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Regulatory Considerations For Generic Products Of Non-Biological Complex Drugs, Yu-Hsuan Liu, Yi-Shuo Chen, Ting Tseng, Min-Lin Jiang, Churn-Shiouh Gau, Lin-Chau Chang 2023 School of Pharmacy, College of Medicine, National Taiwan University, Taipei City, Taiwan, R.O.C.

Regulatory Considerations For Generic Products Of Non-Biological Complex Drugs, Yu-Hsuan Liu, Yi-Shuo Chen, Ting Tseng, Min-Lin Jiang, Churn-Shiouh Gau, Lin-Chau Chang

Journal of Food and Drug Analysis

The Non-Biological Complex Drug (NBCD) Working Group defines an NBCD as “a medicinal product, not being a biological medicine, where the active substance is not a homo-molecular structure, but consists of different (closely related and often nanoparticulate) structures that cannot be isolated and fully quantitated, characterized and/or described by physicochemical analytical means”. There are concerns about the potential clinical differences between the follow-on versions and the originator products and within the individual follow-on versions. In the present study, we compare the regulatory requirements for developing generic products of NBCDs in the European Union (EU) and the United States (US). The …


Recent Developments In Detection And Therapeutic Approaches For Antibiotic-Resistant Bacterial Infections, Kavya Moorthy, Kai-Chih Chang, Hsueh-Hui Yang, Wen-Min Su, Cheng-Kang Chiang, Zhiqin Yuan 2023 Department of Chemistry, National Dong Hwa University, Taiwan, R.O.C.

Recent Developments In Detection And Therapeutic Approaches For Antibiotic-Resistant Bacterial Infections, Kavya Moorthy, Kai-Chih Chang, Hsueh-Hui Yang, Wen-Min Su, Cheng-Kang Chiang, Zhiqin Yuan

Journal of Food and Drug Analysis

Owing to the widespread emergence and proliferation of antibiotic-resistant bacteria, the therapeutic benefits of antibiotics have been reduced. In addition, the ongoing evolution of multidrug-resistant pathogens poses a challenge for the scientific community to develop sensitive analytical methods and innovative antimicrobial agents for the detection and treatment of drug-resistant bacterial infections. In this review, we have described the antibiotic resistance mechanisms that occur in bacteria and summarized the recent developments in detection strategies for monitoring drug resistance using different diagnostic methods in three aspects, including electrostatic attraction, chemical reaction, and probe-free analysis. Additionally, to understand the effective inhibition of drug-resistant …


The Effects Of Salinity And Acetaminophen On The Aquatic Snail Physa Acuta, Michelle Sackey-Ansah, Megan Mackey, Daniel Elias, Jason Doll, Alyssa Brookhart 2023 North Carolina Wesleyan University

The Effects Of Salinity And Acetaminophen On The Aquatic Snail Physa Acuta, Michelle Sackey-Ansah, Megan Mackey, Daniel Elias, Jason Doll, Alyssa Brookhart

Journal of the South Carolina Academy of Science

Pharmaceuticals are increasingly detected in water bodies, and their presence can negatively impact aquatic organisms. This effect can be amplified when combined with increasing salinity in freshwater ecosystems. Acetaminophen is a widely used analgesic that is commonly found in river, streams, and waters where it is discharged directly. Therefore, organisms present in these locations (e.g., insects, snails, amphibians, and fish) are likely to be affected by acetaminophen. In this study, we determined the effects of elevated salinity (0.68 g/L), acetaminophen (500 µg/L) and combined elevated salinity (0.68 g/L) and acetaminophen (500 µg/L), on the growth, reproduction, and movement of the …


Phase 1a Clinical Study For Q-Griffithsin Intranasal Spray For Prevention Of Coronavirus, Megan Bezold, Kenneth Palmer, Nobuyuki Matoba, Elizabeth Cash 2023 University of Louisville

Phase 1a Clinical Study For Q-Griffithsin Intranasal Spray For Prevention Of Coronavirus, Megan Bezold, Kenneth Palmer, Nobuyuki Matoba, Elizabeth Cash

