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Bioequivalence documentation

CDER Guidance for Industry. 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 US Food and Drug Administration, 1995. [Pg.529]

FDA. Guidance for industry SUPAC-SS In-vitro release testing and in-vivo bioequivalence documentation, Center for Drug Evaluation and Research (CDER), 1997. [Pg.24]

FDA, September 1997, Guidance for Industry SUPAC-MR modified release solid oral dosage forms scale-up and post-approval changes chemistry, manufacturing and controls, in vitro dissolution testing, and in vitro bioequivalence documentation. [Pg.323]

SUPAC-MR Modified release solid oral dosage forms. Scale-up and postapproval changes chemistry, manufacturing, and controls in vitro dissolution testing and in vivo bioequivalence documentation (September 1997). [Pg.529]

IN VITRO DISSOLUTION TESTING, AND IN YIYO BIOEQUIVALENCE DOCUMENTATION... [Pg.35]

In vivo bioequivalence documentation is not required for level 2. If the product does not meet any of the level 1 cases above, refer to level 3 changes. [Pg.38]

Required documentation—No documentation is required beyond the usual application/compendial requirements. No in vivo bioequivalence documentation is required. [Pg.39]

In vivo bioequivalence documentation—An in vivo bioequivalence study should be performed. This may be waived if a suitable in vivo/in vitro correlation has been verified. [Pg.42]

SUPAC-SS Nonsterile semisolid dosage forms scale-up and post-approval changes Chemistry, manufacturing and controls in vitro release testing and in vivo bioequivalence documentation http //www.fda.gov/cder/guidance/1447fnl. pdf... [Pg.43]

In vivo bioequivalence documentation Full bioequivalence study. [Pg.335]


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Bioequivalence studies guidance documents

Bioequivalency

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