Back to the future: Safety pharmacology methods and models in 2013

Journal of Pharmacological and Toxicological Methods

Volumn 68, Issue 1, 2013, Pages 1-6

  Pugsley, Michael K ^a   Authier, Simon ^b   Curtis, Michael J ^c  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^b SOLVO BIOTECHNOLOGY   (Hungary)

^c ST THOMAS HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ADVERSE DRUG REACTION; CANCER THERAPY; DATA ANALYSIS; DRUG EFFECT; DRUG INDUSTRY; DRUG MECHANISM; DRUG SAFETY; EDITORIAL; ELECTROPHYSIOLOGY; EMBRYONIC STEM CELL; EX VIVO STUDY; HEART FUNCTION; HEART MUSCLE CELL; HEART RATE VARIABILITY; HIGH THROUGHPUT SCREENING; HUMAN; IN VITRO STUDY; METHODOLOGY; NONHUMAN; PHARMACODYNAMICS; PLURIPOTENT STEM CELL; PRACTICE GUIDELINE; PRIMATE; PUBLICATION; QUANTITATIVE STRUCTURE ACTIVITY RELATION; TECHNOLOGY; VALIDATION STUDY;

PRIMATES;

EID: 84880038097     PISSN: 10568719     EISSN: 1873488X     Source Type: Journal    
DOI: 10.1016/j.vascn.2013.04.002     Document Type: Editorial

References (38)

