Detection and impact of hysteresis when evaluating a drug’s QTc effect using concentration-QTc analysis

Author:

Ferber Georg,Darpo Borje,Garnett Christine,Huang Dalong,Marathe Dhananjay D.,Sun Yaning,Liu Jiang

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology

Reference17 articles.

1. ICH. ICH E14 Guideline. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (2005). Available at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E14/E14_Guideline.pdf. Accessed 21 April 2020

2. ICH E14 Implementation Working Group. ICH E14 Guideline. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs: questions & answers (R3) (2015). Available at: https://database.ich.org/sites/default/files/E14_Q%26As_R3_Q%26As.pdf. Accessed 21 April 2020

3. Garnett C, Garnett C, Bonate PL, Dang Q, Ferber G, Huang D, Liu J, Mehrotra D, Riley S, Sager P, Tornoe C, Wang Y (2018) Scientific white paper on concentration-QTc modeling. J Pharmacokinet Pharmacodyn 45(3):383–397. https://doi.org/10.1007/s10928-017-9558-5

4. Garnett C, Needleman K, Liu J, Brundage R, Wang Y (2016) Operational characteristics of linear concentration-QT models for assessing QTc interval in the thorough QT and Phase I clinical studies. Clin Pharmacol Ther 100(2):170–178. https://doi.org/10.1002/cpt.361

5. FDA briefing document—anesthetic and analgesic drug products advisory committee October 11, 2018. https://www.fda.gov/media/121233/download

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