Non-sterile semisolid dosage forms

The Food and Drug Administration (FDA) has issued a guidance document (SUPAC-SS Non-sterile Semisolid Dosage Forms, US Department of Health... 

SUPAC-SS Non-sterile Semisolid Dosage Forms Scale-Up and Post-Approval Changes Chemistry, Manufacturing and Controls In Vitro Release Testing and In Vivo Bioequieva-lence Documentation (Issued 5/1997 Posted 6/16/1997, Addendum Issued 12/1998). 

Shah, V.P. FDA guidance for industry document. In Non-sterile Semisolid Dosage Forms Center for Drug Evaluation and Research Rockville, MD, 1997 1-40. 

On the other hand, the comparability of the drug substance and excipients with those of the innovators product listed by the FDA as the Reference Listed Drug (RLD), assumes (under the FDA s SUPAC guidelines) considerably greater importance for sterile and non-sterile semisolid formulations than, for solid oral dosage forms. With the semisolid dosage forms, the FDA uses various types of diffusion analyses in lieu of dissolution as a surrogate for in vivo bioequivalence. 

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