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Regulatory Framework And Challenges For Live Biotherapeutic Products In Taiwan, Shirley Pan, Jia-Chuan Hsu, Kuo-Teng Hung, Ching-Jung Ho 2025 Taiwan Food and Drug Administration, Ministry of Health and Welfare, Taipei, Taiwan

Regulatory Framework And Challenges For Live Biotherapeutic Products In Taiwan, Shirley Pan, Jia-Chuan Hsu, Kuo-Teng Hung, Ching-Jung Ho

Journal of Food and Drug Analysis

Products containing live microorganisms may be classified as food or drugs depending on their intended use; live biotherapeutic products (LBPs) with therapeutic claims are defined as medicinal products containing live bacteria or yeasts intended to prevent or treat disease. Based on their characteristics, LBPs are classified as biological drugs and must be registered as biological drugs before they can enter the Taiwanese market. As research into the microbiota and its role in health and disease continues to advance, LBPs are expected to play an increasingly important role in medicine and biotechnology. With the growing popularity of microbial applications in recent …


Aspergillosis: A Comprehensive Review Of Pathogenesis, Drug Resistance, And Emerging Therapeutics, AMANPREET SINGH, JEEWANJOT SINGH, SANDEEP KUMAR 2025 Department of pharmaceutics, Amar Shaheed Baba Ajit Singh Jujhar Singh Memorial College of Pharmacy, Bela, Ropar, Punjab 140111, India

Aspergillosis: A Comprehensive Review Of Pathogenesis, Drug Resistance, And Emerging Therapeutics, Amanpreet Singh, Jeewanjot Singh, Sandeep Kumar

Journal of Food and Drug Analysis

Aspergillosis stands as a primary opportunistic fungal infection which mainly results from Aspergillus fumigatus events that have gained more importance because of its multiple infection patterns and developing antifungal resistance. Healthcare providers identify two main ends of the aspergillosis spectrum which include allergic responses and invasive systemic infections that affect mainly immunocompromised subjects. This review presents a detailed summary for understanding the epidemiology of aspergillosis along with its risk factors as well as pathogenesis and host immune response and diagnostic difficulties. The analysis puts significant weight on increasing azole and echinocandin resistance that has become worse because of agricultural and …


Fda Approves Lecanemab-Irmb Maintenance Dosing For Early Alzheimer’S Disease Treatment, Jordyn Linfield, Giang Nguyen, Ashley Jacob, Andrew Johnson, Maria Nguyen, Sara Ha, Joshua Honaker, Samantha McCord, Kelly Kroustos 2025 Ohio Northern University

Fda Approves Lecanemab-Irmb Maintenance Dosing For Early Alzheimer’S Disease Treatment, Jordyn Linfield, Giang Nguyen, Ashley Jacob, Andrew Johnson, Maria Nguyen, Sara Ha, Joshua Honaker, Samantha Mccord, Kelly Kroustos

Pharmacy and Wellness Review

Alzheimer’s disease (AD) is the most prevalent neurodegenerative disorder and is associated with progressive and irreversible cognitive decline that begins with memory lapses leading to physical and functional impairment. The conventional therapies that have been used for the treatment from Alzheimer's Disease include acetylcholinesterase inhibitors and memantine, but additional therapy options are being developed. Lecanemab, brand name Lequembi, is currently a Food and Drug Administration (FDA) approved humanized monoclonal antibody for the treatment of Alzheimer’s disease and indicated for mild cognitive impairment (MCI) or mild dementia. While there is impactful aid for treatment, lecanemab has three significant adverse reactions, which …


The Possible Cardioprotectiveeffect Of Empagliflozin During Endotoxemia In Mice Model, Safwa Miqdad Al-killidar, Bashaer M. Muhammad-Baqir 2025 Master student in Department of pharmacology and toxocology - from Kufa university /faculty of pharmacy, Iraq.

