Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agents.
Expert Opin Drug Saf. 2008 May;7(3):305-18
Authors: Sarapa N, Britto MR
Filed Under:
ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis.
Expert Opin Drug Saf. 2005 May;4(3):509-30
Authors: Cavero I, Crumb W
Filed Under:
The availability and content of dental instrument manufacturers' decontamination information.
Br Dent J. 2008 Apr 26;204(8):E14; discussion 444-5
Authors: Roebuck EM, Strang R, Green I, Smith A, Walker J
Filed Under:
Drugs, QT interval prolongation and ICH E14: the need to get it right.
Drug Saf. 2005;28(2):115-25
Authors: Shah RR
Filed Under:
Are we equal in death? Avoiding diagnostic error in brain death.
Neurology. 2008 Jan 22;70(4):e14-5
Authors: Laureys S, Fins JJ
Filed Under:
Pharmacovigilance-related topics at the level of the International Conference on Harmonisation (ICH).
Pharmacoepidemiol Drug Saf. 2005 Jun;14(6):377-87
Authors: Bahri P, Tsintis P
Filed Under:
Performance characteristics for some typical QT study designs under the ICH E-14 guidance.
J Clin Pharmacol. 2008 Feb;48(2):215-24
Filed Under:
The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome.
Eur J Clin Pharmacol. 2002 Dec;58(9):573-80
Filed Under:
Use of ANOVA to estimate inter- and intra-reader variability for a group of readers in thorough QT/QTc studies.
Clin Pharmacol Ther. 2008 Mar;83(3):489-91
Authors: Natekar M, Mahajan V, Satra A, O'Kelly M, Karnad DR
Filed Under:
Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology.
Crit Rev Oncol Hematol. 2002 May;42(2):123-35
Filed Under:
