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Results: 1 to 20 of 134

1.

Safety information in drug labeling: a comparison of the USA, the UK, and Japan.

Shimazawa R, Ikeda M.

Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):306-18. doi: 10.1002/pds.3408. Epub 2013 Jan 28.

PMID:
23355452
[PubMed - indexed for MEDLINE]
2.

Consistency in the safety labeling of bioequivalent medications.

Duke J, Friedlin J, Li X.

Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):294-301. doi: 10.1002/pds.3351. Epub 2012 Oct 8.

PMID:
23042584
[PubMed - indexed for MEDLINE]
3.

Evaluation of FDA safety-related drug label changes in 2010.

Lester J, Neyarapally GA, Lipowski E, Graham CF, Hall M, Dal Pan G.

Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):302-5. doi: 10.1002/pds.3395. Epub 2013 Jan 2.

PMID:
23280652
[PubMed - indexed for MEDLINE]
4.

European Medicines Agency assesses safety reporting at Roche.

Marshall H.

Lancet Oncol. 2012 Aug;13(8):e331. No abstract available.

PMID:
23024993
[PubMed - indexed for MEDLINE]
5.

Different indications, warnings and precautions, and contraindications for the same drug--an international comparison of prescribing information for commonly used psychiatric drugs.

Pfistermeister B, Schenk C, Kornhuber J, B├╝rkle T, Fromm MF, Maas R.

Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):329-33. doi: 10.1002/pds.3389. Epub 2012 Dec 26.

PMID:
23280570
[PubMed - indexed for MEDLINE]
6.

Red sky in the morning: modifying prescription drug labels as a result of postmarket surveillance.

Jacobson JD, Feigal D.

Food Drug Law J. 2007;62(3):529-46. No abstract available.

PMID:
17915395
[PubMed - indexed for MEDLINE]
7.

Similarities and differences between US and Japan as to pharmacogenomic biomarker information in drug labels.

Otsubo Y, Asahina Y, Noguchi A, Sato Y, Ando Y, Uyama Y.

Drug Metab Pharmacokinet. 2012;27(1):142-9. Epub 2011 Dec 27.

PMID:
22201121
[PubMed - indexed for MEDLINE]
Free Article
8.

Comparison of information on the pharmacokinetic interactions of Ca antagonists in the package inserts from three countries (Japan, USA and UK).

Saito M, Hirata-Koizumi M, Miyake S, Hasegawa R.

Eur J Clin Pharmacol. 2005 Aug;61(7):531-6. Epub 2005 Jul 23.

PMID:
16041596
[PubMed - indexed for MEDLINE]
9.

Evaluation of adverse drug event information in US manufacturer labels.

Harrington CA, Garcia AS, Sircar-Ramsewak F.

Curr Drug Saf. 2011 Feb 1;6(1):30-5.

PMID:
21047299
[PubMed - indexed for MEDLINE]
10.

Bringing greater transparency to "black box" warnings.

Buckley NA, Rossi S.

Clin Toxicol (Phila). 2011 Jul;49(6):448-51. doi: 10.3109/15563650.2011.593523.

PMID:
21824055
[PubMed - indexed for MEDLINE]
11.
12.

Mining FDA drug labels using an unsupervised learning technique--topic modeling.

Bisgin H, Liu Z, Fang H, Xu X, Tong W.

BMC Bioinformatics. 2011 Oct 18;12 Suppl 10:S11. doi: 10.1186/1471-2105-12-S10-S11.

PMID:
22166012
[PubMed - indexed for MEDLINE]
Free PMC Article
13.
14.

Boxed warning inconsistencies between drug information resources and the prescribing information.

Cheng CM, Fu C, Guglielmo BJ, Auerbach AD.

Am J Health Syst Pharm. 2011 Sep 1;68(17):1626-31. doi: 10.2146/ajhp110025.

PMID:
21856808
[PubMed - indexed for MEDLINE]
15.

Investigating drug repositioning opportunities in FDA drug labels through topic modeling.

Bisgin H, Liu Z, Kelly R, Fang H, Xu X, Tong W.

BMC Bioinformatics. 2012;13 Suppl 15:S6. doi: 10.1186/1471-2105-13-S15-S6. Epub 2012 Sep 11.

PMID:
23046522
[PubMed - indexed for MEDLINE]
Free PMC Article
16.

Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom and Japan.

Shimazawa R, Ikeda M.

J Clin Pharm Ther. 2013 Dec;38(6):468-75. doi: 10.1111/jcpt.12089. Epub 2013 Jul 29.

PMID:
23895776
[PubMed - in process]
17.

A review of pharmaceutical labeling for overdose treatment and toxicity data.

Mazer-Amirshahi M, Sokol G, van den Anker J, Cantilena L.

Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):319-23. doi: 10.1002/pds.3398. Epub 2013 Jan 2.

PMID:
23283832
[PubMed - indexed for MEDLINE]
18.

Provision of information on regulatory authorities' websites.

Vitry A, Lexchin J, Sasich L, Dupin-Spriet T, Reed T, Bertele V, Garattini S, Toop L, Hurley E.

Intern Med J. 2008 Jul;38(7):559-67. doi: 10.1111/j.1445-5994.2007.01588.x. Epub 2008 Mar 11.

PMID:
18336542
[PubMed - indexed for MEDLINE]
19.

Contraindication labelling changes in the United States and Germany.

Garbe E, Andersohn F.

Eur J Clin Pharmacol. 2007 Jan;63(1):87-93. Epub 2006 Nov 24.

PMID:
17124576
[PubMed - indexed for MEDLINE]
20.

Drug safety on trial.

[No authors listed]

Nature. 2005 Mar 31;434(7033):545. No abstract available.

PMID:
15800579
[PubMed - indexed for MEDLINE]

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