The Possible Cardioprotectiveeffect Of Empagliflozin During Endotoxemia In Mice Model, Safwa Miqdad Al-Killidar, Bashaer M. Muhammad-Baqir

Maaen Journal for Medical Sciences

Background:Sepsis is a major complication for seriously ill people with shock, major infections, serious burns, or severe trauma. Inflammation imbalance is the primary underlying cause of sepsis progression and persists continuously over the entire sepsis course. Empagliflozin is an orally administered medication for diabetes that selectively inhibits sodium-glucose cotransporter 2 to improve kidney elimination of glucose. It has been discovered that sodium-glucose cotransporter 2 exhibit anti inflammation and multiple effects, suggesting that they may be beneficial and prevent infections. Aim of study:This study was undertaken to assess Empagliflozin's cardioprotective efficacy in septic mice through its potent anti- inflammatory …


The Role Of G6pd Variants And 3d Genomic Structure In The Development Of Pulmonary Hypertension, Christina M. Signoretti Ph.D. 2025 New York Medical College

The Role Of G6pd Variants And 3d Genomic Structure In The Development Of Pulmonary Hypertension, Christina M. Signoretti Ph.D.

NYMC Student Theses and Dissertations

Pulmonary hypertension is an under-recognized global health epidemic which is estimated to affect 1% of the population. It is associated with sustained mean pulmonary artery pressure greater than 20 mmHg, pulmonary artery remodeling, smooth muscle and endothelial cell proliferation and subsequent increased right ventricle hypertrophy due to increased afterload. Glucose-6-phosphate dehydrogenase (G6PD) is one of the key enzymes in the pentose phosphate pathway and has been previously linked to the development of pulmonary hypertension. G6PD deficiency is the most common human enzymopathy which affects approximately 400 million people worldwide and is a result of agricultural and epidemiological evolution in different …


Misused And Misunderstood: Examining The Inappropriate Use Of Stimulant Medications, Connor Dains, Madilyn Paphanchith, Makayla Eversole, Chaehyeon Jin, Minhwan Yang, Joshua Honaker, Samantha McCord, Kayla Petkus 2025 Nationwide Children's Hospital

Misused And Misunderstood: Examining The Inappropriate Use Of Stimulant Medications, Connor Dains, Madilyn Paphanchith, Makayla Eversole, Chaehyeon Jin, Minhwan Yang, Joshua Honaker, Samantha Mccord, Kayla Petkus

Pharmacy and Wellness Review

Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder in children, characterized by inattention, hyperactivity, and impulsivity. The American Academy of Pediatrics (AAP) endorses stimulant medications as the first-line treatment option. When combined with behavioral therapy, this pharmacologic class can improve focus, executive functioning, and the overall quality of life. While stimulant prescriptions can have a positive effect when used as directed, there is concern for the potential of provider overprescription and patient misuse related to these medications. Consequently, the Food and Drug Administration (FDA) revised the boxed warning and prescribing information for stimulant medications. Healthcare providers must educate …


Variability In Methotrexate Metabolites In A Cohort Of Jia Patients, Nuria Lara Castillo, Mara Becker, Marc Sudman, Susan Thompson, Laura Ramsey 2025 Children's Mercy Kansas City

Variability In Methotrexate Metabolites In A Cohort Of Jia Patients, Nuria Lara Castillo, Mara Becker, Marc Sudman, Susan Thompson, Laura Ramsey

Research Days

Background: Methotrexate (MTX) is the cornerstone disease-modifying anti-rheumatic drug for the treatment of Juvenile Idiopathic Arthritis (JIA). While most patients receiving MTX have a favorable outcome, approximately 30% do not respond, and several experience toxic events, suggesting interindividual difference. Furthermore, evaluation of MTX response takes several months, with the risk of missing the early “window of opportunity” for treatment. Predicting MTX response prior to administration would greatly benefit these patients and their treating physicians by saving valuable time during the early stages of the disease onset. MTX is a folate antagonist and, similar to folate, it undergoes polyglutamation inside the …


Fc Gamma Receptors Facilitate Antigenic Modulation Of Lilrb4 And Function As Predictive Biomarkers In Acute Monocytic Leukemia, Joshua Morse 2025 University of Texas Health Science Center at Houston

