https://he01.tci-thaijo.org/index.php/fdajournal <p><strong>The Thai Food and Drug Journal (TFDJ)</strong> is a science and technology journal copyrighted by the Food and Drug Administration of Thailand. It accepts two types of articles: academic articles and research articles about health products and consumer protection of health products, including food, medicine, cosmetics, medical devices, hazardous substances as used in the home, and drugs used medically.</p> <p><strong> </strong></p> <p>TFDJ has approximately 6–10 articles per issue and publishes three issues every four months per year.</p> <p> Issue 1: January – April</p> <p> Issue 2: May – August</p> <p> Issue 3: September – December</p> <p><strong> </strong></p> <p>Published articles were considered by the editorial team and through a double-blinded review process by experts (peer review) who were selected by the editorial team of at least two people, and if necessary, a third expert will be selected to be an additional reviewer with information concealed. This is a way to prevent bias or prejudice or to receive any benefits.</p> <p><strong> </strong></p> <p>Free of charge for authors and readers.</p> <p><strong> </strong></p> Food and drug administration en-US Thai Food and Drug Journal 2730-3179 https://he01.tci-thaijo.org/index.php/fdajournal/article/view/277535 <p><strong>Background:</strong> Bacterial endotoxins, the pyrogens derived from gram-negative bacteria, are heat-stable and can contaminate vaccine, injectable drug, and medical device products for human and veterinary use during manufacturing. The Limulus Amebocyte Lysate (LAL) method for analyzing the endotoxin determination uses a lysate of horseshoe crab blood, which has a high post-bleeding mortality rate. In accordance with the 3Rs principle of animal welfare, there has been a global effort to find a replacement for the use of animals. A recombinant factor C (rFC) assay has been developed as a replacement for the horseshoe crab lysate assay. Currently, the European and United State Pharmacopoeias have recognized it as a standard method.</p> <p><strong>Objectives: </strong>To study the validation of the recombinant factor C method for analyzing the endotoxin determination for use as a standard method in quality control of biological products to cover all analytical methods in European and United Stated pharmacopoeias.</p> <p><strong>Methods: </strong>This experimental research was conducted from October 2022 to December 2023 for validation of the endotoxin determination using recombinant factor C method in the parameters such as linearity, accuracy and precision (repeatability and reproducibility by different days and analyst).</p> <p><strong>Results:</strong> The study found that the method demonstrated a linear relationship between the measured values and the concentration of the standard with a correlation coefficient of &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;≥ 0.980. The accuracy was assessed by spiking known concentrations of endotoxin into samples, the % recovery was within the acceptance criteria of 50-200%. The precision was evaluated by repeatability and intermediate precision studies. The coefficient of variation (CV) of % recovery was less than 25%. It could be used as a standard method for conducting the endotoxin determination in human vaccine and monoclonal antibody products. However, plasma-derived or blood products could not be analyzed due to interference from the samples.</p> <p><strong>Conclusions:</strong> The recombinant factor C method, which has been studied for its accuracy, is suitable and reliable. It can be used as a standard method for analyzing the quality of vaccines and monoclonal antibodies sold in Thailand.</p> Kanitta Phuwanartnaranubarn Assajun Amen Ekalak Songtan Copyright (c) 2025 Thai Food and Drug Journal https://creativecommons.org/licenses/by/4.0/ 2025-02-27 2025-02-27 32 1 18 32 https://he01.tci-thaijo.org/index.php/fdajournal/article/view/277538 <p><strong>Background:</strong> Salmonellosis is a significant public health concern caused by <em>Salmonella </em>spp., commonly found in the environment, water, and food ingredients.</p> <p><strong>Objectives:</strong> To analyze the contamination of <em>Salmonella </em>spp. and <em>Salmonella</em> Enteritidis in meat samples obtained from supermarkets in Mueang Loei District, Loei Province, between April and August 2023.</p> <p><strong>Methods: </strong>A random sample of 300 grams of meat was collected from 3 supermarkets, including pork, chicken, and beef. Samples were collected three times (April, June, and August), totaling 27 samples. Analysis included nonselective enrichment, selective enrichment, and selective plating. Confirmation involved: 1. Conventional method with Gram's staining, 2. Biochemical tests using triple sugar iron agar (TSI) and motility indole lysine medium (MIL), and 3. Conventional Polymerase Chain Reaction (cPCR) for genus and serovar confirmation.