Zdrowie i gospodarka · 30/11/1995

Immediate Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing; In Vivo Bioequivalence Documentation; Guidance

The Food and Drug Administration (FDA) is publishing a guidance entitled ``Immediate Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing; In Vivo Bioequivalence Documentation.'' The guidance sets forth application information that should be provided to the Center for Drug Evaluation and Research (CDER) to assure continuing product quality and performance characteristics of immediate release solid oral dose formulations for specified changes. The guidance fulfills a commitment made in the President's National Performance report, ``Reinventing Drug and Medical Device Regulations,'' April 1995, to reduce through guidance the number of manufacturing changes that require preapproval by FDA. The guidance provides recommendations to sponsors of new drug applications (NDA's), abbreviated antibiotic applications (AADA's), and abbreviated new drug applications (ANDA's) who intend, during the postapproval period, to change the components or composition of the drug, site of manufacture, scale-up/scale-down of manufacture, and/or manufacturing process or equipment. The guidance was prepared by the Immediate Rel