Elite Pharmaceuticals Inc (ELTP): Page 3, "Sponsors may wish to use re...

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Re: toofun post# 239133

Monday, 01/16/2017 9:51:39 AM

Monday, January 16, 2017 9:51:39 AM

Page 3,

"Sponsors may wish to use relevant principles described in the guidance for industry on SUPAC-IR: Immediate Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (SUPAC-IR guidance) to determine if in vivo BE studies are recommended. These BE studies, if indicated, should generally be conducted under fasting conditions."

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126833.pdf

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