SUPAC 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. 

SUPAC Dissolution Profile Comparison Supporting Post-approval Changes... 

For IR forms, the SUPAC-IR guidance (15) distinguishes between the following classes of change ... 

Analogously, the SUPAC-MR guidance (1,2) defines level of changes for ... 

Figure 4 Postapproval changes of IR forms supported by in vitro dissolution data according to SUPAC-IR guidance.

I The composition of the new product is similar to an existing product i.e. slight changes in the product covered by SUP AC IR level 1 change (SUPAC, 1995) and is analysed by analytical procedures with which the receiving laboratory already has experience. 

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. 

SUPAC-SS Nonsterile semisolid dosage forms. Scale-up and postapproval changes chemistry, manufacturing, and controls in vitro release testing and in vivo bioequivalence documentation (May 1997). 

GUIDANCE FOR INDUSTRY IMMEDIATE-RELEASE SOLID ORAL DOSAGE FORMS SCALE-UP AND POSTAPPROYAL CHANGES (SUPAC)—CHEMISTRY, MANUFACTURING AND CONTROLS,... 

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