Fc Gamma Receptors Facilitate Antigenic Modulation Of Lilrb4 And Function As Predictive Biomarkers In Acute Monocytic Leukemia, Joshua Morse

Dissertations and Theses (Open Access)

Acute monocytic leukemia (monocytic AML) is a subtype of AML marked by a proliferation of abnormal monoblasts. This subtype represents approximately 10% of AML cases. The prognosis of monocytic AML is poor, with a 5-year survival of ~30%. Most patients are diagnosed at an age when they are unlikely to survive first-line non-targeted cytotoxic chemotherapy as a bridge to hematopoietic stem cell transplant (HSCT). Even patients who achieve remission commonly relapse. This population of patients would greatly benefit from precision-targeted therapies but currently there are none approved for monocytic AML.

Leukocyte immunoglobulin-like receptor B4 (LILRB4) is an immune checkpoint expressed …


Investigating Prefrontal Cortex Neuronal Signatures Of Opioid-Induced Risk-Taking Behavior, Cana Quave 2025 University of Texas Health Science Center at Houston

Investigating Prefrontal Cortex Neuronal Signatures Of Opioid-Induced Risk-Taking Behavior, Cana Quave

Dissertations and Theses (Open Access)

Opioid use disorder occurs alongside impaired risk-related decision-making, but the underlying neural correlates are unclear. We developed an approach-avoidance conflict task using a modified conditioned place preference procedure to study neural signals of risky opioid seeking in the prefrontal cortex, a region implicated in executive decision-making. Following morphine conditioned place preference, rats underwent a conflict test in which fear-inducing cat odor was introduced in the previously drug-paired side of the apparatus. While the saline-exposed control group avoided cat odor, the morphine group included two subsets of rats that either maintained a preference for the paired side despite the presence of …


Investigating The Role Of The Hypocretin/Orexin System In A Novel Model Of Polysubstance Dependence, Tyler Zarin 2025 East Tennessee State University

Investigating The Role Of The Hypocretin/Orexin System In A Novel Model Of Polysubstance Dependence, Tyler Zarin

Electronic Theses and Dissertations

Substance use disorders (SUD) in the United States are steadily increasing. Potent and dangerous substances such as methamphetamine (MA) and fentanyl (FEN) are often co-used as a polysubstance (POLY), either intentionally or unknowingly as FEN is a common adulterant. SUD is characterized by physiological and psychological dependence involving the negative reinforcement of anhedonia and withdrawal which drive hypermotivated drug-taking behaviors. Current theory suggests that recruitment of hypocretin/orexin (HCRT) neuropeptide in reward and stress associated brain regions contributes to drug dependence. Despite strong evidence for HCRT’s role in mono-drug dependence, a relevant model for POLY dependence has yet to be developed, …


Assessing The Behavioral Impact Of Pyridostigmine Bromide In Rats, Noah A. Martin 2025 Mississippi State University

Assessing The Behavioral Impact Of Pyridostigmine Bromide In Rats, Noah A. Martin

Honors Theses

Pyridostigmine bromide (PB) is an organophosphate (OP) nerve agent prophylactic used to protect warfighters against chemical warfare agents. OPs inhibit the neural enzyme acetylcholinesterase (AChE) in the brain. This leads to the buildup of acetylcholine, causing respiratory failure, seizures, and death. PB functions by inhibiting ~30% of peripheral AChE temporarily, protecting the enzymes so that the body is able to restore sufficient cholinergic function post-exposure. PB does not cross the blood-brain barrier, though it may still indirectly affect toxicity in the brain due to repeated AChE inhibition throughout treatment, or by inhibition of non-target ChE’s in the blood. The aim …


5-Ht Receptors: Pharmacology And Functional Selectivity, Benjamin R. Cummins, Gerald B. Billac, David E. Nichols, Charles D. Nichols 2025 LSU Health Sciences Center - New Orleans

