farmacologia di sicurezza
English translation: drug safety studies
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| 18:22 Dec 20, 2003 |
| Italian to English translations [PRO] Medical | |||||||
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|  Selected response from: Gilberto Lacchia Italy Local time: 19:17 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 4 +2 | safety pharmacology |
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| 4 | pharmacologic safety |
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| 3 +1 | drug safety |
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| 3 | pharmacological safety |
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| 2 | security pharmacology |
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Answers
8 mins confidence: 
security pharmacology Explanation: never heard, to be honest, but anyway... |
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8 mins confidence:
pharmacologic safety Explanation: I would turn it around and put it this way. |
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30 mins confidence: peer agreement (net): +1
peer agreement (net): +1drug safety Explanation: Just a suggestion: "drug safety studies". 1: Castle AL, Carver MP, Mendrick DL. Related Articles, Links Toxicogenomics: a new revolution in drug safety. Drug Discov Today. 2002 Jul 1;7(13):728-36. Review. PMID: 12110229 [PubMed - indexed for MEDLINE] 2: Ozdemir V, Shear NH, Kalow W. Related Articles, Links What will be the role of pharmacogenetics in evaluating drug safety and minimising adverse effects? Drug Saf. 2001;24(2):75-85. Review. PMID: 11235820 [PubMed - indexed for MEDLINE] 3: Waring JF, Ulrich RG. Related Articles, Links The impact of genomics-based technologies on drug safety evaluation. Annu Rev Pharmacol Toxicol. 2000;40:335-52. Review. PMID: 10836140 [PubMed - indexed for MEDLINE] 4: Finney DJ. Related Articles, Links Postmarketing studies: the work of the Drug Safety Research Unit. Drug Saf. 1999 Oct;21(4):337-8. No abstract available. PMID: 10514024 [PubMed - indexed for MEDLINE] 5: Shah RR, Midgley JM, Branch SK. Related Articles, Links Stereochemical origin of some clinically significant drug safety concerns: lessons for future drug development. Adverse Drug React Toxicol Rev. 1998 Jun-Sep;17(2-3):145-90. Review. No abstract available. PMID: 9838970 [PubMed - indexed for MEDLINE] 6: Jick H. Related Articles, Links Drug-associated asymptomatic elevations of transaminase in drug safety assessments. Pharmacotherapy. 1995 Jan-Feb;15(1):23-5. No abstract available. PMID: 7739941 [PubMed - indexed for MEDLINE] 7: Smith DA. Related Articles, Links Integration of animal pharmacokinetic and pharmacodynamic data in drug safety assessment. Eur J Drug Metab Pharmacokinet. 1993 Jan-Mar;18(1):31-9. Review. PMID: 8335037 [PubMed - indexed for MEDLINE] 8: Caprino L. Related Articles, Links Evaluation of drug safety by toxicological test procedures as provided by regulatory laws: an overview. Pharmacol Res. 1990 May-Jun;22(3):253-62. Review. No abstract available. PMID: 2195487 [PubMed - indexed for MEDLINE] 9: [No authors listed] Related Articles, Links Pharmacoepidemiology and drug safety. Pharmacoepidemiol Drug Saf. 2003 Jun;12(4):341-56. No abstract available. PMID: 12812015 [PubMed - indexed for MEDLINE] Reference: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=Search&DB=... |
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3 hrs confidence:
pharmacological safety Explanation: ...gli esseri umani in base agli studi convenzionali sulla sicurezza farmacologica, tossicità a dosi ripetute, genotossicità, potenziale carcinogenico e tossicità nella riproduzione, .... This just slightly different wording appears in the reference. Reference: http://www.vitadidonna.it/copia_di_vita_di_000066.html |
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3 hrs confidence: peer agreement (net): +2
peer agreement (net): +2safety pharmacology Explanation: E. Definition of **Safety Pharmacology** (1.5) Pharmacology studies can be divided into three categories: primary pharmacodynamic, secondary pharmacodynamic, and safety pharmacology studies. For the purpose of this document, safety pharmacology studies are defined as those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above. (See Note 2 for definitions of primary pharmacodynamic and secondary pharmacodynamic studies.) In some cases, information on the primary and secondary pharmacodynamic properties of the substance contributes to the safety evaluation for potential adverse effects in humans and should be considered along with the findings of safety pharmacology studies. Reference: http://www.fda.gov/cder/guidance/4461fnl.htm |
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