Your browser doesn't support javascript.
loading
Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.
Davit, Barbara M; Chen, Mei-Ling; Conner, Dale P; Haidar, Sam H; Kim, Stephanie; Lee, Christina H; Lionberger, Robert A; Makhlouf, Fairouz T; Nwakama, Patrick E; Patel, Devvrat T; Schuirmann, Donald J; Yu, Lawrence X.
Affiliation
  • Davit BM; Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 7520 Standish Place, Metro Park North One, Rockville, Maryland 20855, USA. barbara.davit@fda.hhs.gov
AAPS J ; 14(4): 915-24, 2012 Dec.
Article in En | MEDLINE | ID: mdl-22972221
Subject(s)
Fulltext
Add to My VHL
Print
XML
PubMed Links
Search on Google

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pharmaceutical Preparations / Drugs, Generic / Drug Approval Limits: Humans Country/Region as subject: America do norte Language: En Journal: AAPS J Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2012 Document type: Article Affiliation country: United States
Fulltext
Add to My VHL
Print
XML
PubMed Links
Search on Google

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pharmaceutical Preparations / Drugs, Generic / Drug Approval Limits: Humans Country/Region as subject: America do norte Language: En Journal: AAPS J Journal subject: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Year: 2012 Document type: Article Affiliation country: United States