-
4
-
-
84890220859
-
Preparing for safety issues following drug approval: preapproval risk management considerations. Submitted to
-
Dieck G. Sharrar R. (2013) Preparing for safety issues following drug approval: preapproval risk management considerations. Submitted to Therapeutic Advances in Drug Safety.
-
(2013)
Therapeutic Advances in Drug Safety
-
-
Dieck, G.1
Sharrar, R.2
-
5
-
-
0038931405
-
Bayesian data mining in large frequency tables, with an application to the FDA reporting system
-
DuMouchel W. (1999) Bayesian data mining in large frequency tables, with an application to the FDA reporting system. Am Stat 53: 177–202.
-
(1999)
Am Stat
, vol.53
, pp. 177-202
-
-
DuMouchel, W.1
-
7
-
-
84878911320
-
Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use
-
European Parliament and Council of the European Union, Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use, Off J Eur Union, (2010), L348, 74-99
-
(2010)
Off J Eur Union
, vol.L348
, pp. 74-99
-
-
-
8
-
-
84926485912
-
Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products
-
European Parliament and Council of the European Union, Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products, Off J Eur Union, (2010), 3L98, 1-16
-
(2010)
Off J Eur Union
, vol.3L98
, pp. 1-16
-
-
-
9
-
-
0035700740
-
Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
-
Evans S. Waller P. Davis S. (2001) Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 10: 483–486.
-
(2001)
Pharmacoepidemiol Drug Saf
, vol.10
, pp. 483-486
-
-
Evans, S.1
Waller, P.2
Davis, S.3
-
10
-
-
84873876862
-
Adverse reaction signaling and disproportionality analysis: an update
-
Faich G. Morris J. (2012) Adverse reaction signaling and disproportionality analysis: an update. Drug Inf J 46: 708–714.
-
(2012)
Drug Inf J
, vol.46
, pp. 708-714
-
-
Faich, G.1
Morris, J.2
-
11
-
-
84993731915
-
-
Washington DC: FDA,. Available at:, [accessed 21 March 2012]
-
Food and Drug Administration (FDA) (2011a) Adverse Event Reporting System (AERS) statistics (31 December 2011). Washington DC: FDA. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm [ accessed 21 March 2012].
-
(2011)
Adverse Event Reporting System (AERS) statistics (31 December 2011)
-
-
-
14
-
-
84886952789
-
-
Step 2 version dated 1 February 2012., Washington DC: FDA.
-
Food and Drug Administration (FDA) (2012) Periodic benefit–risk evaluation report (PBRER) E2C (R2). Step 2 version dated 1 February 2012. Washington DC: FDA.
-
(2012)
Periodic benefit–risk evaluation report (PBRER) E2C (R2)
-
-
-
20
-
-
84886952789
-
-
Current Step 4 version, dated, 17, December, 2012,. Available at:, accessed 15 May 2013
-
International Conference on Harmonisation. (2012) (ICH) E2C (R2) Periodic Benefit-Risk Evaluation Report. Current Step 4 version, dated 17 December 2012. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2C/E2C_R2_Step4.pdf (accessed 15 May 2013).
-
(2012)
(ICH) E2C (R2) Periodic Benefit-Risk Evaluation Report
-
-
-
21
-
-
84890171416
-
-
Bethesda, MD: Foundation of the National Institutes of Health,. Available at, accessed 20 June 2012
-
Observational Medical Outcomes Partnership (OMOP) (2009) Observational Medical Outcomes Partnership [online]. Bethesda, MD: Foundation of the National Institutes of Health. Available at http://omop.fnih.org/node/22 (accessed 20 June 2012).
-
(2009)
Observational Medical Outcomes Partnership [online]
-
-
-
22
-
-
84890202144
-
-
Bethesda, MD: Foundation of the National Institutes of Health,. Available at, accessed 17 March 2013
-
Observational Medical Outcomes Partnership (OMOP) (2012) OMOP 2012 research [online]. Bethesda, MD: Foundation of the National Institutes of Health. Available at http://omop.fnih.org/Research (accessed 17 March 2013).
-
(2012)
OMOP 2012 research [online]
-
-
-
23
-
-
84862932391
-
Supplement: The U.S. Food and Drug Administration–s Mini-Sentinel Program
-
(eds), (Suppl. S1)
-
Platt R. Carnahan R. (eds) (2012) Supplement: The U.S. Food and Drug Administration–s Mini-Sentinel Program. Pharmacoepidemiol Drug Saf 21(Suppl. S1): 1–303.
-
(2012)
Pharmacoepidemiol Drug Saf
, vol.21
, pp. 1-303
-
-
Platt, R.1
Carnahan, R.2
-
25
-
-
78751688048
-
Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership
-
Stang P. Ryan P. Racoosin J. Overhage J. Hartzema A. Reich C. (2010) Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership. Ann Intern Med 153: 600–606.
-
(2010)
Ann Intern Med
, vol.153
, pp. 600-606
-
-
Stang, P.1
Ryan, P.2
Racoosin, J.3
Overhage, J.4
Hartzema, A.5
Reich, C.6
-
26
-
-
84890153035
-
-
Rockville, MD: VAERS,. Available at, [accessed 18 March 2013]
-
Vaccine Adverse Event Reporting System (VAERS) (2013) VAERS data 13 Feb 2013 [online]. Rockville, MD: VAERS. Available at http://vaers.hhs.gov/data/data [ accessed 18 March 2013].
-
(2013)
VAERS data 13 Feb 2013 [online]
-
-
-
27
-
-
84993780707
-
-
Uppsala, Sweden: Uppsala Monitoring Centre,. Available at:, accessed on 18 March 2013
-
WHO Uppsala Monitoring Centre (2012) Reporting trends [online]. Uppsala, Sweden: Uppsala Monitoring Centre. Available at: http://www.who-umc.org/DynPage.aspx?id=108476&mn1=7347&mn2=7252&mn3=7322&mn4=7558 (accessed on 18 March 2013).
-
(2012)
Reporting trends [online]
-
-
|