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Data Mining & Signal Detection In Pv

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Saúde e medicinaTecnologiaNegócios
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Dr. Bhaswat S. Chakraborty Senior VP, R&D, Cadila Pharmaceuticals January 22, 2009 Presented at Pharmacovigilance 2010, January 21-22, 2010
Risk Management and Pharmacovigilance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
And Yet… ,[object Object],[object Object],[object Object],[object Object]
Two categories of approved drug ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Premature Approval? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Market Uptake and Sales Volume ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
 
J. Herson. In Data and Safety Monitoring Committees in Clinical Trials
Having an Adverse Events Database ,[object Object],[object Object],[object Object],[object Object],[object Object]
Desirable Attributes of AE Database Software ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Gavali, Kulkarni, Kumar and Chakraborty (2009), Ind J Pharmacol , 41, 162-166 or any comprehensive database Collection of ICSRs from CADRMP Conversion of free text to structured information Data cleaning and duplicate detection Applying quantitative or statistical methods Computing an accurate measure for SD
Targeted Event Y All other events Total Targeted Drug X A B A+B All other drugs C D C+D Total A+C B+D A+B+C+D
Criteria for a Toxic Disproportional ADR ,[object Object],[object Object],Significant disproportional Signal is detected when  2 is ≥ 4.0 and the rest ≥ 2.0
Casestudy Example: Propranolol-Bradycardia ,[object Object],[object Object],[object Object],[object Object],Gavali, Kulkarni, Kumar and Chakraborty (2009), Ind J Pharmacol , 41, 162-166 Bradycardia Not Bradycardia Propranolol HCL 4 82 Not Propranolol HCL 52 2749
Casestudy Examples – Significant Signals ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Source: LAREB
Thank You Very Much Acknowledgment: Sharwan Singhal

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Data Mining & Signal Detection In Pv

  • 1. Dr. Bhaswat S. Chakraborty Senior VP, R&D, Cadila Pharmaceuticals January 22, 2009 Presented at Pharmacovigilance 2010, January 21-22, 2010
  • 2.
  • 3.
  • 4.
  • 5.
  • 6.
  • 7.  
  • 8.  
  • 9. J. Herson. In Data and Safety Monitoring Committees in Clinical Trials
  • 10.
  • 11.
  • 12. Gavali, Kulkarni, Kumar and Chakraborty (2009), Ind J Pharmacol , 41, 162-166 or any comprehensive database Collection of ICSRs from CADRMP Conversion of free text to structured information Data cleaning and duplicate detection Applying quantitative or statistical methods Computing an accurate measure for SD
  • 13. Targeted Event Y All other events Total Targeted Drug X A B A+B All other drugs C D C+D Total A+C B+D A+B+C+D
  • 14.
  • 15.
  • 16.
  • 17. Thank You Very Much Acknowledgment: Sharwan Singhal

Notas do Editor

  1. Alosetron is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS). Grepafloxacin hydrochloride (trade name Raxar, Glaxo Wellcome) is an oral broad-spectrum quinoline antibiotic agent used to treat bacterial infection. Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAId) that has now been withdrawn over safety concerns.
  2. Alosetron is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS). Grepafloxacin hydrochloride (trade name Raxar, Glaxo Wellcome) is an oral broad-spectrum quinoline antibiotic agent used to treat bacterial infection. Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAId) that has now been withdrawn over safety concerns.
  3. In the USA, a black box warning (also sometimes called a black label warning or boxed warning ) is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning.
  4. Proportional Reporting Ratio (PRR); Reporting Odds Ratio (ROR);