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. 

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

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. 

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). 

IN VITRO DISSOLUTION TESTING, AND IN YIYO BIOEQUIVALENCE DOCUMENTATION... 

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. 

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

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. 

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... 

In vivo bioequivalence documentation Full bioequivalence study. 

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