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Titolo:
Prolongation of repolarization in pre-clinical investigations and phase I/II clinical trials: what should be done?
Autore:
Sponer, G;
Indirizzi:
Univ Heidelberg, Inst Pharmacol & Toxicol, D-68169 Mannheim, Germany Univ Heidelberg Mannheim Germany D-68169 icol, D-68169 Mannheim, Germany
Titolo Testata:
EUROPEAN HEART JOURNAL SUPPLEMENTS
fascicolo: K, volume: 3, anno: 2001,
pagine: K101 - K104
SICI:
1520-765X(200109)3:K<K101:PORIPI>2.0.ZU;2-T
Fonte:
ISI
Lingua:
ENG
Soggetto:
QT INTERVAL PROLONGATION; QT(C) INTERVAL; DRUG;
Keywords:
action potential; QT prolongation; drug development;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
11
Recensione:
Indirizzi per estratti:
Indirizzo: Sponer, G Univ Heidelberg, Inst Pharmacol & Toxicol, Maybachstr 14-16, D-68169 Mannheim, Germany Univ Heidelberg Maybachstr 14-16 Mannheim Germany D-68169 rmany
Citazione:
G. Sponer, "Prolongation of repolarization in pre-clinical investigations and phase I/II clinical trials: what should be done?", EUR H J SUP, 3(K), 2001, pp. K101-K104

Abstract

In the past, some non-cardiovascular drugs have been identified as prolonging repolarization and evoking torsade de pointes. Concerns prompted the health authorities to request detailed investigations targeted on this issue. In particular, in vitro and in vivo pre-clinical studies are regarded as mandatory in order to assess properly the potential risk of new compounds. However, appropriate assessment is only possible if the methods used are standardized and validated, which cannot currently be completely guaranteed. Additionally, a suitable threshold should also be specified in pre-clinical test systems. If some findings indicate prolongation of repolarization, further investigations are needed in order to evaluate the potential risk or to get more insight into the mode of action. However, withdrawal of the compound from further development at any stage is another alternative in order to spare resources and to avoid regulatory problems. In any case, a proper evaluation of the benefit-risk ratio is mandatory when findings indicate that a new compound may prolong repolarization. (Eur Heart J Supplements 2001; 3 (Suppl K): K101-K104) (C) 2001 The European Society of Cardiology.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 30/11/20 alle ore 19:52:12