Journal Publications

User Rating: 5 / 5

Star ActiveStar ActiveStar ActiveStar ActiveStar Active
 

 

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

 

 

Image   Image   Image   Image  

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Site Last Modified

  • Last Modified: Tuesday 19 March 2024, 14:51:34.
© Copyright 2023 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Search

Main Menu English