5-Ht Receptors: Pharmacology And Functional Selectivity, Benjamin R. Cummins, Gerald B. Billac, David E. Nichols, Charles D. Nichols

School of Medicine Faculty Publications

Serotonin 5-HT receptors were one of the first serotonin receptors to be pharmacologically characterized. In mammals, they are expressed throughout the body in nearly every cell and tissue type, with the highest density in cortical layer V of the brain. They are involved in several aspects of normal physiological processes and behaviors and have been implicated in the etiology of neuropsychiatric diseases such as schizophrenia. Atypical antipsychotics have targeted blockade of 5-HT receptors as part of their therapeutic mechanism. More recently, 5-HT receptors have come to prominence for their role as the primary target for psychedelic drugs, which activate this …


Psilocybin Impairs The Extinction Of Contextual Fear In Adult Female, But Not Male, Rats, Lillianna P. Puppel, Aleece K. Al-Olimat, Kylie M. King, Marisa J. Savini, Claire E. Miller, Colin R. Del Valle, Heather R. Sparkman, Brooke E. Bramlage, Phillip R. Zoladz 2025 Ohio Northern University

Psilocybin Impairs The Extinction Of Contextual Fear In Adult Female, But Not Male, Rats, Lillianna P. Puppel, Aleece K. Al-Olimat, Kylie M. King, Marisa J. Savini, Claire E. Miller, Colin R. Del Valle, Heather R. Sparkman, Brooke E. Bramlage, Phillip R. Zoladz

ONU Student Research Colloquium

Fear-related disorders are often treated with exposure therapy, a technique based on the concept of extinction. However, this type of therapy is ineffective for many individuals, so finding a pharmacological adjunct that augments the extinction of fear could lead to better treatment outcomes. In recent preclinical work, investigators have shown that psychedelics can accelerate the extinction of fear, potentially through their impact on neurotrophic signaling. We previously found that psilocybin exerted sex-dependent effects on the extinction of conditioned fear to an isolated cue (i.e., a tone). Specifically, psilocybin enhanced the extinction of cue fear in male rats but impaired it …


The Pharmaceutical Applications Of Poisonous Compounds Found In Datura Stramonium, Ruby M. Raffaldt 2025 University of South Carolina - Columbia

The Pharmaceutical Applications Of Poisonous Compounds Found In Datura Stramonium, Ruby M. Raffaldt

Senior Theses

Datura stramonium is a plant that is known for its toxicity. However, a facet of this plant’s noxious chemicals, namely its tropane alkaloids, can be used medicinally. The aim of this paper was to compile knowledge on the botanical, chemical, and medicinal properties of Datura stramonium L with a focus on atropine, scopolamine, and anisodamine; three tropane alkaloid compounds with the ability to be both a poison and a medicine. Information was compiled using pre-existing studies, articles, and literature reviews on D. stramonium. For each of the three alkaloids, their biosynthetic pathways, targets, administration, distribution, metabolism, and excretion were discussed. …


Enhancing Topical Drug Delivery Of Apremilast Through Niosomal Gel Formulation: Ex Vivo Skin Permeation And In Vivo Evaluation For Psoriasis, Megha Shyam Matlapudi, Anka Rao Areti, Yukti Jaiswal, Veeresh Bantal, Raghavender Medishetti 2025 Department of Pharmacy, K L College of Pharmacy, Koneru Lakshmaiah Educational Foundation, Green Fields, Vaddeswaram, Guntur, Andhra Pradesh, India

Enhancing Topical Drug Delivery Of Apremilast Through Niosomal Gel Formulation: Ex Vivo Skin Permeation And In Vivo Evaluation For Psoriasis, Megha Shyam Matlapudi, Anka Rao Areti, Yukti Jaiswal, Veeresh Bantal, Raghavender Medishetti

