Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard-Reference-Cited by-同舟云学术

Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard

Published:2015-07-23 Issue:9 Volume:56 Page:1415-1424
ISSN:0013-9580
Container-title:Epilepsia
language:en
Short-container-title:Epilepsia

Author:

Ting Tricia Y.¹,Jiang Wenlei²,Lionberger Robert²,Wong Jessica³,Jones Jace W.³,Kane Maureen A.³,Krumholz Allan¹,Temple Robert²,Polli James E.³

Affiliation:

1. Department of Neurology; University of Maryland; Baltimore Maryland U.S.A

2. Food and Drug Administration; White Oak Maryland U.S.A

3. Department of Pharmaceutical Sciences; University of Maryland; Baltimore Maryland U.S.A

Funder

FDA

University of Maryland Clinical Translational Science Institute

University of Maryland General Clinical Research Center

Publisher

Wiley

Subject

Neurology (clinical),Neurology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/epi.13095/fullpdf

Reference44 articles.

1. Understanding the scientific issues embedded in the generic drug approval process;Welage;J Am Pharm Assoc,2001

2. IMS Institute for Healthcare Informatics Medicine Use and Shifting Costs of Healthcare: A Review of the Use of Medicines in the United States in 2013 http://www.imshealth.com/cds/imshealth/Global/Content/Corporate/IMS%20Health%20Institute/Reports/Secure/IIHI_US_Use_of_Meds_for_2013.pdf

3. Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy;Liow;Neurology,2007

4. American Epilepsy Society Position Statement on the Substitution of Different Formulations of Antiepileptic Drugs for the Treatment of Epilepsy https://www.aesnet.org/sites/default/files/file_attach/AboutAES/PositionStatements/position%20statement%20on%20substitution%20of%20generic%20formulations.pdf

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