Validation of a genetic test for detection of HLAB*1502. Degree thesis, Universiti Teknologi MARA, Shah Alam. (2011)
Abstract
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.
| Item Type: | Thesis (Degree) |
|---|---|
| Keywords: | HLA-B, Drug reaction, Genetic testing, Polymerase Chain Reaction (PCR), Genotyping kit |
| Taxonomy: | By Niche > Genome > Genomes By Niche > Genome > Human Genome Research |
| Local Content Hub: | Niche > Genome |
| Depositing User: | Hazrul Amir Tomyang (Puncak Alam) |
| Date Deposited: | 31 May 2023 09:10 |
| Last Modified: | 31 May 2023 09:10 |
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