Journal Publications

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2024

Use of biosimilars: A systematic review of published position statements and recommendations from health organisations and societies.

BioDrugs 2024

Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST.

JMIR Med Inform 2024;12:e49643

 

2023

Determination of ethanol, isopropyl alcohol and methanol in alcohol-based hand sanitiser to ensure product quality, safety and efficacy.

Scientific Report 2023; 13, Article Number: 9478

Carbamazepine‐induced Severe Cutaneous Adverse Drug Reactions: A 21‐year comparison between children and adults in Malaysia

Clinical Pharmacology 2023; 63(10): 1126-1132 

Hearing loss and tinnitus associated with COVID-19 vaccines: An analysis from the national pharmacovigilance database in Malaysia.

Asian Pacific Journal of Tropical Medicine 2023; 16(7): 289-295

Thrombocytopenia and venous thromboembolic events after BNT162b2, CoronaVac, ChAdOx1 vaccines and SARS-CoV-2 infection: a self-controlled case series study

Scientific Reports 2023; 13, Article Number: 20471 

Regulatory Oversight of Cell and Gene Therapy Products in Malaysia.

In: Galli, M.C. (eds) Regulatory Aspects of Gene Therapy and Cell Therapy Products. Advances in Experimental Medicine and Biology, vol 1430. Springer, Cham.

National Regulatory Conference 2023 poster abstracts.

Pharmacy Research Reports Volume 6 Supplement Issue November 2023

 

2022

Pharmacokinetic–Pharmacometabolomic Approach in Early-Phase Clinical Trials: A Way Forward for Targeted Therapy in Type 2 Diabetes. 

Pharmaceutics 2022; 14: 1268.

Pharmacokinetics and Metabolomic Profiling of Metformin and Andrographis paniculata: A Protocol for a Crossover Randomised Controlled Trial. 

J. Clin. Med. 2022; 11: 3931.

Incidence of Antiseizure Medication–Induced Severe Cutaneous Adverse Reactions in Malaysia. 

The Journal of Clinical Pharmacology 2022, 62(8): 983-991

Incidence of allopurinol-induced severe cutaneous adverse drug reaction in Malaysia.

British Journal of Clinical Pharmacology 2022, 88(8): 3782-3788

Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia:

A self-controlled case series study.

Vaccine 2022; 40 (32): 4394-4402

 

 

2021

Cell and gene therapy products in Malaysia: a snapshot of the industry's current regulation preparedness Cytotherapy 2021 Dec;23(12):1108-1113

Allopurinol-Induced Severe Cutaneous Adverse Drug Reactions: An Analysis of Spontaneous Reports in Malaysia (2000-2018)

Ther Innov Regul Sci.; 55(3):514-522.

 

 

2020

Allopurinol-induced severe cutaneous adverse drug reactions: Risk minimisation measures in Malaysia.

Pharmacoepidemiol Drug Saf.; 29(10): 1254– 1262. 

An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology. 

Therapeutic Innovation & Regulatory Science; 54: 1215–1224

 

 

2019

Unique product quality consideration in vaccine development, registration and new program implementation in Malaysia,

Human Vaccines & Immunotherapeutics; 16(3): 530-538

Enhancing Post-market Surveillance Through Laboratory Testing on Blue-green Algae Products in Malaysia. 

International Journal Of Biomedical And Clinical Sciences; 4(3): 82-90.

 

 

2017

Phosphodiesterase-5 inhibitors and their analogues as adulterants of herbal and food products: analysis of the Malaysian market, 2014–16,

Food Additives & Contaminants: Part A; 34(7): 1101-1109

An Update on the Registration of Biosimilars in Malaysia.

Therapeutic Innovation & Regulatory Science; 51(1): 55-59. 

A qualitative study among potential manufacturers on the development of ‘Made in Malaysia’ biological products: Challenges and proposed solutions. 

Journal of Commercial Biotechnology; 23(4): 44-61. 

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

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