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farmacologia di sicurezza

English translation: drug safety studies

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Italian term or phrase:farmacologia di sicurezza
English translation:drug safety studies
Entered by: maryan70
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18:22 Dec 20, 2003
Italian to English translations [PRO]
Medical
Italian term or phrase: farmacologia di sicurezza
sulla base di studi convenzionali di farmacologia di sicurezza, tossicità per somministrazioni ripetute, genotossicità, potenziale cancerogeno, tossicità riproduttiva.
maryan70
Italy
Local time: 10:37
drug 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]
Selected response from:

Gilberto Lacchia
Italy
Local time: 10:37
Grading comment
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +2safety pharmacologyScience451
3 +1drug safety
Gilberto Lacchia
4pharmacologic safety
Jennifer Baker
3pharmacological safety
Robert Tucker
2security pharmacologysmarinella


  

Answers


8 mins   confidence: Answerer confidence 2/5Answerer confidence 2/5
security pharmacology


Explanation:
never heard, to be honest, but anyway...



smarinella
Italy
Local time: 10:37
Native speaker of: Native in ItalianItalian
PRO pts in pair: 46
Login to enter a peer comment (or grade)

8 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
pharmacologic safety


Explanation:
I would turn it around and put it this way.

Jennifer Baker
United States
Local time: 02:37
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 231
Login to enter a peer comment (or grade)

30 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
drug 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=...
Gilberto Lacchia
Italy
Local time: 10:37
Native speaker of: Italian
PRO pts in pair: 1841

Peer comments on this answer (and responses from the answerer)
agree  Jose Paez
7 hrs
Login to enter a peer comment (or grade)

3 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
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
Robert Tucker
United Kingdom
Local time: 09:37
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 325
Login to enter a peer comment (or grade)

3 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
safety 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
Science451
Italy
Local time: 10:37
Native speaker of: Native in ItalianItalian
PRO pts in pair: 1132

Peer comments on this answer (and responses from the answerer)
agree  Giulia Barontini
3 hrs
  -> grazie :)

agree  texjax DDS PhD: Meglio tardi che mai! :)) / Come stai? Tutto bene?
4527 days
  -> grazie ! :) Tutto bene, texjax :) Tu sempre in US , suppongo
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