title: Dissolution testing for generic drugs: an FDA perspective.
abstract: In vitro dissolution testing is an important tool used for development and approval of generic dosage forms. The objective of this article is to summarize how dissolution testing is used for the approval of safe and effective generic drug products in the United States (US). Dissolution testing is routinely used for stability and quality control purposes for both oral and non-oral dosage forms. The dissolution method should be developed using an appropriate validated method depending on the dosage form. There are several ways in which dissolution testing plays a pivotal role in regulatory decision-making. It may be used to waive in vivo bioequivalence (BE) study requirements, as BE documentation for Scale Up and Post Approval Changes (SUPAC), and to predict the potential for a modified-release (MR) drug product to dose-dump if co-administered with alcoholic beverages. Thus, in vitro dissolution testing plays a major role in FDA's efforts to reduce the regulatory burden and unnecessary human studies in generic drug development without sacrificing the quality of the drug products.
authors.affiliation: U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Rockville, Maryland 20855, USA. om.anand@fda.hhs.gov
authors.forename: Om
authors.initials: O
authors.lastname: Anand
authors.forename: Lawrence X
authors.initials: LX
authors.lastname: Yu
authors.forename: Dale P
authors.initials: DP
authors.lastname: Conner
authors.forename: Barbara M
authors.initials: BM
authors.lastname: Davit
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D017277:Drug Approval; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D016568:Drugs, Generic / Q000032:analysis / Q000737:chemistry / Q000592:standards; D012995:Solubility; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic