-
1
-
-
1242329171
-
Application of data mining techniques in pharmacovigilance
-
Wilson MA, Thabane L, Holbrook A. Application of data mining techniques in pharmacovigilance. Br J Clin Pharmacol 2003; 57: 127-134.
-
(2003)
Br J Clin Pharmacol
, vol.57
, pp. 127-134
-
-
Wilson, M.A.1
Thabane, L.2
Holbrook, A.3
-
2
-
-
40849130153
-
The risk we bear: the effects of review speed and industry user fees on new drug safety
-
Olson M. The risk we bear: the effects of review speed and industry user fees on new drug safety. J Health Econ 2008; 27: 175-200.
-
(2008)
J Health Econ
, vol.27
, pp. 175-200
-
-
Olson, M.1
-
3
-
-
8844256592
-
Are novel drugs more risky for patients than less novel drugs?
-
Olson M. Are novel drugs more risky for patients than less novel drugs? J Health Econ 2004; 23: 1135-1158.
-
(2004)
J Health Econ
, vol.23
, pp. 1135-1158
-
-
Olson, M.1
-
4
-
-
45549100121
-
Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy
-
Motola D, Vargiu A, Leone R, et al. Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy. Drug Saf 2008; 31: 609-616.
-
(2008)
Drug Saf
, vol.31
, pp. 609-616
-
-
Motola, D.1
Vargiu, A.2
Leone, R.3
-
5
-
-
52549103374
-
Structure and process in spontaneous ADR reporting systems: a comparative study of Australia and Denmark
-
Aagaard L, Stenver DI, Hansen EH. Structure and process in spontaneous ADR reporting systems: a comparative study of Australia and Denmark. Pharm World Sci 2008; 30: 563-570.
-
(2008)
Pharm World Sci
, vol.30
, pp. 563-570
-
-
Aagaard, L.1
Stenver, D.I.2
Hansen, E.H.3
-
6
-
-
35349014324
-
Adverse drug reaction reporting in New Zealand: implications for pharmacists
-
Zolezzi M, Parsotam N. Adverse drug reaction reporting in New Zealand: implications for pharmacists. Ther Clin Risk Manag 2005; 2: 181-188.
-
(2005)
Ther Clin Risk Manag
, vol.2
, pp. 181-188
-
-
Zolezzi, M.1
Parsotam, N.2
-
7
-
-
77955570230
-
Adverse drug reaction reporting in the UK: A Retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals
-
McLernon D, Bond C, Hannaford P, Watson M, et al. Adverse drug reaction reporting in the UK: A Retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals. Drug Saf 2010; 33: 775-788.
-
(2010)
Drug Saf
, vol.33
, pp. 775-788
-
-
McLernon, D.1
Bond, C.2
Hannaford, P.3
Watson, M.4
-
8
-
-
33646744337
-
Under-reporting of adverse drug reactions. A systematic review
-
Hazell L, Shakir SAW. Under-reporting of adverse drug reactions. A systematic review. Drug Saf 2006; 29: 385-396.
-
(2006)
Drug Saf
, vol.29
, pp. 385-396
-
-
Hazell, L.1
Shakir, S.A.W.2
-
9
-
-
75749100539
-
Delays in new drug applications in Japan and industrial R&D strategies
-
Hirai Y, Kinoshita H, Kusama M, Yasuda K, Sugiyama Y, Ono S. Delays in new drug applications in Japan and industrial R&D strategies. Clin Pharmacol Ther 2010; 87: 212-218.
-
(2010)
Clin Pharmacol Ther
, vol.87
, pp. 212-218
-
-
Hirai, Y.1
Kinoshita, H.2
Kusama, M.3
Yasuda, K.4
Sugiyama, Y.5
Ono, S.6
-
10
-
-
39849104302
-
Approval of new biopharmaceuticals 1999-2006: comparison of the US, EU and Japan situations
-
Tsuji K, Tsutani K. Approval of new biopharmaceuticals 1999-2006: comparison of the US, EU and Japan situations. Eur J Pharm Biopharm 2008; 68: 496-502.
-
(2008)
Eur J Pharm Biopharm
, vol.68
, pp. 496-502
-
-
Tsuji, K.1
Tsutani, K.2
-
11
-
-
49949087028
-
Is this the drug or dose for you?: Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice
-
Huang S-M, Temple R. Is this the drug or dose for you?: Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice. Clin Pharmacol Ther 2008; 82: 287-294.
-
(2008)
Clin Pharmacol Ther
, vol.82
, pp. 287-294
-
-
Huang, S.-M.1
Temple, R.2
-
12
-
-
84877589322
-
-
FDA. Guidance for industry. Collection of race and ethnicity data in clinical trials. FDA CDER/CBER/CDRH/OC, Rockville; September [4 October 2012]
-
FDA. Guidance for industry. Collection of race and ethnicity data in clinical trials. FDA CDER/CBER/CDRH/OC, Rockville; September 2005. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126396.pdf [4 October 2012].
