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indialong

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indialong

Re: None

Wednesday, 04/10/2019 7:23:53 PM

Wednesday, April 10, 2019 7:23:53 PM

Post# of 458816
"Although including a placebo group in dose-response studies is desirable, it is not theoretically necessary in all cases; a positive slope, even without a placebo group, provides evidence of a drug effect."

See page 9:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073115.pdf
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