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Items: 1 to 50 of 163

1.

Neurofunctional test batteries in safety pharmacology - Current and emerging considerations for the drug development process.

Jackson SJ, Authier S, Brohmann H, Goody SMG, Jones D, Prior H, Rosch A, Traebert M, Tse K, Valentin JP, Milne A.

J Pharmacol Toxicol Methods. 2019 Nov - Dec;100:106602. doi: 10.1016/j.vascn.2019.106602. Epub 2019 Jun 22.

2.

Response of safety pharmacologists to challenges arising from the rapidly evolving changes in the pharmaceutical industry.

Bass AS, Pugsley MK, Sannajust F, Yoshinaga T, Valentin JP.

J Pharmacol Toxicol Methods. 2019 Jul - Aug;98:106593. doi: 10.1016/j.vascn.2019.106593. Epub 2019 May 31. Review.

PMID:
31158459
3.

Optimizing drug discovery by Investigative Toxicology: Current and future trends.

Beilmann M, Boonen H, Czich A, Dear G, Hewitt P, Mow T, Newham P, Oinonen T, Pognan F, Roth A, Valentin JP, Van Goethem F, Weaver RJ, Birk B, Boyer S, Caloni F, Chen AE, Corvi R, Cronin MTD, Daneshian M, Ewart LC, Fitzgerald RE, Hamilton GA, Hartung T, Kangas JD, Kramer NI, Leist M, Marx U, Polak S, Rovida C, Testai E, Van der Water B, Vulto P, Steger-Hartmann T.

ALTEX. 2019;36(2):289-313. doi: 10.14573/altex.1808181. Epub 2018 Dec 20.

4.

A Proof-of-Concept Evaluation of JTPc and Tp-Tec as Proarrhythmia Biomarkers in Preclinical Species: A Retrospective Analysis by an HESI-Sponsored Consortium.

Boulay E, Abernathy MM, Chui R, Friedrichs GS, Gendron-Parra N, Greiter-Wilke A, Guillon JM, Koerner JE, Menard A, Steidl-Nichols J, Pierson J, Pugsley MK, Rossman EI, Strauss D, Troncy E, Valentin JP, Wisialowski T, Authier S.

Int J Toxicol. 2019 Jan/Feb;38(1):23-32. doi: 10.1177/1091581818813601. Epub 2018 Dec 19.

PMID:
30567462
5.

Corrigendum to An overview of the safety pharmacology society strategic plan [Journal of Pharmacological and Toxicological Methods 93 (2018) 35-45].

Pugsley MK, Authier S, Koerner JE, Redfern WS, Markgraf CG, Brabham T, Correll K, Soloviev MV, Botchway A, Engwall M, Traebert M, Valentin JP, Mow TJ, Greiter-Wilke A, Leishman DJ, Vargas HM.

J Pharmacol Toxicol Methods. 2019 Jan - Feb;95:1. doi: 10.1016/j.vascn.2018.09.003. Epub 2018 Nov 3. No abstract available.

PMID:
30399523
6.

Today's Challenges to De-Risk and Predict Drug Safety in Human "Mind-the-Gap".

Weaver RJ, Valentin JP.

Toxicol Sci. 2019 Feb 1;167(2):307-321. doi: 10.1093/toxsci/kfy270.

PMID:
30371856
7.

Fatty-Acid Binding Protein 4 (FABP4) as a Potential Preclinical Biomarker of Drug-Induced Kidney Injury.

Obajdin J, Cotter M, Snelling S, Dremier S, De Ron P, Fleurance R, Valentin JP, Nogueira da Costa A, Gryshkova V.

Toxicol Sci. 2018 Dec 1;166(2):441-450. doi: 10.1093/toxsci/kfy204.

PMID:
30215792
8.

In vitro secondary pharmacological profiling: An IQ-DruSafe industry survey on current practices.

Valentin JP, Guillon JM, Jenkinson S, Kadambi V, Ravikumar P, Roberts S, Rosenbrier-Ribeiro L, Schmidt F, Armstrong D.

