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

Epilepsia

Volumn 56, Issue 9, 2015, Pages 1415-1424

  Ting, Tricia Y ^a   Jiang, Wenlei ^b   Lionberger, Robert ^b   Wong, Jessica ^c   Jones, Jace W ^c   Kane, Maureen A ^c   Krumholz, Allan ^a   Temple, Robert ^b   Polli, James E ^c  

^a UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c UNIVERSITY OF MARYLAND   (United States)

Author keywords

Bioequivalence; Generic brittle; Lamotrigine; Narrow therapeutic index; Switchability

Indexed keywords

GENERIC DRUG; LAMOTRIGINE; VALPROIC ACID; ANTICONVULSIVE AGENT; DRUG; TRIAZINE DERIVATIVE;

ADULT; AGED; ANTICONVULSANT THERAPY; AREA UNDER THE CURVE; AREA UNDER THE CURVE RATIO; ARTICLE; BIOEQUIVALENCE; BLURRED VISION; CLINICAL ARTICLE; COMORBIDITY; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; EPILEPSY; FEMALE; FOCAL EPILEPSY; FOOD AND DRUG ADMINISTRATION; GENERALIZED EPILEPSY; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; MEDICATION COMPLIANCE; MINIMUM PLASMA CONCENTRATION; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEIZURE; STEADY STATE; THERAPEUTIC EQUIVALENCE; VOMITING; DOSE RESPONSE; MIDDLE AGED; RETRACTED ARTICLE; STANDARDS; TREATMENT OUTCOME; UNITED STATES; YOUNG ADULT;

ADULT; AGED; ANTICONVULSANTS; AREA UNDER CURVE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUGS, GENERIC; EPILEPSY; FEMALE; HUMANS; MALE; MIDDLE AGED; PHARMACEUTICAL PREPARATIONS; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME; TRIAZINES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; YOUNG ADULT;

EID: 84940955048     PISSN: 00139580     EISSN: 15281167     Source Type: Journal    
DOI: 10.1111/epi.13095     Document Type: Article

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