DRUG´S DEVELOPMENT

Alex Julián Pacheco Peláez

RN/High Education Especialist.

GLOSSARY

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

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

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

DRUG DEVELOPED

PRE – CLINICAL PHASE

• Test on animals for toxicity.

CLINICAL PHASE

SAFETY

SAFETY AND EFFECTIVINESS

CLINICAL PHASE phase III

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

RAJENDRA SADARE

RICHARD M. COOK