</p> <p><strong>Results</strong><strong>: </strong>From a total of 27 meat samples, 81 isolates of bacteria suspected to be <em>Salmonella</em> spp. were identified. Among these, confirmation tests revealed contamination with <em>Salmonella</em> spp. in 8 isolates (9.88%) of chicken meat samples. Upon further confirmation at the serovar level, 7 isolates (8.64%) were identified as <em>S.</em> Enteritidis. The study results indicate that the type of meat significantly affects the contamination levels of <em>Salmonella</em> spp. and <em>S.</em> Enteritidis, with statistical significance (<em>p</em> &lt; 0.05).</p> <p><strong>Conclusions</strong><strong>: </strong>In this study, <em>Salmonella</em> spp. was found from chicken samples and most of these isolates were confirmed to be <em>S. </em>enteritidis.</p> Santirat Thongphu Piyapong Choomsri Chantana Khensri Sasiwimon Sopawat Nakarin khamsunan Patcharee Pansa Chontichar Jinapon Copyright (c) 2025 Thai Food and Drug Journal https://creativecommons.org/licenses/by/4.0/ 2025-02-27 2025-02-27 32 1 33 46 https://he01.tci-thaijo.org/index.php/fdajournal/article/view/277540 <p><strong>Background:</strong> Identity testing is a crucial process that should be conducted on the pneumococcal conjugate vaccine to verify its identity for quality control purposes. The vaccine consists of purified polysaccharides from each serogroup of <em>Streptococcus pneumoniae</em>, conjugated with diphtheria cross-reactive material (CRM₁₉₇), as specified in the registration dossier. Therefore, this testing ensures that recipients can trust the quality, efficacy, and safety of the vaccine. The identity test of the pneumococcal conjugate vaccine is a newly developed identity testing method by the Institute of Biological Products.</p> <p><strong>Objective: </strong>To develop and validate a standard method for identity testing of pneumococcal polysaccharides and the CRM₁₉₇ carrier protein using the slot blot assay to verify the identity of the pneumococcal conjugate vaccine.</p> <p><strong>Methods:</strong> The optimum conditions were determined based on the specific reaction between the antigen and antibody, making them suitable for testing. Additionally, method validation was confirmed for two parameters including specificity and intermediate precision.</p> <p><strong>Results:</strong> The results of the optimum conditions for the identity test of pneumococcal polysaccharides and the carrier protein diphtheria Cross Reactive Material (CRM₁₉₇) in pneumococcal conjugate vaccines, using the slot blot assay, demonstrated that each antigen was specific to its corresponding serotype antibody, leading to the formation of an antigen-antibody complex. Therefore, this method must be performed according to the specified protocol to accurately verify the identity of the vaccine. Validation results revealed high specificity: pneumococcal conjugate vaccine samples displayed distinct dark purple bands, indicating positive identification, while meningococcal vaccine samples showed a negative result, represented by a white band on the nitrocellulose membrane. Furthermore, intermediate precision was confirmed by two independent analysts, both of them obtained consistent results. In both cases, dark purple bands appeared on the nitrocellulose membrane, indicating positive identification. Therefore, this method successfully passed validation and can be adopted as a standard procedure.</p> <p><strong>Conclusions: </strong>The study results revealed that the identity test for pneumococcal polysaccharides and the CRM₁₉₇ carrier protein using the slot blot assay met the validation requirements. Consequently, it is suitable for use as a standard method for the registration of the pneumococcal conjugate vaccine in Thailand.</p> Katsama Boonmak Supaporn Chumpol Supaporn Phumiamorn Copyright (c) 2025 Thai Food and Drug Journal https://creativecommons.org/licenses/by/4.0/ 2025-02-27 2025-02-27 32 1 47 59 https://he01.tci-thaijo.org/index.php/fdajournal/article/view/277541 <p><strong>Background: </strong>Rational Drug Use (RDU) is an urgent situation that requires rapid action. The RDU affects patient care in terms of treatment effectiveness, cost-effectiveness, safety, and drug adverse events, including the problem of antimicrobial resistance.</p> <p><strong>Objectives: </strong>To study the situation, develop a model and evaluate the model for promoting rational drug use with health care network in Chaturaphakphiman, Roi Et.</p> <p><strong>Methods: </strong>Participatory action research, consisted of a rational drug use committee and network. This research was conducted from October 2021 to September 2023 in 3 phases: the situation analysis phase, the model development phase, and the data evaluation phase. Collecting data by using the hospital indicator report, Health Data Center (HDC) database, and questionnaires for focus group discussions. Data were analysed using frequency, percentage, mean, standard deviation, and content analysis.