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Title: Toxic Signal Detection in Pharmacogigilance of Anticancer Drugs in Cancer Treatment
Researcher: Singhal Sharvankumar
Guide(s): Bhasawat Chakraborty
cancer treatment
Toxic Signal
University: Nirma University
Completed Date: 17/03/2016
Abstract: newline newlinePharmacovigilance (PV) is a continuous and ongoing process which allows assessing the safety newlineof medicinal product through its life cycle. Pharmacovigilance collects, records, codes Adverse newlineDrug Events (ADEs) / Adverse drug reactions (ADRs) analyses and assesses the reports, newlinepromotes the safe use of drugs, creates appropriate structures, and means of communication newlineneeded to perform its tasks. Spontaneous individual case safety reports gatherings are the main newlineasset for early discovery of unknown ADR to drugs once they are introduced to the general newlinepublic. The objective of the study was to identify possible significant signal associated with newlinepaclitaxel, docetaxel, cisplatin, carboplatin, cyclophoshphamide and vincristine by searching newlinedatabase of Canada Adverse Drug Reaction Monitoring Program (CADRMP) newlinePatient and Methods newlineA total of 10429 reports of patients between January 1970 to March 2010 were downloaded newlinefrom Canada Adverse reaction Monitoring Program website. These reports contained newlineinformation of adverse events associated with all other drugs inclusive of paclitaxel, docetaxel, newlinecisplatin, carboplatin, cyclophoshphamide and vincristine. Adverse drug reaction (ADR) signal newlinedetection were determined by proportional reporting ratio (PRR), reporting odds ratio (ROR), newlinePRR calculated by chi-square statistics, 95% confidence interval of PRR, observed to expected newline(O/E) ratio and De Mouchel method calculated PRR. Information component (IC) was given newlineby Bayesian confidence propagation neural network. (As per regulatory criteria, PRR and#8805; 2, ROR newlineand#8805; 1, Chi-square statistics calculated PRR and#8805; 4 and lower bound limit of 95% CI of PRR and#8805; 1 to newlineconsider particular adverse drug reaction as a signal. Further by BCPNN method, if IC and#8722; 2SD newlineand#8804; 0 then that drug-ADR pair considered as no signal; if 0 lt IC and#8722; 2SD and#8804;1.5, then that drug-ADR newlinepair considered as weak signal; if 1.5 lt ICand#8722;2SD and#8804; 3.0, then that drug-ADR pair considered as newlinemiddle signal; if IC and#8722; 2SD gt 3.0, then that drug-ADR pair considered as strong signal).
Appears in Departments:Institute of Pharmacy

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01 title page.pdfAttached File47.25 kBAdobe PDFView/Open
02 certificate scan.pdf344.37 kBAdobe PDFView/Open
03 abstract.pdf278.14 kBAdobe PDFView/Open
04 declration scan.pdf347.11 kBAdobe PDFView/Open
05 acknoledgement.pdf22.43 kBAdobe PDFView/Open
06 contents.pdf13.03 kBAdobe PDFView/Open
07 list of tables.pdf25.79 kBAdobe PDFView/Open
08 list of figures.pdf15.11 kBAdobe PDFView/Open
09 abbreviations.pdf18.68 kBAdobe PDFView/Open
10 chapter 1.pdf864.4 kBAdobe PDFView/Open
11 chapter 2.pdf556.75 kBAdobe PDFView/Open
12 chapter 3.pdf42.01 kBAdobe PDFView/Open
13 chapter 4.pdf314.76 kBAdobe PDFView/Open
14 chapter 5.pdf600.12 kBAdobe PDFView/Open
15 chapter 6.pdf136.13 kBAdobe PDFView/Open
16 conclusion & summary.pdf20.32 kBAdobe PDFView/Open
17 publications.pdf5.16 MBAdobe PDFView/Open
18 bibliography.pdf130.52 kBAdobe PDFView/Open
19 appendices.pdf2.28 MBAdobe PDFView/Open

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