title: Comparative Risk Assessment of Formulation Changes in Generic Drug Products: A Pharmacology/Toxicology Perspective.
abstract: This review highlights general toxicology concerns caused by formulation differences between generic and innovator drugs. It underscores the importance of a scientific, clinically oriented, evidence-based comparative safety evaluation procedure for generic drugs and discusses representative case studies from a pharmacology-toxicology perspective. For consideration by generic drug industry stakeholders, this article provides an overview of comparative risk assessments for generic drug products.
authors.affiliation: Division of Clinical Review, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993 sree.rayavarapu@fda.hhs.gov.
authors.forename: Sree
authors.initials: S
authors.lastname: Rayavarapu
authors.affiliation: Division of Clinical Review, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993.
authors.forename: Elena
authors.initials: E
authors.lastname: Braithwaite
authors.affiliation: Division of Clinical Review, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993.
authors.forename: Robert
authors.initials: R
authors.lastname: Dorsam
authors.affiliation: Division of Clinical Review, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993.
authors.forename: James
authors.initials: J
authors.lastname: Osterhout
authors.affiliation: Division of Clinical Review, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993.
authors.forename: Lesley-Anne
authors.initials: LA
authors.lastname: Furlong
authors.affiliation: Division of Clinical Review, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993.
authors.forename: Daiva
authors.initials: D
authors.lastname: Shetty
authors.affiliation: Division of Clinical Review, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland 20993.
authors.forename: John R
authors.initials: JR
authors.lastname: Peters
mesh_terms: D002626:Chemistry, Pharmaceutical; D016568:Drugs, Generic / Q000009:adverse effects; D005079:Excipients; D018570:Risk Assessment
chemical_list: D016568:Drugs, Generic; D005079:Excipients
keywords: excipients; generics; impurities; reference listed drug; residual solvents; toxicity