1. Bass A.S., Vargas H.M., Valentin J.-P., Kinter L.B., Hammond T., Wallis R., et al. Safety pharmacology in 2010 and beyond: Survey of significant events of the past 10years and a roadmap to the immediate-, intermediate- and long-term future in recognition of the tenth anniversary of the Safety Pharmacology Society. Journal of Pharmacological and Toxicological Methods 2011, 64:7-15.
2. Beattie K.A., Luscombe C., Williams G., Munoz-Muriedas J., Gavaghan D.J., Cui Y., et al. Evaluation of an in silico cardiac safety assay: Using ion channel screening data to predict QT interval changes in the rabbit ventricular wedge. Journal of Pharmacological and Toxicological Methods 2013, 68:88-96.
3. Becker N., Stoelzle S., Göpel S., Guinot D., Mumm P., Haarmann C., et al. Minimized cell usage for stem cell-derived and primary cells on an automated patch clamp system. Journal of Pharmacological and Toxicological Methods 2013, 68:82-87.
4. Champeroux P., Martel E., Jude S., Laigot C., Laveissière A., Weyn-Marotte A.-A., et al. Power spectral analysis of heart rate variability in cynomolgus monkeys in safety pharmacology studies: Comparative study with beagle dogs. Journal of Pharmacological and Toxicological Methods 2013, 68:166-174.
5. Curtis M.J., Pugsley M.K. Attrition in the drug discovery process: lessons to be learned from the safety pharmacology paradigm. Expert Opinion in Clinical Pharmacology 2012, 5:237-240.
6. Elkins R.C., Davies M.R., Brough S.J., Gavaghan D.J., Cui Y., et al. Variability in high-throughput ion-channel screening data and consequences for cardiac safety assessment. Journal of Pharmacological and Toxicological Methods 2013, 68:112-122.
7. Ewart L., Milne A., Adkins D., Benjamin A., Bialecki B., Chen Y., et al. A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions. Journal of Pharmacological and Toxicological Methods 2013, 68:30-43.
8. Goineau S., Rompion S., Guillaume P., Barrais L., Castagné V. Using telemetry to automate the detection of emesis in the ferret: New vistas for delayed emesis assessment. Journal of Pharmacological and Toxicological Methods 2013, 68:160-165.
9. Henderson K.A., Borders R.B., Ross J.B., Huwar T.B., Travis C.O., Wood B.J., et al. Effects of tyrosine kinase inhibitors on rat isolated heart function and protein biomarkers indicative of toxicity. Journal of Pharmacological and Toxicological Methods 2013, 68:150-159.
10. Himmel H.M. Drug-induced functional cardiotoxicity screening in stem cell-derived human and mouse cardiomyocytes: Effects of reference compounds. Journal of Pharmacological and Toxicological Methods 2013, 68:97-111.
11. Kinter L.B., Siegl P.K.S., Bass A.S. New preclinical guidelines on drug effects on ventricular repolarization: Safety pharmacology comes of age. Journal of Pharmacological and Toxicological Methods 2004, 49:153-158.
12. Lindgren S., Bass A.S., Briscoe R., Bruse K., Friedrichs G.S., Kallman M.-J., et al. Benchmarking safety pharmacology regulatory packages and best practice. Journal of Pharmacological and Toxicological Methods 2008, 58:99-109.
13. Marks L., Beard E., Des Cobey D., Moore N., Motyer V., Valentin J.-P., et al. An evaluation of the non-invasive faecal pellet assessment method as an early drug discovery screen for gastrointestinal liability. Journal of Pharmacological and Toxicological Methods 2013, 68:123-136.
14. Mitchell A.Z., Bills A.J., Wittwer G.T., Foley C.M., Kremer J.J., Chen H., et al. Intravenous solid tip ECG lead placement in telemetry implanted dogs. Part 2: High quality telemetry signals yield high sensitivity to drug-induced changes. Journal of Pharmacological and Toxicological Methods 2013, 68:62-73.
15. Morissette P., Nishinda M., Trepakova E., Imredy J., Lagrutta A., Chaves A., et al. The anesthetized guinea pig: An effective early cardiovascular derisking and lead optimization model. Journal of Pharmacological and Toxicological Methods 2013, 68:137-149.
16. Peng S., Lacerda A.E., Kirsch G.E., Brown A.M., Bruening-Wright A. The action potential and comparative pharmacology of stem cell-derived human cardiomyocytes. Journal of Pharmacological and Toxicological Methods 2010, 61:277-286.
17. Percie du Sert N., Chu K.M., Wai M.K., Rudd J.A., Andrews P.L. Reduced normogastric electrical activity associated with emesis: A telemetric study in ferrets. World Journal of Gastroenterology 2009, 15:6034-6043.
18. Pierson J.B., Berridge B.R., Brooks M.B., Dreher K., Koerner J., Schultze A.E., et al. A public-private consortium advances cardiac safety evaluation: Achievements of the HESI Cardiac Safety Technical Committee. Journal of Pharmacological and Toxicological Methods 2013, 68:7-12.
19. Porsolt R.D. The usefulness of non-human primates in central nervous system safety pharmacology. Journal of Pharmacological and Toxicological Methods 2013, 68:23-29.
20. Pugsley M.K. Safety pharmacology matures into a unique pharmacological discipline. Journal of Pharmacological and Toxicological Methods 2004, 49:137-139.
21. Pugsley M.K. Methodology used in safety pharmacology: Appraisal of the state-of-the-art, the regulatory issues and new directions. Journal of Pharmacological and Toxicological Methods 2005, 52:1-5.
22. Pugsley M.K., Authier S., Curtis M.J. Principles of safety pharmacology. British Journal of Pharmacology 2008, 154:1382-1399.
23. Pugsley M.K., Authier S., Towart R., Gallacher D.J., Curtis M.J. Beyond the safety assessment of drug-mediated changes in the QT interval. .what's next?. Journal of Pharmacological and Toxicological Methods 2009, 60:24-27.
24. Pugsley M.K., Curtis M.J. Safety pharmacology in focus: New methods developed in the light of the ICH S7B guidance document. Journal of Pharmacological and Toxicological Methods 2006, 54(2):94-98.
25. Pugsley M.K., Curtis M.J. Safety pharmacology methods: Anticipating the transition from long QT (LQTS) to short QT syndromes (SQTS)?. Journal of Pharmacological and Toxicological Methods 2007, 56(2):87-90.
26. Pugsley M.K., Curtis M.J. Methodological innovations expand the safety pharmacology horizon. Journal of Pharmacological and Toxicological Methods 2012, 66:59-62.
27. Pugsley M.K., Towart R., Authier S., Gallacher D., Curtis M.J. Non-clinical models: Validation, study design and statistical consideration in safety pharmacology. Journal of Pharmacological and Toxicological Methods 2010, 62:1-3.
28. Pugsley M.K., Towart R., Authier S., Gallacher D.J., Curtis M.J. Innovation in safety pharmacology testing. Journal of Pharmacological and Toxicological Methods 2011, 64(1):1-6.
29. Qu Y., Gao B., Fang M., Vargas H.M. Human embryonic stem cell derived cardiac myocytes detect hERG-mediated repolarization effects, but not Nav1.5 induced depolarization delay. Journal of Pharmacological and Toxicological Methods 2013, 68:74-81.
30. Rampe D., Brown A.M. A history of the role of the hERG channel in cardiac risk assessment. Journal of Pharmacological and Toxicological Methods 2013, 68:13-22.
31. Redfern W., Valenin J.-P. Trends in safety pharmacology: Posters presented at the annual meetings of the Safety Pharmacology Society 2001-2010. Journal of Pharmacological and Toxicological Methods 2011, 64:102-110.
32. Sarazan R.D., Schweitz K.T. Standing on the shoulders of giants: Dean Franklin and his remarkable contributions to physiological measurements in animals. Advances in Physiological Education 2009, 33:144-156.
33. Tanaka T., Tohyama S., Murata M., et al. In vitro pharmacologic testing using human induced pluripotent stem cell-derived cardiomyocytes. Biochemical and Biophysical Research Communications 2009, 385:497-502.
34. US F.D.A. ICHS7A: Safety pharmacology studies for human pharmaceuticals. Federal Register 2001, 66:36791-36792.
35. US FDA ICH harmonized tripartite guideline S7B. Safety pharmacology assessment of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals Available at:. http://www.ich.org/cache/compo/276-254-1.html.
36. Valentin J.-P., Hammond T.G. Safety and secondary pharmacology: Successes, threats, challenges and opportunities. Journal of Pharmacological and Toxicological Methods 2008, 58:77-87.
37. Vidarsson H., Hyllner J., Sartipy P. Differentiation of human embryonic stem cells to cardiomyocytes for in vitro and in vivo applications. Stem Cell Reviews 2010, 6:108-120.
38. Walisser J.A., Mitchell A.Z., Bills A.J., Sharma A.K., Latimer K., Taschwer M., et al. Intravenous solid tip lead placement in telemetry implanted dogs. Part 1: Surgical methods, signal quality, and pathological endpoints. Journal of Pharmacological and Toxicological Methods 2013, 68:52-61.