Zdrowie i gospodarka · 06/10/1997

Guidance for Industry on SUPAC-MR, Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes for Chemistry, Manufacturing, and Controls; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``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.'' The purpose of this guidance document is to provide insight and recommendations to pharmaceutical sponsors of new drug applications (NDA's), abbreviated new drug applications (ANDA's), and abbreviated antibiotic applications (AADA's) who intend to change the components or composition, the manufacturing (process or equipment), the scale-up/scale-down of manufacture, and/or the site of manufacture of a modified release solid oral formulation during the postapproval period. This guidance document represents the agency's current thinking on scale-up and postapproval changes (SUPAC) for modified release solid oral dosage forms regulated by the Center for Drug Evaluation and Research (CDER).