J Pharmacol Toxicol Methods. 2018 Sep - Oct;93:7-14. doi: 10.1016/j.vascn.2018.07.001. Epub 2018 Jul 17.

PMID:
30030184
9.

CiPA challenges and opportunities from a non-clinical, clinical and regulatory perspectives. An overview of the safety pharmacology scientific discussion.

Wallis R, Benson C, Darpo B, Gintant G, Kanda Y, Prasad K, Strauss DG, Valentin JP.

J Pharmacol Toxicol Methods. 2018 Sep - Oct;93:15-25. doi: 10.1016/j.vascn.2018.06.005. Epub 2018 Jun 27. Review.

PMID:
29958940
10.

In silico toxicology protocols.

Myatt GJ, Ahlberg E, Akahori Y, Allen D, Amberg A, Anger LT, Aptula A, Auerbach S, Beilke L, Bellion P, Benigni R, Bercu J, Booth ED, Bower D, Brigo A, Burden N, Cammerer Z, Cronin MTD, Cross KP, Custer L, Dettwiler M, Dobo K, Ford KA, Fortin MC, Gad-McDonald SE, Gellatly N, Gervais V, Glover KP, Glowienke S, Van Gompel J, Gutsell S, Hardy B, Harvey JS, Hillegass J, Honma M, Hsieh JH, Hsu CW, Hughes K, Johnson C, Jolly R, Jones D, Kemper R, Kenyon MO, Kim MT, Kruhlak NL, Kulkarni SA, Kümmerer K, Leavitt P, Majer B, Masten S, Miller S, Moser J, Mumtaz M, Muster W, Neilson L, Oprea TI, Patlewicz G, Paulino A, Lo Piparo E, Powley M, Quigley DP, Reddy MV, Richarz AN, Ruiz P, Schilter B, Serafimova R, Simpson W, Stavitskaya L, Stidl R, Suarez-Rodriguez D, Szabo DT, Teasdale A, Trejo-Martin A, Valentin JP, Vuorinen A, Wall BA, Watts P, White AT, Wichard J, Witt KL, Woolley A, Woolley D, Zwickl C, Hasselgren C.

Regul Toxicol Pharmacol. 2018 Jul;96:1-17. doi: 10.1016/j.yrtph.2018.04.014. Epub 2018 Apr 17.

11.

Predicting cardiac safety using human induced pluripotent stem cell-derived cardiomyocytes combined with multi-electrode array (MEA) technology: A conference report.

Mulder P, de Korte T, Dragicevic E, Kraushaar U, Printemps R, Vlaming MLH, Braam SR, Valentin JP.

J Pharmacol Toxicol Methods. 2018 May - Jun;91:36-42. doi: 10.1016/j.vascn.2018.01.003. Epub 2018 Feb 4.

PMID:
29355722
12.

miR-21-5p as a potential biomarker of inflammatory infiltration in the heart upon acute drug-induced cardiac injury in rats.

Gryshkova V, Fleming A, McGhan P, De Ron P, Fleurance R, Valentin JP, Nogueira da Costa A.

Toxicol Lett. 2018 Apr;286:31-38. doi: 10.1016/j.toxlet.2018.01.013. Epub 2018 Jan 31.

PMID:
29355689
13.

An overview of the safety pharmacology society strategic plan.

Pugsley MK, Authier S, Koerner JE, Redfern WS, Markgraf CG, Brabham T, Correll K, Soloviev MV, Botchway A, Engwall M, Traebert M, Valentin JP, Mow TJ, Greiter-Wilke A, Leishman DJ, Vargas HM.

J Pharmacol Toxicol Methods. 2018 Sep - Oct;93:35-45. doi: 10.1016/j.vascn.2018.01.001. Epub 2018 Jan 9. Review. Erratum in: J Pharmacol Toxicol Methods. 2019 Jan - Feb;95:1.

PMID:
29330132
14.

Can non-clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium.

Park E, Gintant GA, Bi D, Kozeli D, Pettit SD, Pierson JB, Skinner M, Willard J, Wisialowski T, Koerner J, Valentin JP.

Br J Pharmacol. 2018 Feb;175(4):606-617. doi: 10.1111/bph.14101. Epub 2018 Jan 15.

