Dissolution Regulations

sort by Title sort by   Date    Download  Average, Population, and Individual Approaches to Establishing Bioequivalence This guide provides recommendations to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs) who intend, either before or after approval, to perform in vivo or in vitro bioequivalence (BE) studies, FDA  1999-08-01    PDF file (325 KB)  Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action This guide is intended to provide recommendations to applicants who are planning product quality studies to measure bioavailability (BA) and/or establish (BE) in support of new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for locally acting drugs in nasal aerosols (metered-dose inhalers (MDIs)) and nasal sprays (metered-dose spray pumps), FDA  1999-06-01    PDF file (113 KB)  Dissolution Testing of Immediate Release Solid Oral Dosage Forms This guide has been developed for immediate release (IR) dosage forms and is intended to provide (1) general recommendations for dissolution testing; (2) approaches for setting dissolution specifications related to the biopharmaceutic characteristics of a drug substance; (3) statistical methods for comparing dissolution profiles; and (4) a process to help determine when dissolution testing is sufficient to grant a waiver for an in vivo bioequivalence study, FDA  1999-06-01    PDF file (116 KB)  Food-Effect Bioavailability and Bioequivalence Studies This document provides guidance to sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and abbreviated antibiotic drug applications (AADAs) who intend to conduct food-effect bioavailability (BA) and bioequivalence (BE) studies for oral immediate release (IR) or modified release (MR) dosage forms. FDA  1997-10-01    PDF file (42 KB)  Levothyroxine Sodium Tablets - In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing This guide is intended to assist sponsors of new drug applications (NDAs) for levothyroxine sodium tablets who wish to conduct in vivo harmacokinetic and bioavailability studies and in vitro dissolution testing of their products, FDA  2000-12-01    PDF file (30 KB)  Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (NDAs), abbreviated new drug applications (ANDAs), and abbreviated antibiotic drug applications (AADAs) who intend to change (1) the components or composition, (2) the manufacturing (process and equipment), (3) the scale-up/scale-down of manufacture, and/or (4) the site of manufacture of a semisolid formulation during the post approval period. FDA  1997-05-01    PDF file (98 KB)  Oral Extended (Controlled) Release Dosage Forms in Vivo Bioequivalence and in Vitro Dissolution Testing This guide describes in vivo bioequivalence studies and in vitro dissolution testing recommended to applicants intending to submit Abbreviated New Drug Applications (ANDA's) for extended release products administered orally. FDA      PDF file (31 KB)  Quality of Modified Release Products: A: Oral Dosage Forms B: Transdermal Dosage Forms, Section I (Quality) This Note for Guidance concerns quality aspects, especially, in vitro testing, of dosage forms in which release of active substance is modified. EMEA  1999-07-01    PDF file (74 KB)  SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum This guide provides recommendations to pharmaceutical manufacturers using the Center for Drug Evaluation and Research's Guidance for Industry: 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 (SUPAC-IR)  1998-04-01    PDF file (119 KB)  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 This guide provides recommendations to pharmaceutical sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and abbreviated antibiotic drug applications (AADAs) who intend to change (1) the components or composition, (2) the site of manufacture, (3) the scale-up/scale-down of manufacture, and/or (4) the manufacturing (process and equipment) of a modified release solid oral dosage form during the post approval period. FDA  1997-09-01    PDF file (176 KB)  The Investigation of Bioavailability and Bioequivalence The objective of this guide to define, for products with a systemic effect, when bioavailability or bioequivalence studies are necessary and to formulate requirements for their design, conduct, and evaluation.  1998-12-01    PDF file (84 KB)  Topical Dermatological Drug Product NDAs and ANDAs - In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated Studies This guide provides recommendations to sponsors and applicants who intend to provide, during either the pre- or postapproval period, information on bioavailability (BA) and bioequivalence (BE), and chemistry, manufacturing and controls in support of a new drug application (NDA), an abbreviated new drug application (ANDA), or a supplement for topical dermatological drug products.  1999-06-01    PDF file (117 KB)  Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active Ingredients Based on a Biopharmaceutics Classification System The purpose of this guide is to describe alternative methods, not based on in vivo methods, that are acceptable to FDA for demonstrating bioequivalence for certain post-1962 immediate release solid oral drug products based on a classification system that distinguishes rapidly dissolving drug products containing active moieties/active ingredients that are highly soluble and highly permeable from other drug products.  1999-01-01    PDF file (41 KB)

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