Secondary pharmacology data to assess potential off-target activity of new drugs: A regulatory perspective

Nature Reviews Drug Discovery

Volumn 14, Issue 4, 2015, Pages 294-

  Papoian, Thomas ^a   Chiu, Haw Jyh ^a   Elayan, Ikram ^a   Jagadeesh, Gowraganahalli ^a   Khan, Imran ^a   Laniyonu, Adebayo A ^a   Li, Cindy Xinguang ^a   Saulnier, Muriel ^a   Simpson, Natalie ^a   Yang, Baichun ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ADVERSE DRUG REACTION; ARTICLE; CLINICAL PHARMACOLOGY; CLINICAL PROTOCOL; COST EFFECTIVENESS ANALYSIS; DRUG ACTIVITY; DRUG DETERMINATION; DRUG DEVELOPMENT; DRUG MONITORING; DRUG OFF TARGET ACTIVITY; DRUG POTENCY; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; DRUG TARGETING; PRIORITY JOURNAL; SECONDARY PHARMACOLOGY; STRUCTURE ACTIVITY RELATION; ANIMAL; COST BENEFIT ANALYSIS; DRUG LEGISLATION; HUMAN; OFF LABEL DRUG USE; TRENDS;

ANIMALS; COST-BENEFIT ANALYSIS; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; LEGISLATION, DRUG; OFF-LABEL USE; PHARMACOLOGY, CLINICAL; STRUCTURE-ACTIVITY RELATIONSHIP;

EID: 84926422121     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd3845-c1     Document Type: Article

References (10)

1. Bowes J., et al. Reducing safety-related drug attrition: the use of in vitro pharmacological profiling. Nature Rev. Drug Discov. 11, 909-922 (2012
2. ICH Expert Working Group. Safety pharmacology studies for human pharmaceuticals S7A. ICH [online], http://www.ich.org/fileadmin/Public-Web-Site/ICH- Products/Guidelines/Safety/S7A/Step4/S7A-Guideline. pdf (2001
3. Bass A. S., et al. Exploratory drug safety: a discovery strategy to reduce attrition in development. J. Pharmacol. Toxicol. Methods 60, 69-78 (2009
4. Hughes J. P., et al. Principles of early drug discovery. Br. J. Pharmacol. 162, 1239-1249 (2011
5. Lounkine E., et al. Large-scale prediction and testing of drug activity on side-effect targets. Nature 486, 361-367 (2012
6. Muller P. Y. & Milton M. N. The determination and interpretation of the therapeutic index in drug development. Nature Rev. Drug Discov. 11, 751-761 (2012
7. Redfern W. S., et al. Safety pharmacology - a progressive approach. Fundam. Clin. Pharmacol. 16, 161-173 (2002
8. Valentin J. P. & Hammond T. Safety and secondary pharmacology: successes threats challenges and opportunities. J. Pharmacol. Toxicol. Methods 58, 77-87 (2008
9. Wakefield I. D., et al. The application of in vitro methods to safety pharmacology. Fundam. Clin. Pharmacol. 16, 209-218 (2002
10. Whitebread S., et al. In vitro safety pharmacology profiling: an essential tool for successful drug development. Drug Discov. Today 10, 1421-1433 (2005