Introduction to risk management plans in the Singapore context

Autor: Liesbet L. Tan, Christine Su-Ching Ho, Cheng Leng Chan

Publikováno v: Singapore Med J

A risk management plan (RMP) contains an overview of important safety concerns associated with the use of a therapeutic product (TP) and proposed pharmacovigilance activities to monitor and manage these safety concerns in the post-approval stage. The

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ba8bd36d484477c02cd69f0b15e65936
https://doi.org/10.11622/smedj.2019111

Tailoring of recommendations to reduce serious cutaneous adverse drug reactions: a pharmacogenomics approach

Autor: Archana Vasudevan, Cynthia Sung, Dorothy Toh, Nai Lee Lui, Aisha Lateef, Liesbet L. Tan, Shan Xian Lee, Wei Chuen Tan-Koi, Cheng Leng Chan, Evelyn Sc Koay, Ee Chee Ren, Yen Loo Lim, Celine Loke, Yong Kwang Tay, Yong Yeow Chong, Michael Limenta, Derrick Aw, Shiu Ming Pang, Edmund Jd Lee, Di Dong, Haur Yueh Lee

Publikováno v: Pharmacogenomics. 18:881-890

The Health Sciences Authority launched a pharmacogenetics initiative in 2008 to facilitate evaluation of pharmacogenetics associations pertinent for Chinese, Malays and Indians in Singapore. The aim was to reduce the incidence and unpredictability of

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::018befacaec0b141cc0d1cadbf8eb6f0
https://doi.org/10.2217/pgs-2017-0016

Building pharmacogenetics into a pharmacovigilance program in Singapore: using serious skin rash as a pilot study

Autor: S K Tan, Y Y Chong, D C W Aw, E S C Koay, Liesbet L. Tan, Celine Loke, Y C Chan, Haur Yueh Lee, Y K Tay, Ee Chee Ren, Cheng Leng Chan, A Lateef, A Vasudevan, Shih-Hui Lim, Edmund Jd Lee, T. Thirumoorthy, S M Pang, Cynthia Sung, Dorothy Toh

Publikováno v: The pharmacogenomics journal. 14(4)

To study the possible genetic associations with adverse drug reactions (ADR), the Singapore Health Sciences Authority (HSA) has piloted a program to collect DNA and phenotype data of ADR cases as part of its pharmacovigilance program. Between 2009 an

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7203c879908c1e692f68eb351f617c70
https://pubmed.ncbi.nlm.nih.gov/24394201

Pharmacogenetic risk for adverse reactions to irinotecan in the major ethnic populations of Singapore: regulatory evaluation by the health sciences authority

Autor: Cynthia Sung, Liesbet L. Tan, Dorothy Toh, Pui Ling Lee

Publikováno v: Drug safety. 34(12)

For genetic polymorphisms known to alter drug effect or safety, regulatory authorities can tap into population genomic databases and other sources of allele and genotype distribution data to make a more informed decision about the anticipated impact

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::56d3509c3ae3b7cb0de6c3b4de12a66a
https://pubmed.ncbi.nlm.nih.gov/22077505

Usage Pattern of Carbamazepine and Associated Severe Cutaneous Adverse Reactions in Singapore Following Implementation of HLA-B*15:02 Genotyping as Standard-of-Care.

Autor: Sung C; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore, Singapore.; Health Services & Systems Research Programme, Duke-NUS Medical School, Singapore, Singapore., Tan L; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore, Singapore., Limenta M; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore, Singapore., Ganesan G; Policy Research and Evaluation Division, Ministry of Health, Singapore, Singapore., Toh D; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore, Singapore., Chan CL; Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore, Singapore.

Publikováno v: Frontiers in pharmacology [Front Pharmacol] 2020 May 07; Vol. 11, pp. 527. Date of Electronic Publication: 2020 May 07 (Print Publication: 2020).