Risk Management Strategy

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#	Title	Journal	Year	Citations
1	Gold Standards in Pharmacovigilance	Drug Safety	2007	77
2	Safety Related Drug-Labelling Changes	Drug Safety	2004	52
3	An Experimental Investigation of Masking in the US FDA Adverse Event Reporting System Database	Drug Safety	2010	50
4	Data Mining in Pharmacovigilance	Drug Safety	2005	47
5	Drug-induced pancreatitis: lessons in data mining	British Journal of Clinical Pharmacology	2004	45
6	Early Postmarketing Drug Safety Surveillance: Data Mining Points to Consider	Annals of Pharmacotherapy	2004	37
7	Potential Use of Data-Mining Algorithms for the Detection of ???Surprise??? Adverse Drug Reactions	Drug Safety	2007	34
8	Communication of findings in pharmacovigilance: use of the term “signal” and the need for precision in its use	European Journal of Clinical Pharmacology	2005	31
9	Illusions of objectivity and a recommendation for reporting data mining results	European Journal of Clinical Pharmacology	2007	25
10	Association between gastric acid suppressants and Clostridium difficile colitis and community-acquired pneumonia: analysis using pharmacovigilance tools	International Journal of Infectious Diseases	2007	22
11	What Counts in Data Mining?	Drug Safety	2006	19
12	Data mining in pharmacovigilance: lessons from phantom ships	European Journal of Clinical Pharmacology	2006	19
13	Reports of hyperkalemia after publication of RALES—a pharmacovigilance study	Pharmacoepidemiology and Drug Safety	2006	16
14	Response to letter by Levine et al.	British Journal of Clinical Pharmacology	2006	16
15	Detection of Spironolactone-Associated Hyperkalaemia Following the Randomized Aldactone Evaluation Study (RALES)	Drug Safety	2007	15
16	Endotoxin-Like Reactions With Intravenous Gentamicin Results From Pharmacovigilance Tools Under Investigation	Infection Control and Hospital Epidemiology	2005	11
17	Signal Detection in the Pharmaceutical Industry	Drug Safety	2007	11
18	Antidepressants that inhibit neuronal norepinephrine reuptake are not associated with increased spontaneous reporting of cardiomyopathy	Journal of Psychopharmacology	2010	11
19	Paradoxical Reactions: Under-Recognized Adverse Effects of Drugs?	Drug Safety	2006	8
20	The Importance of Reporting Negative Findings in Data Mining	Pharmaceutical Medicine	2008	8
21	Data mining, drug safety, and molecular pharmacology: potential for collaboration	Annals of Pharmacotherapy	2004	6
22	A case report of rhabdomyolysis with pentamidine that prompted a retrospective evaluation of a pharmacovigilance tool under investigation	British Journal of Clinical Pharmacology	2004	6
23	Rosiglitazone-induced immune thrombocytopenia	Platelets	2006	6
24	Postmarketing hepatic adverse event experience with PEGylated/non-PEGylated drugs: a disproportionality analysis	European Journal of Gastroenterology and Hepatology	2007	5
25	Data Mining in Pharmacovigilance	Pharmaceutical Medicine	2007	5
26	Reports of Acute Angle Closure Glaucoma-Related Adverse Events with SSRIs: Results of a Disproportionality Analysis	CNS Drugs	2006	4
27	Extension of Points on Clarifying Terminology in Drug Safety	Drug Safety	2006	4
28	Number Needed to Detect	Pharmaceutical Medicine	2008	1

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