Non-clinical evaluation of ventricular repolarization (ICH S7B): Results of an interim survey of international pharmaceutical companies

Author:

Friedrichs Gregory S.,Patmore Leslie,Bass Alan

Publisher

Elsevier BV

Subject

Pharmacology,Toxicology

Reference16 articles.

1. ICH S7A safety pharmacology studies for human pharmaceuticals, implemented by MHLW, CPMP, FDA;Anon;Federal Register,2001

2. Title 21 Code of Federal Regulations (21 CFR Part 11) Electronic Records; Electronic Signatures;Anon,2003

3. Anon. (2004). ICH S7B Note for guidance on safety pharmacology studies for assessing the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. Step 2 Revised, 10 June 2004. CPMP/ICH/423/02.

4. Origins, practices and future of safety pharmacology;Bass;Journal of Pharmacological and Toxicological Methods,2004

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