing and bringing to the market, a
new ethical drug product
• Drug must be proved to be safe and effective

6. DRUG DEVELOPED

7. PRE – CLINICAL PHASE
• Test on animals for toxicity.

8. CLINICAL PHASE
SAFETY
SAFETY AND EFFECTIVINESS

9. CLINICAL PHASE
phase III

10. NEW DRUG APPLICATION
REVIEW
• NDA: Positive previous testing
• Information from DRUG DEVELOPMENT to phase III
(CLINICAL PHASE).
– Animal and human data and analyses of the data.
– New drug behaves in the body.
– New drug manufactured.
• Post – marketing studies.
– SAFETY and EFFICACY during long term use.
– Submit periodic safety data

11. RAJENDRA SADARE

12. RICHARD M. COOK