Validation of a genetic test for detection of HLAB*1502 / Azraan Zakariah

Validation of a genetic test for detection of HLAB*1502 / Azraan Zakariah

The person-to-person variability of drug responses a major problem in clinical practice and drug development which may leads to adverse drug reactions (ADRs). HLA-B gene associated with ADRs include hypersensitivity to carbamazepine and phenytoin, the most common causes of antiepileptic drugs induc...

Full description

Saved in:
Bibliographic Details
Main Author: Zakariah, Azraan
Format: Thesis
Language:English
Published: 2011
Subjects:
Drugs and their actions
Genetic aspects
Online Access:https://ir.uitm.edu.my/id/eprint/66676/1/66676.pdf
Tags: Add Tag
No Tags, Be the first to tag this record!
id my-uitm-ir.66676
record_format uketd_dc
spelling my-uitm-ir.666762022-09-14T03:50:22Z Validation of a genetic test for detection of HLAB*1502 / Azraan Zakariah 2011 Zakariah, Azraan Drugs and their actions Genetic aspects The person-to-person variability of drug responses a major problem in clinical practice and drug development which may leads to adverse drug reactions (ADRs). HLA-B gene associated with ADRs include hypersensitivity to carbamazepine and phenytoin, the most common causes of antiepileptic drugs induced cutaneous adverse reactions, Stevens-Johnson syndrome. Therefore, Food and Drug Administration (FDA) had recommended genetic screening of HLAB* 1502 in patients prior to initiation of carbamazepine or phenytoin therapy. PCR genotyping kit has been developed by a team of researchers in Pharmacogenomics Centre (PROMISE) to detect the presence of HLA-B*1502 allele. The genotyping kit for detection of HLAB*1502 needs to be validated because it has become an important part for acceptance of a new diagnostic method as required by the OECD and ICH. The genotyping kit needed to prove its reliability and relevance for its ability to detect HLAB*1502. Therefore, in this study, a validation strategy has been planned and tested based on several international guidelines. 2011 Thesis https://ir.uitm.edu.my/id/eprint/66676/ https://ir.uitm.edu.my/id/eprint/66676/1/66676.pdf text en public degree Universiti Teknologi MARA (UiTM) Faculty of Pharmacy Teh, Lay Kek
institution Universiti Teknologi MARA
collection UiTM Institutional Repository
language English
advisor Teh, Lay Kek
topic Drugs and their actions
Genetic aspects
spellingShingle Drugs and their actions
Genetic aspects
Zakariah, Azraan
Validation of a genetic test for detection of HLAB*1502 / Azraan Zakariah
description The person-to-person variability of drug responses a major problem in clinical practice and drug development which may leads to adverse drug reactions (ADRs). HLA-B gene associated with ADRs include hypersensitivity to carbamazepine and phenytoin, the most common causes of antiepileptic drugs induced cutaneous adverse reactions, Stevens-Johnson syndrome. Therefore, Food and Drug Administration (FDA) had recommended genetic screening of HLAB* 1502 in patients prior to initiation of carbamazepine or phenytoin therapy. PCR genotyping kit has been developed by a team of researchers in Pharmacogenomics Centre (PROMISE) to detect the presence of HLA-B*1502 allele. The genotyping kit for detection of HLAB*1502 needs to be validated because it has become an important part for acceptance of a new diagnostic method as required by the OECD and ICH. The genotyping kit needed to prove its reliability and relevance for its ability to detect HLAB*1502. Therefore, in this study, a validation strategy has been planned and tested based on several international guidelines.
format Thesis
qualification_level Bachelor degree
author Zakariah, Azraan
author_facet Zakariah, Azraan
author_sort Zakariah, Azraan
title Validation of a genetic test for detection of HLAB*1502 / Azraan Zakariah
title_short Validation of a genetic test for detection of HLAB*1502 / Azraan Zakariah
title_full Validation of a genetic test for detection of HLAB*1502 / Azraan Zakariah
title_fullStr Validation of a genetic test for detection of HLAB*1502 / Azraan Zakariah
title_full_unstemmed Validation of a genetic test for detection of HLAB*1502 / Azraan Zakariah
title_sort validation of a genetic test for detection of hlab*1502 / azraan zakariah
granting_institution Universiti Teknologi MARA (UiTM)
granting_department Faculty of Pharmacy
publishDate 2011
url https://ir.uitm.edu.my/id/eprint/66676/1/66676.pdf
_version_ 1783735630014971904

Similar Items