The Thai Journal of Pharmaceutical Sciences

Background: Psoriasis is a dynamic and chronic disease characterized by inflammatory changes and an increased rate of keratinocyte proliferation leading to the formation of erythematous scleroderma plaques with a silvery sheen. The existing therapies come with shortcomings in terms of effectiveness and leave behind a trail of side effects. Hence, there is a need of alternative therapeutic measures. Objectives: This study aimed to assess the therapeutic potential of Apremilast Niosomal Gel (APR Nio Gel) in treating psoriasis, comparing its effectiveness with conventional gel (APR Gel) and oral suspension (APR Oral) formulations. Materials and Methods: Apremilast niosomes were prepared by thin …


Bacillus Coagulans 198 And L-Glutamine In Combination Attenuated Intestinal Mucositis In A 5-Fu-Induced Balb/C Mouse Model Via Modulation Of Gut Microbial Community Structure And Diversity, Wei-Jen Chen, Siou-Ru Shen, Wei-Hsuan Hsu, Bao-Hong Lee, Yu-Shan Wei, Hui-Fang Chu, Ming-Chung Tseng, Tang-Long Shen 2025 Research and Development Department, Syngen Biotech Co., Ltd., Tainan, Taiwan

Bacillus Coagulans 198 And L-Glutamine In Combination Attenuated Intestinal Mucositis In A 5-Fu-Induced Balb/C Mouse Model Via Modulation Of Gut Microbial Community Structure And Diversity, Wei-Jen Chen, Siou-Ru Shen, Wei-Hsuan Hsu, Bao-Hong Lee, Yu-Shan Wei, Hui-Fang Chu, Ming-Chung Tseng, Tang-Long Shen

Journal of Food and Drug Analysis

5-Fluorouracil (5-FU) disrupts intestinal cells and causes dysbiosis in the gut microbiota. This study explores the potential of Bacillus coagulans-198 (BC198) to mitigate gut microbiota imbalance and mucositis caused by 5-fluorouracil. L-glutamine is used to alleviate mucositis, and this study found that BC198 exhibits protective effects on the gut, including maintaining a healthy microbiota and reducing intestinal inflammation, regardless of whether L-glutamine is used in combination. Therefore, it can help reduce the deterioration of the gut environment caused by 5-fluorouracil. BC198 can be provided to cancer patients to prevent severe side effects, thereby improving their treatment outcomes and nutritional …


Protective Role Of Hsian-Tsao Ethanol Extract Against Body Fat, Serum Lipid Profiles, And Hepatic Lipid Profiles In High-Fat Diet-Fed Rats, Ching-Chang Cho, Gow-Chin Yen, Hsin-Yi Lee, Chun-Tse Tsai, Wei-Tang Chang, Chin-Lin Hsu 2025 Department of Nutrition, Chung Shan Medical University, Taichung, Taiwan

Protective Role Of Hsian-Tsao Ethanol Extract Against Body Fat, Serum Lipid Profiles, And Hepatic Lipid Profiles In High-Fat Diet-Fed Rats, Ching-Chang Cho, Gow-Chin Yen, Hsin-Yi Lee, Chun-Tse Tsai, Wei-Tang Chang, Chin-Lin Hsu

Journal of Food and Drug Analysis

This study investigated the preventive effects of a 40% ethanol extract of Hsian-tsao (40EEHT) on obesity in high-fat diet (HFD)-induced obese rats. Male Wistar rats were administered 0, 100, 200, or 500 mg/kg of 40EEHT, resulting in reduced body weight, total body fat, and hepatic tissue weight after 8 weeks. 40EEHT also decreased adipocyte size, improved lipid profiles, alleviated oxidative stress, and enhanced hepatic antioxidant enzyme activities. Additionally, it regulated fatty acid metabolism by reducing lipogenesis and increasing lipolysis and β-oxidation, suggesting its potential as an anti-obesity dietary supplement.


