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Title: Bioequivalence Studies to Evaluate Efficacy and Safety of Antiretroviral and Antituberculosis Drug
Researcher: Halde, Supriya
Guide(s): Chintamaneni, Meena
Keywords: Antiretroviral Drug
Antituberculosis Drug
Issue Date: 22-May-2013
University: Narsee Monjee Institute of Management Studies
Award Date: 27/02/2013
Abstract: HIV and tuberculosis are two leading causes of death all over the world. Bioequivalence is the newlinemandatory requirement for generic medicines to launch the product in market. Generic medicines are equivalent to branded medicines in terms of safety, dosage, strength, quality and performance but differ largely in cost hence they are preferred for the treatment. Generic medicines play important role in pharmaco-economics in country like India. Nevirapine, Efavirenz, Emtricitabine from antiretroviral category and Terizidone from antituberculoisis category were selected for the research work. Method Development was performed to develop fast but accurate and precise methods for the estimation of these drug molecules. All the developed methods were validated as per the international guidelines of method validation. The application of these validated methods was evaluated on samples of bioequivalence studies. All these developed methods can be routinely used for the analysis of these drug molecules from human plasma. Alternative methods like urine analysis and dried matrix spot analysis were also developed for emtricitabine and efavirenz respectively. These methods were validated and their performance was evaluated on bioequivalence study samples. Urine newlineanalysis and dried matrix spot analysis serve as an economical alternative to traditional methods and can be used in pilot study analysis.
Pagination: 358p.
Appears in Departments:Department of Pharmacy

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01_title page.pdfAttached File16.17 kBAdobe PDFView/Open
02_aknowledgement.pdf7.83 kBAdobe PDFView/Open
03_statement by candidate and certificate.pdf9.02 kBAdobe PDFView/Open
04_approval sheet and abstract.pdf9.44 kBAdobe PDFView/Open
05_content.pdf11.26 kBAdobe PDFView/Open
06_list of tables.pdf22.1 kBAdobe PDFView/Open
07_list of figures.pdf12.69 kBAdobe PDFView/Open
08_chapter titles.pdf14.92 kBAdobe PDFView/Open
09_chapter 1.pdf191.42 kBAdobe PDFView/Open
10_chapter 2.pdf14.02 kBAdobe PDFView/Open
11_chapter 3.pdf59.8 kBAdobe PDFView/Open
12_chapter 4.1.pdf249.79 kBAdobe PDFView/Open
13_chapter 4.2.pdf785.96 kBAdobe PDFView/Open
14_chapter 4.3.pdf622.03 kBAdobe PDFView/Open
15_chapter 4.4.pdf410.18 kBAdobe PDFView/Open
16_chapter 5.pdf84.79 kBAdobe PDFView/Open
17_chapter 6.pdf2.8 MBAdobe PDFView/Open
18_references.pdf36.58 kBAdobe PDFView/Open
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