Requirements for generic anti-epileptic medicines: a regulatory perspective.
Maliepaard
Marc
M
MEB-CBG/Radboud University Medical Centre, 579, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands. m.maliepaard@cbg-meb.nl
Hekster
Yechiel A
YA
Kappelle
Arnoud
A
van Puijenbroek
Eugène P
EP
Elferink
André J
AJ
Welink
Jan
J
Gispen-de Wied
Christine C
CC
Lekkerkerker
Frits J F
FJ
D000927:Anticonvulsants / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards; D000075202:Contraindications; D057915:Drug Substitution / Q000009:adverse effects / Q000592:standards; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence* / Q000639:trends; D016568:Drugs, Generic / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000592:standards*; D004827:Epilepsy / Q000188:drug therapy* / Q000517:prevention & control; D005062:European Union; D006801:Humans; D010349:Patient Compliance / Q000523:psychology; D013810:Therapeutic Equivalency
D000927:Anticonvulsants; D016568:Drugs, Generic