15.

An Analysis of the Relationship Between Preclinical and Clinical QT Interval-Related Data.

Pollard CE, Skinner M, Lazic SE, Prior HM, Conlon KM, Valentin JP, Dota C.

Toxicol Sci. 2017 Sep 1;159(1):94-101. doi: 10.1093/toxsci/kfx125.

PMID:
28903488
16.

The Safety Pharmacology Society salary survey.

Pugsley MK, Authier S, Brabham T, Soloviev M, Markgraf CG, Correll K, Traebert M, Greiter-Wilke A, Valentin JP, Vargas H, Botchway A, Leishman DJ, Curtis MJ.

J Pharmacol Toxicol Methods. 2017 Nov;88(Pt 1):85-91. doi: 10.1016/j.vascn.2017.08.002. Epub 2017 Aug 7.

PMID:
28797763
17.

Risk of QT prolongation and torsade de pointes associated with exposure to hydroxyzine: re-evaluation of an established drug.

Schlit AF, Delaunois A, Colomar A, Claudio B, Cariolato L, Boev R, Valentin JP, Peters C, Sloan VS, Bentz JWG.

Pharmacol Res Perspect. 2017 Apr 21;5(3):e00309. doi: 10.1002/prp2.309. eCollection 2017 Jun.

18.

Proarrhythmia liability assessment and the comprehensive in vitro Proarrhythmia Assay (CiPA): An industry survey on current practice.

Authier S, Pugsley MK, Koerner JE, Fermini B, Redfern WS, Valentin JP, Vargas HM, Leishman DJ, Correll K, Curtis MJ.

J Pharmacol Toxicol Methods. 2017 Jul;86:34-43. doi: 10.1016/j.vascn.2017.02.021. Epub 2017 Feb 20.

19.

Safety pharmacology investigations on the nervous system: An industry survey.

Authier S, Arezzo J, Delatte MS, Kallman MJ, Markgraf C, Paquette D, Pugsley MK, Ratcliffe S, Redfern WS, Stevens J, Valentin JP, Vargas HM, Curtis MJ.

J Pharmacol Toxicol Methods. 2016 Sep-Oct;81:37-46. doi: 10.1016/j.vascn.2016.06.001. Epub 2016 Jun 2.

PMID:
27263834
20.

Assessing the predictive value of the rodent neurofunctional assessment for commonly reported adverse events in phase I clinical trials.

Mead AN, Amouzadeh HR, Chapman K, Ewart L, Giarola A, Jackson SJ, Jarvis P, Jordaan P, Redfern W, Traebert M, Valentin JP, Vargas HM.

Regul Toxicol Pharmacol. 2016 Oct;80:348-57. doi: 10.1016/j.yrtph.2016.05.002. Epub 2016 May 4.

21.

Social housing of non-rodents during cardiovascular recordings in safety pharmacology and toxicology studies.

Prior H, Bottomley A, Champéroux P, Cordes J, Delpy E, Dybdal N, Edmunds N, Engwall M, Foley M, Hoffmann M, Kaiser R, Meecham K, Milano S, Milne A, Nelson R, Roche B, Valentin JP, Ward G, Chapman K.

J Pharmacol Toxicol Methods. 2016 Sep-Oct;81:75-87. doi: 10.1016/j.vascn.2016.03.004. Epub 2016 Mar 31.

22.

Human-based approaches to pharmacology and cardiology: an interdisciplinary and intersectorial workshop.

Rodriguez B, Carusi A, Abi-Gerges N, Ariga R, Britton O, Bub G, Bueno-Orovio A, Burton RA, Carapella V, Cardone-Noott L, Daniels MJ, Davies MR, Dutta S, Ghetti A, Grau V, Harmer S, Kopljar I, Lambiase P, Lu HR, Lyon A, Minchole A, Muszkiewicz A, Oster J, Paci M, Passini E, Severi S, Taggart P, Tinker A, Valentin JP, Varro A, Wallman M, Zhou X.

Europace. 2016 Sep;18(9):1287-98. doi: 10.1093/europace/euv320. Epub 2015 Nov 29.

