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Unformatted text preview: that have limited
---drugs use—treat rare or unusual diseases (usually
effect less than 200,000 people).
Compassionate Use---certain drugs are
available to patients without complete FDA
approval---life-threatening diseases. (HIV
Expedited Process---shorten process for
diseases that may produce a public health
47 New Drug Development
Randomized Controlled Trial (RCTs)
Use of controls
Blinding 48 Stages of New Drug Development
3. Preclinical testing
Clinical testing---may take 2-10 years
Human studies: Phase I: Initial pharmacologic evaluation--laboratory research
Phase II: Limited controlled evaluation---clinical
Phase III: Extended clinical evaluation---drug
approval process (NDA)
Phase IV: Post marketing surveillance---survey
for harmful drug effects in larger population
49 Limitations of the Testing
Limited information for women and
children – Women...
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This document was uploaded on 03/25/2014.
- Spring '14