Scale Up and Post-Approval Changes

Multidrug resistant-related protein family Polar molecular surface area Solubilization ratio Scale-up and post-approval changes... 

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. 

Dissolution is also used to identify bioavailability (BA) problems and to assess the need for further BE studies relative to scale-up and post-approval Changes (SUPAC), where it functions as a signal of bioinequivalence. In vitro dissolution studies for all product formulations investigated (including prototype formulations) are encouraged, particularly if in vivo absorption characteristics can be defined for the different product formulations. With such efforts, it may be possible to achieve an in vitro/in vivo correlation. When an in vitro correlation or association is available, the in vitro test can serve not only as a quality control (QC) specification for the manufacturing process, but also as an indicator of in vivo product performance. 

In 1995, the FDA issued Scale-up and Post-Approval Changes (SUPAC) guidance for the industry (128) for immediate release dosage forms and in 1997, SUP AC MR guidance was released for modified release dosage forms (129). 

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. 

The regulatory aspects of scale-up and post-approval changes are addressed in detail throughout the book and in a separate chapter. A diligent attempt was made to keep all references to the Food and Drug Administration (FDA) regulations as complete and current as possible. 

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... 

Augsburger, L. L., Shangraw, R., Lesko, L. J., and Williams, R. W. An approach toward establishing a scientific foundation for interpreting regulations and workshop reports on scale-up and post approval changes. Pharm. Res. ll(10) S-143,1994. 

This guidance has been prepared by the Immediate Release Scale-up and Post Approval Change (SU-... 

As mentioned above, the FDA also has issued SUPAC (scale up and post approval changes) guidelines that list filling and data requirements for many of the most common types of changes. In this chapter, these finalized guidelines will be reviewed to ensure a thorough understanding. 

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