23.

Prevention of fostamatinib-induced blood pressure elevation by antihypertensive agents.

Lengel D, Lamm Bergström E, Barthlow H, Oldman K, Musgrove H, Harmer A, Valentin JP, Duffy P, Braddock M, Curwen J.

Pharmacol Res Perspect. 2015 Oct;3(5):e00176. doi: 10.1002/prp2.176. Epub 2015 Sep 15.

24.

Paving the Route to Plasma miR-208a-3p as an Acute Cardiac Injury Biomarker: Preclinical Rat Data Supports Its Use in Drug Safety Assessment.

Glineur SF, De Ron P, Hanon E, Valentin JP, Dremier S, Nogueira da Costa A.

Toxicol Sci. 2016 Jan;149(1):89-97. doi: 10.1093/toxsci/kfv222. Epub 2015 Oct 9.

PMID:
26454886
25.

Toxicity testing in the 21st century beyond environmental chemicals.

Rovida C, Asakura S, Daneshian M, Hofman-Huether H, Leist M, Meunier L, Reif D, Rossi A, Schmutz M, Valentin JP, Zurlo J, Hartung T.

ALTEX. 2015;32(3):171-81. doi: 10.14573/altex.1506201.

26.

Renal Safety Pharmacology in Drug Discovery and Development.

Benjamin A, Nogueira da Costa A, Delaunois A, Rosseels ML, Valentin JP.

Handb Exp Pharmacol. 2015;229:323-52. doi: 10.1007/978-3-662-46943-9_13. Review.

PMID:
26091646
27.

Gastrointestinal Safety Pharmacology in Drug Discovery and Development.

Al-Saffar A, Nogueira da Costa A, Delaunois A, Leishman DJ, Marks L, Rosseels ML, Valentin JP.

Handb Exp Pharmacol. 2015;229:291-321. doi: 10.1007/978-3-662-46943-9_12. Review.

PMID:
26091645
28.

A Historical View and Vision into the Future of the Field of Safety Pharmacology.

Bass AS, Hombo T, Kasai C, Kinter LB, Valentin JP.

Handb Exp Pharmacol. 2015;229:3-45. doi: 10.1007/978-3-662-46943-9_1. Review.

PMID:
26091634
29.

Evaluation of drug-induced QT interval prolongation in animal and human studies: a literature review of concordance.

Vargas HM, Bass AS, Koerner J, Matis-Mitchell S, Pugsley MK, Skinner M, Burnham M, Bridgland-Taylor M, Pettit S, Valentin JP.

Br J Pharmacol. 2015 Aug;172(16):4002-11. doi: 10.1111/bph.13207. Epub 2015 Jul 14. Review.

30.

The Diplomate in Safety Pharmacology (DSP) certification scheme.

Authier S, Curtis MJ, Soloviev M, Redfern WS, Kallman MJ, Hamlin RL, Leishman DJ, Valentin JP, Koerner JE, Vargas HM, Botchway A, Correll K, Pugsley MK.

J Pharmacol Toxicol Methods. 2015 Sep-Oct;75:1-4. doi: 10.1016/j.vascn.2015.04.008. Epub 2015 May 8.

PMID:
25959882
31.

Renal studies in safety pharmacology and toxicology: A survey conducted in the top 15 pharmaceutical companies.

Benjamin A, Gallacher DJ, Greiter-Wilke A, Guillon JM, Kasai C, Ledieu D, Levesque P, Prelle K, Ratcliffe S, Sannajust F, Valentin JP.

J Pharmacol Toxicol Methods. 2015 Sep-Oct;75:101-10. doi: 10.1016/j.vascn.2015.01.004. Epub 2015 Jan 29.

PMID:
25637943
32.

The concordance between nonclinical and phase I clinical cardiovascular assessment from a cross-company data sharing initiative.

Ewart L, Aylott M, Deurinck M, Engwall M, Gallacher DJ, Geys H, Jarvis P, Ju H, Leishman D, Leong L, McMahon N, Mead A, Milliken P, Suter W, Teisman A, Van Ammel K, Vargas HM, Wallis R, Valentin JP.