Xanthohumol As A Potential Therapeutic Strategy For Acute Myeloid Leukemia: Targeting The Flt3/Srpk1 Signaling Axis, Duan-Na Zhang, Wen-Ya Yang, Xiao-Xue Hu, Xiao-Min-Ting Song, Chuan-Jie Guo, Fu Peng, Yu-Zhi Li, Zhi-Xing Cao 2025 The State Key Laboratory of Southwest Chinese Medicine Resources, School of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu, 611137, China

Xanthohumol As A Potential Therapeutic Strategy For Acute Myeloid Leukemia: Targeting The Flt3/Srpk1 Signaling Axis, Duan-Na Zhang, Wen-Ya Yang, Xiao-Xue Hu, Xiao-Min-Ting Song, Chuan-Jie Guo, Fu Peng, Yu-Zhi Li, Zhi-Xing Cao

Journal of Food and Drug Analysis

Xanthohumol (XN) is an isoprene chalcone found in hops (Humulus lupulus L.), a food ingredient with a wide range of pharmacological activities. The aim of this study was to reveal the therapeutic effect of XN on acute myeloid leukemia (AML) and the potential underlying molecular mechanism. Through network pharmacology analysis, molecular docking, and HTRF determination, XN was shown to inhibit the kinase activities of FLT3 and SRPK1 by targeting their ATP-binding domains, with IC50 values of 1.51 ± 0.44 μM and 0.37 ± 0.15 μM, respectively. By inhibiting AML cell proliferation, promoting apoptosis, regulating autophagy, and inhibiting …


Within-Trial Cost-Effectiveness Of Novel Macrophage-Regulating Treatment On Wound Healing In Patients With Diabetic Foot Ulcers, Hsuan-Yu Su, Chen-Yi Yang, Yi-Hsin Chang, Shyi-Gen Chen, Jui-Ching Chen, Hui-Ju Ho, Huang-Tz Ou, Shihchen Kuo 2025 Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan

Within-Trial Cost-Effectiveness Of Novel Macrophage-Regulating Treatment On Wound Healing In Patients With Diabetic Foot Ulcers, Hsuan-Yu Su, Chen-Yi Yang, Yi-Hsin Chang, Shyi-Gen Chen, Jui-Ching Chen, Hui-Ju Ho, Huang-Tz Ou, Shihchen Kuo

Journal of Food and Drug Analysis

An M1/M2 macrophage-regulating treatment, ON101 cream, has shown its superior healing efficacy for diabetic foot ulcers (DFUs) versus standard absorbent dressing, according to a phase Ⅲ trial. Given its high cost, corroborating the economic value of ON101 treatment can facilitate clinical and policy decision-makings. This study sought to evaluate the cost-effectiveness of ON101 versus an absorbent dressing for patients with DFUs from Taiwan's healthcare sector perspective. This economic evaluation utilized effectiveness and cost data (in 2022 USD) from a randomized controlled trial of ON101, published literature, and Taiwan’s National Health Insurance program. Incremental cost-effectiveness ratio (ICER) against willingness-to-pay (WTP) threshold …


Method Development For The Determination Of Phosphine Residues In Foods, Shu-Wei Lin, Yu-Ting Liu, Ya-Chun Chou, Yu-Ching Hung, Shu-Han Chang, Ya-Min Kao, Su-Hsiang Tseng, Der-Yuan Wang 2025 Division of Research and Analysis, Taiwan Food and Drug Administration, MOHW, Taipei 11561, Taiwan, ROC

Method Development For The Determination Of Phosphine Residues In Foods, Shu-Wei Lin, Yu-Ting Liu, Ya-Chun Chou, Yu-Ching Hung, Shu-Han Chang, Ya-Min Kao, Su-Hsiang Tseng, Der-Yuan Wang

Journal of Food and Drug Analysis

Phosphine (PH3) is a fumigant used for pest control of stored products and foods. In Taiwan, PH3 has the maximum residue level (MRL) in 14 foods, including dried fruits, vegetables, spices, nuts, crops, roots, and tuber vegetables. In this study, gas chromatography/mass spectrometry coupled with a headspace sampler (HS-GC/MS) was used to determine the PH3 content in foods. The stability of the PH3 standard was evaluated either directly using the gas standard or indirectly using zinc phosphide (Zn3P2) with an acid. The optimal conditions for the headspace agitator were determined to …


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