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Items: 20

1.

Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a provisional safety margin in drug development.

Redfern WS, Carlsson L, Davis AS, Lynch WG, MacKenzie I, Palethorpe S, Siegl PK, Strang I, Sullivan AT, Wallis R, Camm AJ, Hammond TG.

Cardiovasc Res. 2003 Apr 1;58(1):32-45. Review.

PMID:
12667944
2.

The safety risks of innovation: the FDA's Expedited Drug Development Pathway.

Moore TJ, Furberg CD.

JAMA. 2012 Sep 5;308(9):869-70. doi: 10.1001/jama.2012.9658. No abstract available.

PMID:
22948694
3.

The discovery and development of proteomic safety biomarkers for the detection of drug-induced liver toxicity.

Amacher DE.

Toxicol Appl Pharmacol. 2010 May 15;245(1):134-42. doi: 10.1016/j.taap.2010.02.011. Review.

PMID:
20219512
4.

Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a consensus statement.

Meyer RE, Salzman C, Youngstrom EA, Clayton PJ, Goodwin FK, Mann JJ, Alphs LD, Broich K, Goodman WK, Greden JF, Meltzer HY, Normand SL, Posner K, Shaffer D, Oquendo MA, Stanley B, Trivedi MH, Turecki G, Beasley CM Jr, Beautrais AL, Bridge JA, Brown GK, Revicki DA, Ryan ND, Sheehan DV.

J Clin Psychiatry. 2010 Aug;71(8):e1-e21. doi: 10.4088/JCP.10cs06070blu.

PMID:
20797373
5.

Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a brief report.

Meyer RE, Salzman C, Youngstrom EA, Clayton PJ, Goodwin FK, Mann JJ, Alphs LD, Broich K, Goodman WK, Greden JF, Meltzer HY, Normand SL, Posner K, Shaffer D, Oquendo MA, Stanley B, Trivedi MH, Turecki G, Beasley CM Jr, Beautrais AL, Bridge JA, Brown GK, Revicki DA, Ryan ND, Sheehan DV.

J Clin Psychiatry. 2010 Aug;71(8):1040-6. doi: 10.4088/JCP.10cs06070ablu.

PMID:
20673551
6.

Drug safety is a barrier to the discovery and development of new androgen receptor antagonists.

Foster WR, Car BD, Shi H, Levesque PC, Obermeier MT, Gan J, Arezzo JC, Powlin SS, Dinchuk JE, Balog A, Salvati ME, Attar RM, Gottardis MM.

Prostate. 2011 Apr;71(5):480-8. doi: 10.1002/pros.21263.

PMID:
20878947
7.

Development of recombinant cell line co-expressing mutated Nav1.5, Kir2.1, and hERG for the safety assay of drug candidates.

Fujii M, Ohya S, Yamamura H, Imaizumi Y.

J Biomol Screen. 2012 Jul;17(6):773-84. doi: 10.1177/1087057112442102.

PMID:
22498908
8.

Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team.

Crowe BJ, Xia HA, Berlin JA, Watson DJ, Shi H, Lin SL, Kuebler J, Schriver RC, Santanello NC, Rochester G, Porter JB, Oster M, Mehrotra DV, Li Z, King EC, Harpur ES, Hall DB.

Clin Trials. 2009 Oct;6(5):430-40. doi: 10.1177/1740774509344101.

PMID:
19846894
9.

Development of a context model to prioritize drug safety alerts in CPOE systems.

Riedmann D, Jung M, Hackl WO, Stühlinger W, van der Sijs H, Ammenwerth E.

BMC Med Inform Decis Mak. 2011 May 25;11:35. doi: 10.1186/1472-6947-11-35.

10.

Model-based meta-analysis for comparative efficacy and safety: application in drug development and beyond.

Mandema JW, Gibbs M, Boyd RA, Wada DR, Pfister M.

Clin Pharmacol Ther. 2011 Dec;90(6):766-9. doi: 10.1038/clpt.2011.242.

PMID:
22089340
12.

Troponin measurements during drug development--considerations for monitoring and management of potential cardiotoxicity: an educational collaboration among the Cardiac Safety Research Consortium, the Duke Clinical Research Institute, and the US Food and Drug Administration.

Newby LK, Rodriguez I, Finkle J, Becker RC, Hicks KA, Hausner E, Chesler R, Harper C, Targum S, Berridge BR, Lewis E, Walker DB, Dollery C, Turner JR, Krucoff MW.

Am Heart J. 2011 Jul;162(1):64-73. doi: 10.1016/j.ahj.2011.04.005. Review.

PMID:
21742091
13.

Pediatric cardiovascular safety: challenges in drug and device development and clinical application.

Bates KE, Vetter VL, Li JS, Cummins S, Aguel F, Almond C, Dubin AM, Elia J, Finkle J, Hausner EA, Joseph F, Karkowsky AM, Killeen M, Lemacks J, Mathis L, McMahon AW, Pinnow E, Rodriguez I, Stockbridge NL, Stockwell M, Tassinari M, Krucoff MW.

Am Heart J. 2012 Oct;164(4):481-92. doi: 10.1016/j.ahj.2012.07.019.

PMID:
23067905
14.

Clinical pharmacology: special safety considerations in drug development and pharmacovigilance.

Atuah KN, Hughes D, Pirmohamed M.

Drug Saf. 2004;27(8):535-54. Review.

PMID:
15154826
15.

Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: strategy, challenges, current practices.

Morford LL, Bowman CJ, Blanset DL, Bøgh IB, Chellman GJ, Halpern WG, Weinbauer GF, Coogan TP.

Birth Defects Res B Dev Reprod Toxicol. 2011 Aug;92(4):359-80. doi: 10.1002/bdrb.20305. Review.

PMID:
21770023
16.

Factors to consider in the use of stem cells for pharmaceutic drug development and for chemical safety assessment.

Trosko JE, Chang CC.

Toxicology. 2010 Mar 30;270(1):18-34. doi: 10.1016/j.tox.2009.11.019. Review.

PMID:
19948204
17.

Exploratory drug safety: a discovery strategy to reduce attrition in development.

Bass AS, Cartwright ME, Mahon C, Morrison R, Snyder R, McNamara P, Bradley P, Zhou YY, Hunter J.

J Pharmacol Toxicol Methods. 2009 Jul-Aug;60(1):69-78. doi: 10.1016/j.vascn.2009.04.194. Review.

PMID:
19422924
18.

Impact of biomarker development on drug safety assessment.

Marrer E, Dieterle F.

Toxicol Appl Pharmacol. 2010 Mar 1;243(2):167-79. doi: 10.1016/j.taap.2009.12.015. Review.

PMID:
20036272
19.

An integrated reactive metabolite evaluation approach to assess and reduce safety risk during drug discovery and development.

Reese M, Sakatis M, Ambroso J, Harrell A, Yang E, Chen L, Taylor M, Baines I, Zhu L, Ayrton A, Clarke S.

Chem Biol Interact. 2011 Jun 30;192(1-2):60-4. doi: 10.1016/j.cbi.2010.10.005.

PMID:
20970409
20.

Drug induced shortening of the QT/QTc interval: an emerging safety issue warranting further modelling and evaluation in drug research and development?

Holbrook M, Malik M, Shah RR, Valentin JP.

J Pharmacol Toxicol Methods. 2009 Jan-Feb;59(1):21-8. doi: 10.1016/j.vascn.2008.09.001.

PMID:
18834945

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