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Effect compassionate use certain drugs are certain

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Unformatted text preview: that have limited ---drugs use—treat rare or unusual diseases (usually effect less than 200,000 people). effect Compassionate Use---certain drugs are --certain available to patients without complete FDA approval---life-threatening diseases. (HIV drugs) drugs) Expedited Process---shorten process for --shorten diseases that may produce a public health threat (AIDS) threat 47 New Drug Development New Randomized Controlled Trial (RCTs) Randomized Use of controls Randomization Blinding 48 Stages of New Drug Development Stages 1. 2. 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 trials trials Phase III: Extended clinical evaluation---drug Phase approval process (NDA) approval Phase IV: Post marketing surveillance---survey Phase for harmful drug effects in larger population for 49 Limitations of the Testing Procedure Procedure Limited information for women and Limited children children – Women...
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