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`~p://www.nlm.nih gov/services/ctphases.html
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`10JanO1-2No, 16
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`I
`II I IIIIIIIIIIIIII I IIIllll Illlil i ~11
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`I h~ii&
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`2000
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`Frequently Asked Questions
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`Hea~th |nformation
`
`Library Services
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`Research Programs
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`New & Noteworthy
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`General information
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`ClinicalTrials.gov - Clinical Trial Phases
`
`Question: What are clinical trial phases?
`
`Answer:
`¯ -Clinical trials of experimental drugs proceed through four phases:
`
`- In Phase I clinical trials, researchers test a new drug or
`treatment in a small group of people for the first time to evaluate
`its safety, determine a safe dosage range, and identify side
`effects.
`
`o _ In Phase II clinical trials, the study drug or treatment is given
`to a larger group of people to see if it is effective and to further
`evaluate its safety.
`
`- In Phase III studies, the study drug or treatment is given
`usually to large groups of people to confirm its effectiveness,
`monitor side effects, compare it to commonly used treatments,
`and collect information that will allow the drug or treatment to
`be used safely.
`
`- Phase IV studies are done after the drug or treatment has been
`marketed. These studies continue testing the study drug or
`treatment to collect information about its effect in various
`populations and any side effects associated with long-term use.
`
`Related Questions:
`ClinicalTrials.go_v cluestions
`
`Return to the top [ Return to the list of FAQs
`http.’!/ww~4,.nlm.nih.~ov/services/ctphases.html
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`U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
`National Institutes of Health
`D__~partment of Health & Human Services
`C___opyri.qht and Privacy Policy.
`Last updated: 19 May 2000
`
`https://web.archive.org/web/20010110182400/http ://www.nlm.nih.gov/services/ctphases.ht... 11/2/2016
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1063-0001
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