Toxicol Sci. 2014 Dec;142(2):427-35. doi: 10.1093/toxsci/kfu198. Epub 2014 Sep 21.

PMID:
25246669
33.

Predicting changes in cardiac myocyte contractility during early drug discovery with in vitro assays.

Morton MJ, Armstrong D, Abi Gerges N, Bridgland-Taylor M, Pollard CE, Bowes J, Valentin JP.

Toxicol Appl Pharmacol. 2014 Sep 1;279(2):87-94. doi: 10.1016/j.taap.2014.06.005. Epub 2014 Jun 18.

PMID:
24952337
34.

Translational potential of a mouse in vitro bioassay in predicting gastrointestinal adverse drug reactions in Phase I clinical trials.

Keating C, Ewart L, Grundy L, Valentin JP, Grundy D.

Neurogastroenterol Motil. 2014 Jul;26(7):980-9. doi: 10.1111/nmo.12349. Epub 2014 May 11.

35.

Preservation of cardiomyocytes from the adult heart.

Abi-Gerges N, Pointon A, Pullen GF, Morton MJ, Oldman KL, Armstrong D, Valentin JP, Pollard CE.

J Mol Cell Cardiol. 2013 Nov;64:108-19. doi: 10.1016/j.yjmcc.2013.09.004. Epub 2013 Sep 16.

PMID:
24051370
36.

Safety pharmacology--current and emerging concepts.

Hamdam J, Sethu S, Smith T, Alfirevic A, Alhaidari M, Atkinson J, Ayala M, Box H, Cross M, Delaunois A, Dermody A, Govindappa K, Guillon JM, Jenkins R, Kenna G, Lemmer B, Meecham K, Olayanju A, Pestel S, Rothfuss A, Sidaway J, Sison-Young R, Smith E, Stebbings R, Tingle Y, Valentin JP, Williams A, Williams D, Park K, Goldring C.

Toxicol Appl Pharmacol. 2013 Dec 1;273(2):229-41. doi: 10.1016/j.taap.2013.04.039. Epub 2013 Jun 1. Review.

PMID:
23732082
37.

A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions.

Ewart L, Milne A, Adkins D, Benjamin A, Bialecki R, Chen Y, Ericsson AC, Gardner S, Grant C, Lengel D, Lindgren S, Lowing S, Marks L, Moors J, Oldman K, Pietras M, Prior H, Punton J, Redfern WS, Salmond R, Skinner M, Some M, Stanton A, Swedberg M, Finch J, Valentin JP.

J Pharmacol Toxicol Methods. 2013 Jul-Aug;68(1):30-43. doi: 10.1016/j.vascn.2013.04.008. Epub 2013 May 9.

PMID:
23665080
38.

A public-private consortium advances cardiac safety evaluation: achievements of the HESI Cardiac Safety Technical Committee.

Pierson JB, Berridge BR, Brooks MB, Dreher K, Koerner J, Schultze AE, Sarazan RD, Valentin JP, Vargas HM, Pettit SD.

J Pharmacol Toxicol Methods. 2013 Jul-Aug;68(1):7-12. doi: 10.1016/j.vascn.2013.03.008. Epub 2013 Apr 6.

39.

Translational pharmacokinetic-pharmacodynamic modeling of QTc effects in dog and human.

Parkinson J, Visser SA, Jarvis P, Pollard C, Valentin JP, Yates JW, Ewart L.

J Pharmacol Toxicol Methods. 2013 Nov-Dec;68(3):357-66. doi: 10.1016/j.vascn.2013.03.007. Epub 2013 Apr 6.

PMID:
23567074
40.

An evaluation of the non-invasive faecal pellet assessment method as an early drug discovery screen for gastrointestinal liability.

Marks L, Beard E, Cobey D, Moore N, Motyer V, Valentin JP, Ewart L.

J Pharmacol Toxicol Methods. 2013 Jul-Aug;68(1):123-36. doi: 10.1016/j.vascn.2013.03.006. Epub 2013 Mar 28.

PMID:
23542059
41.