</p> <p><strong>Results: </strong>The situation analysis phase found irrational drug use problems, such as antibiotic prescribing for normal labor full-term pregnancy, prescribing antibiotics in patients with small, uncontaminated wounds within 24 hours, prescribing domperidone for stimulating lactation in postpartum, duplicated prescribing of non-steroidal anti-inflammatory drugs (NSAIDs), lack of history taking and drug consumption in antenatal care (ANC), not following upper respiratory infection (URI) and diarrhea treatment guidelines, lack of patient education and advice, and lack of promoting community on how to take loperamide in diarrhea properly. The developed rational drug use promotion model consisted of factors on management, operation process, and operational efficiency. The data evaluation phase found that the development of the first cycle passed RDU level one, but there were problems related to overuse of antibiotics in URI, acute diarrhea, fresh wounds, and normal labor the second cycle passed RDU level two, but it found problems of prescribing metformin in diabetic patients that were &lt; 80%, and the third circle passed the RDU indicator level three.</p> <p><strong>Conclusions: </strong>The research suggested that the improved developed rational drug promotion model contributed to the achievement of promoting rational drug use in hospitals.</p> Prawut Lakhonrat Wipaporn Utama Copyright (c) 2025 Thai Food and Drug Journal https://creativecommons.org/licenses/by/4.0/ 2025-02-27 2025-02-27 32 1 60 76 https://he01.tci-thaijo.org/index.php/fdajournal/article/view/277543 <p><strong>Background: </strong>Development of a web application for medical supply management was an extension of the previous StockDB program, which no longer met the needs of increased usage volume. This could serve as a tool for managing medical supplies, responding to working conditions in procurement and dispensing of medical supplies to various units, controlling the value of medical supply disbursement, generating reports, and regulating the medical supply procurement to comply with the fiscal and financial management plan of the hospitals.</p> <p><strong>Objectives:</strong> To develop a web application for medical supply management and evaluate the acceptance of stakeholders in using the web application for managing the medical supplies.</p> <p><strong>Methods: </strong>This research was an action research conducted in one cycle, consisting of planning, implementation, observation of results, and reflection on results. A focus group discussion was conducted to review the problems and find the ways for developing a web application.&nbsp; Subsequently the application was developed and tested at Chiangkhan Hospital and the sub-district health promoting hospitals in Chiangkhan District, and was evaluated over a 2-month period.&nbsp; The research tools included questions for focus group discussion and the evaluation form for the acceptance of the web application usage.&nbsp; The data was collected from 12 web application developers and 61 users and evaluators in Chiangkhan District, Loei Province, from March to August 2024.</p> <p><strong>Results: </strong>The development of a web application for medical supply management was carried out through a literature review and focus group discussions regarding the stakeholders’ needs and development opportunities. The obtained information was used for planning and developing the web application, conducting the plan and observing the results. This led to the implementation at the local level and evaluated by users. The evaluation results from the target groups showed that 80.33% of the users were female with an average age of 36.72 years (S.D.=10.05). They were registered nurses (50.82%) and pharmacists/pharmacy technicians (21.31%), with a bachelor's degree of 83.61% and an average work experience of 13.90 years (S.D.=9.89). The assessment of acceptance in four dimensions included: 1) design and layout (high; Mean=4.20, S.D.=0.45), 2) efficiency/stability in use (highest; Mean=4.26, S.D.=0.38), 3) benefits to work (very high; Mean=4.31, S.D.=0.36), and 4) overall acceptance of use (highest; Mean=4.34, S.D.=0.51).</p> <p><strong>Conclusions: </strong>&nbsp;Developing a web application for medical supply management based on the information from literature review and focus group discussions resulted in more efficient, convenient and easy ways to manage drugs and medical supplies than using the previous program, in the aspects of selection, procurement, receipt inspection, control/storage, dispensing, reporting, and monitoring as well as the overall value of drug and medical supply management. The acceptance of the users was rated at the highest level.</p> Surawish Vilaskhamphir Sarawut Buaphuan Kaiyarach Hadthawaykan Copyright (c) 2025 Thai Food and Drug Journal https://creativecommons.org/licenses/by/4.0/ 2025-02-27 2025-02-27 32 1 77 93 https://he01.tci-thaijo.org/index.php/fdajournal/article/view/277612 Thanakrish Prasertsarn Copyright (c) 2025 Thai Food and Drug Journal https://creativecommons.org/licenses/by/4.0/ 2025-02-27 2025-02-27 32 1 3 4 https://he01.tci-thaijo.org/index.php/fdajournal/article/view/277534 Patcharaphun Kidpun Akanid Wapeewuttikorn Copyright (c) 2025 Thai Food and Drug Journal https://creativecommons.org/licenses/by/4.0/ 2025-02-27 2025-02-27 32 1 5 17