Status of Safety Pharmacology and Present Guidelines

Author:

Hock Franz J.,Bode Gerd

Publisher

Springer International Publishing

Reference106 articles.

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2. Anderson ME, Al-Khatib SM, Roden DM, Califf RM (2002) Cardiac repolarization: current knowledge, critical gaps and new approaches to drug development and patient management. Am Heart J 144:769–781

3. Anon (2008) Guidance for industry diabetes mellitus – evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. U.S. Department of Health and Humans Services, Food and Drug Administration, Center for Drug Evaluation and Research, December 2008. http://www.fda.gov/downloads/drugs/GuidanceComplianceRegulatoryInformation/guidances/UCM071627.pdf

4. Anonymous (2022a) ICH E14/S7B implementation working group: clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential questions and answers. https://database.ich.org/sites/default/files/E14-S7B_QAs_Step4_2022_0221.pdf. Accessed 27 Oct 2023

5. Anonymous (2022b) ICH E14/S7B implementation working group: E14/S7B questions and answers: clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential. Training Materials. https://database.ich.org/sites/default/files/ICH_E14-S7B_TrainingMaterial_2022_0407.pdf. Accessed 27 Oct 2023

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