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indialong

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indialong

Re: Steady_T post# 201806

Sunday, 07/21/2019 2:40:43 PM

Sunday, July 21, 2019 2:40:43 PM

Post# of 462356
Steady T

"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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