Posters-at-the-Capitol

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a highly transmissible virus that causes acute respiratory disease with possible long-term complications, known as coronavirus disease 2019 (COVID-19). Griffithsin (GRFT; including the oxidation-resistant variant Q-GRFT used in this study) is an algal carbohydrate-binding protein exhibiting antiviral effects against many enveloped viruses, including all major variants of SARS- CoV-2 reported to date. Q-GRFT has been recombinantly manufactured in Nicotiana benthamiana plants, thoroughly purified, and formulated as an intranasal spray designed to be developed as a non-vaccine broad-spectrum prophylactic product for acute use. This is the first-in-human, randomized, double-blind, placebo-controlled study. The …


Mancozeb Exposure Results In Oxidative Stress And Disruption Of Mitochondrial Complexes Iii & Iv In Transformed Human Colon Cells, Amanda Dhaneshwar 2023 Saint John's University, Jamaica New York

Mancozeb Exposure Results In Oxidative Stress And Disruption Of Mitochondrial Complexes Iii & Iv In Transformed Human Colon Cells, Amanda Dhaneshwar

Theses and Dissertations

The ethylene bisdithiocarbamate pesticides, a subclass of the dithiocarbamate pesticides, are broad spectrum organometallic fungicides used on a variety of crops. The fungicide Mancozeb is comprised of an ethylene bisdithiocarbamate backbone complexed to the metals manganese and zinc. Ingestion of food containing pesticide residue and occupational exposure are common routes of Mancozeb exposure. Previous work demonstrated that Mancozeb exposure to HT-29 colon cancer cells resulted in cytotoxicity, apoptosis, and disruption of mitochondrial complex I, II, and V activity. The current study investigated the effect of Mancozeb exposure on mitochondrial complex III and IV activity and oxidative stress parameters in the …


Growth And Survival Of Amphibians Exposed To Road Salt And Glyphosate-Based Herbicide, Jerica Eaton 2023 Western Kentucky University

Growth And Survival Of Amphibians Exposed To Road Salt And Glyphosate-Based Herbicide, Jerica Eaton

Mahurin Honors College Capstone Experience/Thesis Projects

Amphibian populations are threatened by increasing levels of environmental pollution resulting from human activities. Areas with mixed land use that include agriculture and urban development experience increased contamination from surface herbicide and road deicer application. Upon entering water sources, these chemicals have the capacity to disrupt the natural dynamics of aquatic ecosystems. This study aimed to evaluate the effects of these contaminants on amphibian populations. I used the spotted salamander (Ambystoma maculatum) as a model, rearing larvae from hatching to metamorphosis. I subjected larvae in each of the treatment groups to varying levels of herbicide and salt concentrations. …


Telomeres: A Tool To Assess The Impacts Of Mining Contaminants On Riparian Songbirds, Lillian Krach, Bridger Creel, Megan Fylling, Zac Cheviron, Creagh Breuner 2023 The University of Montana

Telomeres: A Tool To Assess The Impacts Of Mining Contaminants On Riparian Songbirds, Lillian Krach, Bridger Creel, Megan Fylling, Zac Cheviron, Creagh Breuner

Undergraduate Theses, Professional Papers, and Capstone Artifacts

Mining has left massive environmental and physical scars across the landscape. Aquatic and riparian landscapes in particular have been significantly impacted by traditional mining practices. Waste products left over from hard-rock mining leech heavy metals onto the landscape and these metals spread from headwater streams to major waterways (Lottermoser 2010). Heavy metals have been shown to cause physiological stress and challenges to organisms depending on the metal and the concentration (Baos et al. 2019, Boyd & Rajakaruna 2013). While some mining-impaired areas have undergone restoration efforts, is it enough? Typical restoration methods replace the contaminated floodplain, but not the riverbed …


Characterizing The Effects Of Antiandrogens And Senolytics To Enhance The Therapeutic Response To Castration-Resistant Prostate Cancer, Justin M. Silverman 2023 Virginia Commonwealth University

Characterizing The Effects Of Antiandrogens And Senolytics To Enhance The Therapeutic Response To Castration-Resistant Prostate Cancer, Justin M. Silverman

Theses and Dissertations

Prostate cancer is the most frequently diagnosed cancer in males and the second most common cause of cancer deaths. Androgen deprivation therapy, whether through surgical or chemical castration, is the mainstay for treatment of advanced prostate cancer; however, despite an initial response, most patients eventually develop a progressive PSA rise, and castration- sensitive prostate cancer gives rise to castration-resistant prostate cancer. The standard of care therapy includes the antiandrogens such as enzalutamide and abiraterone acetate as well as the microtubule poison, docetaxel, and various immunotherapies; however, while prostate cancer research is progressing, there continues to be a compelling need for …


