Scale-up and post approval changes SUPAC

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). 

Guidance for Industry (1997) Scale-up and post-approval changes (SUPAC-MR) Chemistry, manufacturing, and control in vitro dissolution testing and in vivo bioequivalence documentation. U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER). September 1997... 

FDA Guidance for Industry, Extended release oral solid dosage forms, scale up and post approval changes (SUPAC-MR). PDA CDER, USA, 1997. 

Roiier Compaction Technoiogy for the Pharmaceuticai industry / 3159 Sait Forms Pharmaceuticai Aspects / 3177 Scale-Up and Post Approval Changes (SUPAC) / 3188 Scale-Up of Solid Dosage Forms / 3193... 

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