Assessment of cisplatin-induced kidney injury using an integrated rodent platform.

Chen Y, Brott D, Luo W, Gangl E, Kamendi H, Barthlow H, Lengel D, Fikes J, Kinter L, Valentin JP, Bialecki R.

Toxicol Appl Pharmacol. 2013 May 1;268(3):352-61. doi: 10.1016/j.taap.2013.01.032. Epub 2013 Feb 13.

PMID:
23415679
42.

Detecting drug-induced prolongation of the QRS complex: new insights for cardiac safety assessment.

Cros C, Skinner M, Moors J, Lainee P, Valentin JP.

Toxicol Appl Pharmacol. 2012 Dec 1;265(2):200-8. doi: 10.1016/j.taap.2012.10.007. Epub 2012 Oct 13.

PMID:
23073507
43.

Refinement of the charcoal meal study by reduction of the fasting period.

Prior H, Ewart L, Bright J, Valentin JP.

Altern Lab Anim. 2012 May;40(2):99-107.

PMID:
22762194
44.

The role of the anaesthetised guinea-pig in the preclinical cardiac safety evaluation of drug candidate compounds.

Marks L, Borland S, Philp K, Ewart L, Lainée P, Skinner M, Kirk S, Valentin JP.

Toxicol Appl Pharmacol. 2012 Sep 1;263(2):171-83. doi: 10.1016/j.taap.2012.06.007. Epub 2012 Jun 17.

PMID:
22714037
45.

How do the top 12 pharmaceutical companies operate safety pharmacology?

Ewart L, Gallacher DJ, Gintant G, Guillon JM, Leishman D, Levesque P, McMahon N, Mylecraine L, Sanders M, Suter W, Wallis R, Valentin JP.

J Pharmacol Toxicol Methods. 2012 Sep;66(2):66-70. doi: 10.1016/j.vascn.2012.03.004. Epub 2012 Apr 1.

PMID:
22510338
46.

Validation of an in vitro contractility assay using canine ventricular myocytes.

Harmer AR, Abi-Gerges N, Morton MJ, Pullen GF, Valentin JP, Pollard CE.

Toxicol Appl Pharmacol. 2012 Apr 15;260(2):162-72. doi: 10.1016/j.taap.2012.02.007. Epub 2012 Feb 21.

PMID:
22373797
47.

An in silico canine cardiac midmyocardial action potential duration model as a tool for early drug safety assessment.

Davies MR, Mistry HB, Hussein L, Pollard CE, Valentin JP, Swinton J, Abi-Gerges N.

Am J Physiol Heart Circ Physiol. 2012 Apr 1;302(7):H1466-80. doi: 10.1152/ajpheart.00808.2011. Epub 2011 Dec 23. Erratum in: Am J Physiol Heart Circ Physiol. 2012 Aug 15;303(4):H497-8.

48.

Application of data mining and visualization techniques for the prediction of drug-induced nausea in man.

Parkinson J, Muthas D, Clark M, Boyer S, Valentin JP, Ewart L.

Toxicol Sci. 2012 Mar;126(1):275-84. doi: 10.1093/toxsci/kfr334. Epub 2011 Dec 9.

PMID:
22157355
49.

Measurement of action potential generation in isolated canine left ventricular midmyocardial myocytes.

Johnson DM, Hussein L, Spätjens RL, Valentin JP, Volders PG, Abi-Gerges N.

Curr Protoc Pharmacol. 2011 Dec;Chapter 10:Unit 10.14.1-23. doi: 10.1002/0471141755.ph1014s55.

PMID:
22147346
50.

Safety pharmacology in 2010 and beyond: survey of significant events of the past 10 years and a roadmap to the immediate-, intermediate- and long-term future in recognition of the tenth anniversary of the Safety Pharmacology Society.

Bass AS, Vargas HM, Valentin JP, Kinter LB, Hammond T, Wallis R, Siegl PK, Yamamoto K.

J Pharmacol Toxicol Methods. 2011 Jul-Aug;64(1):7-15. doi: 10.1016/j.vascn.2011.05.006. Epub 2011 Jun 12. Review.

PMID:
21689769

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