Inferring Exposure To Harmful Pseudo-Nitzschia Blooms From Ocean-To-Estuary Gradients In Domoic Acid Concentrations In Humboldt Bay Bivalves, Natasha Hope Ficzycz Winnacott 2023 Cal Poly Humboldt

Inferring Exposure To Harmful Pseudo-Nitzschia Blooms From Ocean-To-Estuary Gradients In Domoic Acid Concentrations In Humboldt Bay Bivalves, Natasha Hope Ficzycz Winnacott

Cal Poly Humboldt theses and projects

Harmful algal blooms (HABs) result from outbreaks of any of several different species of toxin-producing phytoplankton and that can have major detrimental effects on marine ecosystems and pose severe health and economic threats to human communities. Of particular concern along the United States West Coast are HABs of pennate diatom genus Pseudo-nitzschia that produce the potent neurotoxin domoic acid (DA). The coastal ocean between Cape Mendocino, CA, and Cape Blanco, OR is a hotspot for Pseudo-nitzschia spp. HABs. Such blooms impact coastal fisheries and pose a potential threat to aquaculture operations in Humboldt Bay, California’s second largest estuary and largest …


Acute Copper (Cu) Toxicity In Dragonfly Naiads (Insecta: Odonata), Jeff M. Simpson 2023 University of Nebraska-Lincoln

Acute Copper (Cu) Toxicity In Dragonfly Naiads (Insecta: Odonata), Jeff M. Simpson

Department of Entomology: Distance Master of Science Projects

The objective of this study was to examine the effects copper (Cu) on mortality within a pair of test groups of naiads in the order Odonata, and to replicate previous observations regarding their potential uses as indicators for water quality. Few past studies have examined toxicity within relation to the odonates. It has been suggested that this order may contain valuable model organisms (Tollett et al., 2008). Very little focus has been given to odonates as bioindicators, with the few studies done being performed on species that would typically inhabit lentic environments (Trevino, 1999). Similarly, the test subjects for this …


Revisiting The 2018 Corsica Oil Spill - A Preliminary Case Study Of Ecosystem Recovery From Pahs In Yelkouan Shearwater (Puffinus Yelkouan), Makenna Mahrer 2023 Claremont McKenna College

Revisiting The 2018 Corsica Oil Spill - A Preliminary Case Study Of Ecosystem Recovery From Pahs In Yelkouan Shearwater (Puffinus Yelkouan), Makenna Mahrer

CMC Senior Theses

Polycyclic aromatic hydrocarbons (PAHs) are a specific class of persistent organic pollutants (POPs) heavily associated with crude oil, and pose genotoxic and physiological threats to marine life when released into the aquatic environment during a petroleum spill. This study seeks to understand the residual impacts of the 2018 Corsica oil spill on Puffinus yelkouan (Yelkouan Shearwater), a seabird endemic to the Mediterranean basin, using the species as a bioindicator for contamination in the region. Though classified by the IUCN Red List as ‘vulnerable,’ this species remains grossly understudied in present monitoring literature. This study made use of blood samples and …


Bioaccumulation Of Polychlorinated Biphenyl Compounds And Mercury In A Mining Impacted Aquatic Ecosystem, Michelle Bollini 2023 Michigan Technological University

Bioaccumulation Of Polychlorinated Biphenyl Compounds And Mercury In A Mining Impacted Aquatic Ecosystem, Michelle Bollini

Dissertations, Master's Theses and Master's Reports

The Keweenaw area continues to be influenced by the century of copper mining that ended nearly 50 years ago. This project is focused on Torch Lake, an aquatic ecosystem that has been heavily impacted by mining waste disposal. The watershed has been impaired by mine discharge and tailings, smelter and smokestack plumes, and poor waste disposal practices. The lake is listed as a Great Lakes Area of Concern with beneficial use impairments of restrictions on fish consumption and a degraded benthic community. Polychlorinated biphenyl compounds (PCBs) and methylmercury (MeHg) are persistent, bioaccumulative, and toxic substances (PBTs). These contaminants pose threats …


Cytotoxicity And Reproductive Impairment In Rainbow Trout Cell Lines Exposed To Microcystis Aeruginosa Extracellular Metabolites, Keira Harshaw 2023 University of Windsor

