NPRA

Journal Publications

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2026

Access to new antibacterials in 10 Asian countries: An Asian network for surveillance of resistant pathogens study

Int J Antimicrob Agents 2026; 67(6):107769

2025

Efficacy of Fetal Wharton’s Jelly Mesenchymal Stem Cells-Derived Small Extracellular Vesicles in Metabolic Syndrome

Biomolecules 2025; 15(1):44

Quality Control of Fetal Wharton's Jelly Mesenchymal Stem Cells-Derived Small Extracellular Vesicles

Int J Nanomedicine 2025;20:1807-1820

Precision Medicine in Oncology: Imatinib Dosing in the Obese Cancer Population Using Virtual Clinical Trials

CPT Pharmacometrics Syst Pharmacol 2025; 14(6):1050-1064

Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach

Ther Innov Regul Sci (2025)

GC–MS method for routine analysis of camphor, menthol, methyl salicylate, and thymol in traditional topical products: Addressing compliance and adulteration from Malaysia's National Pharmaceutical Regulatory Agency

Results in Chemistry 2025; 18: 102721

Safety Evaluation and Biodistribution of Fetal Umbilical Cord Mesenchymal Stem Cells-Derived Small Extracellular Vesicles in Sprague Dawley Rats

Int J Mol Sci 2025;26(14):6806

Clinical pharmacokinetics and pharmacometabolomics of Andrographis paniculata capsules: Bridging drug disposition and metabolic response to precision medicine

Naunyn Schmiedebergs Arch Pharmacol 2025

Evaluation of the antiproliferative effect of Zingiber zerumbet essential oil against oral squamous cell carcinoma

S Afr J Bot 2025; 187: 337-350

A Feasibility Study for Quality Control Testing on Raw Materials Used in Natural Products in Malaysia

Pharmacy Research Reports 2025; 8 (2)

Mortality Outcomes associated with Meropenem Front-Loading Dose in Critically Ill Septic Patients with Acute Kidney Injury

Sarawak Journal of Pharmacy 2025;11(1):1-9

2024

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

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

LL37 Microspheres Loaded on Activated Carbon-chitosan Hydrogel: Anti-bacterial and Anti-toxin Wound Dressing for Chronic Wound Infections

AAPS PharmSciTech 2024;25, Article number:110

Repurposing cardiac glycosides for anticancer treatment: a review of clinical studies.

Drug Discov Today 2024:104129

Strategies to enhance risk communication about medicines in Malaysia: a Delphi study among multinational experts

BMC Health Services Research 2024;24, Article number:1019

12th National Pharmacy R&D Conference 2024 abstracts

Pharmacy Research Reports Volume 7 Supplement Issue August 2024

Unlocking Natural Potential: Antibody-Drug Conjugates With Naturally Derived Payloads for Cancer Therapy

Phytotherapy Research 2024

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.