-
(2005)
-
-
-
13
-
-
84877601067
-
-
FDA. Drug safety communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer. FDA, Silver Spring; Jun [4 October 2012]
-
FDA. Drug safety communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer. FDA, Silver Spring; Jun 2011.http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm [4 October 2012].
-
(2011)
-
-
-
14
-
-
84877615674
-
-
EMA. Update on ongoing European review of pioglitazone-containing medicines. EMA, London; Jun [4 October 2012]
-
EMA. Update on ongoing European review of pioglitazone-containing medicines. EMA, London; Jun 2011. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/06/news_detail_001275.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1&jsenabled=true [4 October 2012].
-
(2011)
-
-
-
15
-
-
84877622457
-
-
PMDA. Search site for reported serious ADRs (in Japanese). PMDA, Tokyo [4 October 2012]
-
PMDA. Search site for reported serious ADRs (in Japanese). PMDA, Tokyo; http://www.info.pmda.go.jp/fukusayou/menu_fukusayou_attention.html [4 October 2012].
-
-
-
-
16
-
-
0036570099
-
Timing of new black box warnings and withdrawals for prescription medications
-
Lasser K, Allen P, Woolhandler S, et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002; 287: 2215-2220.
-
(2002)
JAMA
, vol.287
, pp. 2215-2220
-
-
Lasser, K.1
Allen, P.2
Woolhandler, S.3
-
17
-
-
84877602167
-
-
FDA. The clinical impact of adverse event reporting; A MedWatch continuing education article. FDA/CDER, Rockville [4 October 2012]
-
FDA. The clinical impact of adverse event reporting; A MedWatch continuing education article. FDA/CDER, Rockville; 1996. http://www.fda.gov/downloads/Safety/MedWatch/UCM168505.pdf [4 October 2012].
-
(1996)
-
-
-
18
-
-
78649919557
-
Analysis of pharmaceutical safety-related regulatory actions in Japan: Do tradeoffs exist between safer drugs and launch delay?
-
Yamada T, Kusama M, Hirai Y, Arnold FL, Sugiyama Y, Ono S. Analysis of pharmaceutical safety-related regulatory actions in Japan: Do tradeoffs exist between safer drugs and launch delay? Ann Pharmacother 2010; 44: 1976-1985.
-
(2010)
Ann Pharmacother
, vol.44
, pp. 1976-1985
-
-
Yamada, T.1
Kusama, M.2
Hirai, Y.3
Arnold, F.L.4
Sugiyama, Y.5
Ono, S.6
-
19
-
-
84877599729
-
-
MHLW. Q & A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing Phase Vigilance (EPPV) for prescription drugs. MHLW/PFSB/Safety Division, Tokyo; September [4 October 2012]
-
MHLW. Q & A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing Phase Vigilance (EPPV) for prescription drugs. MHLW/PFSB/Safety Division, Tokyo; September 2009. http://www.pmda.go.jp/english/service/pdf/notifications/20090907.pdf [4 October 2012].
-
(2009)
-
-
-
20
-
-
84877594131
-
-
FDA. Guidance medication guides - distribution requirements and inclusion in risk evaluation and mitigation strategies (REMS). FDA/CDER/CBER, Silver Spring; November [4 October 2012]
-
FDA. Guidance medication guides - distribution requirements and inclusion in risk evaluation and mitigation strategies (REMS). FDA/CDER/CBER, Silver Spring; November 2011. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM244570.pdf [4 October 2012].
-
(2011)
-
-
-
21
-
-
10444224997
-
Strategic detailing and pricing behaviour in international markets
-
Chintagunta P, Desiraju R. Strategic detailing and pricing behaviour in international markets. Marketing Sci 2005; 24: 67-80.
-
(2005)
Marketing Sci
, vol.24
, pp. 67-80
-
-
Chintagunta, P.1
Desiraju, R.2
-
22
-
-
33845722633
-
The antibiotic prescribing behavior of physicians for acute tonsillopharyngitis in primary care
-
Canli H, Saatci E, Bozdemir N, Akpinar E, Kiroglu M. The antibiotic prescribing behavior of physicians for acute tonsillopharyngitis in primary care. Ethiop Med J 2006; 44: 139-143.
-
(2006)
Ethiop Med J
, vol.44
, pp. 139-143
-
-
Canli, H.1
Saatci, E.2
Bozdemir, N.3
Akpinar, E.4
Kiroglu, M.5
-
23
-
-
34247486946
-
Characteristics and impact of drug detailing for gabapentin
-
doi:10.1371/journal.pmed.0040134
-
Steinman MA, Harper GM, Chren MM, et al. Characteristics and impact of drug detailing for gabapentin. PLoS Med 2007; 4: e134. doi:10.1371/journal.pmed.0040134
-
(2007)
PLoS Med
, vol.4
-
-
Steinman, M.A.1
Harper, G.M.2
Chren, M.M.3
|