-
1
-
-
79751528864
-
-
AstraZeneca, Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee Meeting. Available at
-
AstraZeneca. 2010. Briefing Document for Cardiovascular and Renal Drugs Advisory Committee Meeting. Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee Meeting. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM220197.pdf
-
(2010)
Briefing Document for Cardiovascular and Renal Drugs Advisory Committee Meeting
-
-
-
2
-
-
84880968388
-
Brilinta, Product Label," Food and Drug Administration
-
Center for Drug Evaluation and Research, Available at
-
Center for Drug Evaluation and Research. 2011a. "Brilinta, Product Label," Food and Drug Administration. Available at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000Lbl.pdf
-
(2011)
-
-
-
3
-
-
84880999910
-
Brilinta, Summary Review," Food and Drug Administration
-
Center for Drug Evaluation and Research, Available at
-
Center for Drug Evaluation and Research. 2011b. "Brilinta, Summary Review," Food and Drug Administration. Available at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000SumR.pdf
-
(2011)
-
-
-
4
-
-
84880999910
-
Brilinta, Statistical Review," Food and Drug Administration
-
Center for Drug Evaluation and Research, Available at
-
Center for Drug Evaluation and Research. 2011c. "Brilinta, Statistical Review," Food and Drug Administration. Available at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000StatR.pdf
-
(2011)
-
-
-
5
-
-
84880992163
-
ICH E5 Ethnic Factors in the Acceptability of Foreign Clinical Data," European Medicines Agency
-
European Medicines Agency, Available at
-
European Medicines Agency. 1998. "ICH E5 Ethnic Factors in the Acceptability of Foreign Clinical Data," European Medicines Agency. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002842.pdf
-
(1998)
-
-
-
6
-
-
0028858130
-
Interpretation of Subgroup Analyses in Clinical Trials
-
Fleming, T. R. 1995. Interpretation of Subgroup Analyses in Clinical Trials. Drug Information Journal, 29: 1681S - 1687S.
-
(1995)
Drug Information Journal
, vol.29
-
-
Fleming, T.R.1
-
7
-
-
77957326656
-
Clinical Trials: Discerning Hype from Substance
-
Fleming, T. R. 2010. Clinical Trials: Discerning Hype from Substance. Annals of Internal Medicine, 153: 400 - 406.
-
(2010)
Annals of Internal Medicine
, vol.153
, pp. 400-406
-
-
Fleming, T.R.1
-
9
-
-
80051550924
-
Ticagrelor Compared With Clopidogrel by Geographic Region in the Platelet Inhibition and Patient Outcomes (PLATO) Trial
-
Mahaffey, K. W. 2011. Ticagrelor Compared With Clopidogrel by Geographic Region in the Platelet Inhibition and Patient Outcomes (PLATO) Trial. Circulation, 124: 544 - 554.
-
(2011)
Circulation
, vol.124
, pp. 544-554
-
-
Mahaffey, K.W.1
-
10
-
-
70449660319
-
Basic Principles on Global Clinical Trials
-
Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau, Director of Evaluation and Licensing Division, available at
-
Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau, Director of Evaluation and Licensing Division. 2007. Basic Principles on Global Clinical Trials. available at www.pmda.go.jp/operations/notice/2007/file/0928010-e.pdf
-
(2007)
-
-
-
11
-
-
84881009870
-
Statistical Issues in Multiple-Regional Clinical Trials. FDA/Industry Statistics Workshop
-
available at
-
O'Neill, R. 2009. Statistical Issues in Multiple-Regional Clinical Trials. FDA/Industry Statistics Workshop. available at http://www.amstat.org/meetings/fdaworkshop/index.cfm?fuseaction=AbstractDetails&AbstractID=300578
-
(2009)
-
-
O'Neill, R.1
-
12
-
-
84876454031
-
Empirical Shrinkage Estimator for Consistency Assessment of Treatment Effects in Multiregional Clinical Trials. Statistics in Medicine
-
published online August 1. Available at
-
Quan, H. 2012. Empirical Shrinkage Estimator for Consistency Assessment of Treatment Effects in Multiregional Clinical Trials. Statistics in Medicine. published online August 1. Available at http://onlinelibrary.wiley.com/doi/10.1002/sim.5543/pdf
-
(2012)
-
-
Quan, H.1
-
14
-
-
0037108041
-
Bayesian Subset Analysis: Application to Studying Treatment-by-Gender Interactions
-
Simon, R. 2002. Bayesian Subset Analysis: Application to Studying Treatment-by-Gender Interactions. Statistics in Medicine, 21: 2909 - 2916.
-
(2002)
Statistics in Medicine
, vol.21
, pp. 2909-2916
-
-
Simon, R.1
-
15
-
-
72249116214
-
Guidance for Industry Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, available at
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. 2008. Guidance for Industry Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. available at http://www.fda.gov/downloads/Drugs/GuidanceCom plianceRegulatoryInformation/Guidances/UCM071627.pdf
-
(2008)
-
-
-
16
-
-
70149101223
-
Ticagrelor Versus Clopidogrel in Patients With Acute Coronary Syndromes
-
Wallentin, L. 2009a. Ticagrelor Versus Clopidogrel in Patients With Acute Coronary Syndromes. New England Journal of Medicine, 361: 1045 - 1057.
-
(2009)
New England Journal of Medicine
, vol.361
, pp. 1045-1057
-
-
Wallentin, L.1
-
17
-
-
70149101223
-
Ticagrelor Versus Clopidogrel in Patients With Acute Coronary Syndromes
-
Supplementary appendix available at
-
Wallentin, L. 2009b. Ticagrelor Versus Clopidogrel in Patients With Acute Coronary Syndromes. New England Journal of Medicine, 361: 1045 - 1057. Supplementary appendix available at http://www.nejm.org/doi/suppl/10.1056/NEJMoa0904327/suppl_file/nejm_wallentin_1045sa1.pdf
-
(2009)
New England Journal of Medicine
, vol.361
, pp. 1045-1057
-
-
Wallentin, L.1
-
18
-
-
80052611377
-
Anti-Platelet Therapy: Cyclo-oxygenase Inhibition and the Use of Aspirin With Particular Regard to Dual Anti-platelet Therapy
-
Warner, T. D., Nylander, S. and Whatling, C. 2011. Anti-Platelet Therapy: Cyclo-oxygenase Inhibition and the Use of Aspirin With Particular Regard to Dual Anti-platelet Therapy. British Journal of Clinical Pharmacology, 72: 619 - 633.
-
(2011)
British Journal of Clinical Pharmacology
, vol.72
, pp. 619-633
-
-
Warner, T.D.1
Nylander, S.2
Whatling, C.3
|