Cytotoxicity And Reproductive Impairment In Rainbow Trout Cell Lines Exposed To Microcystis Aeruginosa Extracellular Metabolites, Keira Harshaw

Electronic Theses and Dissertations

Current trends in cyanobacterial harmful algal blooms (cHABs) demonstrate increasing risks to human health and the health of aquatic ecosystems around the globe. Expansion of algal blooms, both geographically and temporally, serve to place increasing numbers of freshwater species, including fish, in peril. Microcystis aeruginosa, one of the most common species of bloom-causing cyanobacteria, is capable of producing a vast diversity of biologically active compounds, however Microcystis studies are often dominated by microcystins. How non-microcystin metabolites contribute to Microcystis toxicity, particularly in freshwater fish, has been the subject of a limited, but growing, body of research. To contribute to …


Promoting Healthier Treatment Outcomes In Obese Cancer Patients Taking High Dose Methotrexate, Carly Dell'Ova 2023 Walden University

Promoting Healthier Treatment Outcomes In Obese Cancer Patients Taking High Dose Methotrexate, Carly Dell'ova

Walden Dissertations and Doctoral Studies

Cancer and obesity rates continue to rise, creating enormous public heath burdens to the individual and at the national and global levels, reducing quality of life, and increasing spending. Moreover, the relationships between cancer and obesity are not well understood. A commonly used chemotherapy for several types of cancer is high dose methotrexate (HDMTX). Along with chemotherapy, especially at high doses, comes toxicity to specific organs and the entire body. However, limited research has been conducted on obese cancer patients as they are often excluded from clinical studies. Practitioners need to better understand how to dose these patients to provide …


Assessment Of Spilled Toxic Bait By Wild Pigs And Potential Risk To Non-Target Species, John C. Kinsey, Justin A. Foster, Nathan P. Snow, Jason D. Wishart, Linton D. Staples, Janis K. Bush, Kurt V. VerCauteren 2023 Texas Parks and Wildlife Department

Assessment Of Spilled Toxic Bait By Wild Pigs And Potential Risk To Non-Target Species, John C. Kinsey, Justin A. Foster, Nathan P. Snow, Jason D. Wishart, Linton D. Staples, Janis K. Bush, Kurt V. Vercauteren

USDA Wildlife Services: Staff Publications

Background

In 2018, a sodium nitrite (SN)-based toxic bait for invasive wild pigs (hereafter wild pigs; Sus scrofa), was evaluated to determine its effectiveness in reducing local wild pig populations in Texas. Localized population reductions of > 70% were achieved, but spillage of bait outside wild pig-specific feeders (bait stations) caused by feeding wild pigs resulted in the deaths of non-target animals. To evaluate risks to non-target animals, we tested whether bait presentation influenced the total amount of bait spilled by wild pigs and estimated the associated risk to non-target species.

Results

We found that bait spilled outside bait stations …


Halogen Bonding Interactions Of Haloaromatic Endocrine Disruptors And The Potential For Inhibition Of Iodothyronine Deiodinases, Craig A. Bayse 2023 Old Dominion University

Halogen Bonding Interactions Of Haloaromatic Endocrine Disruptors And The Potential For Inhibition Of Iodothyronine Deiodinases, Craig A. Bayse

Chemistry & Biochemistry Faculty Publications

Halogen bonding (XB) is a potential mechanism for the inhibition of the thyroid-activating/deactivating iodothyronine deiodinase family of selenoproteins through interactions with halogenated endocrine disrupting compounds (EDCs). Trends in XB interactions were examined using density functional theory for a series of polyhalogenated dibenzo-1,4-dioxins, biphenyls, and other EDCs with methylselenolate, a simple model of the Dio active site selenocysteine. The strengths of the interactions depend upon the halogen (Br>Cl), the degree of substitution, and the position of the acceptor. In terms of donor-acceptor energies, interactions at the meta position are often the strongest, suggesting a link to the topology of THs, …


Examining The Oxidative Stress Effects In Rats Exposed To 2-Aminoanthracene In Utero And High Fat Diet Three Months After, Brianna A. Lanoix 2023 Georgia Southern University

Examining The Oxidative Stress Effects In Rats Exposed To 2-Aminoanthracene In Utero And High Fat Diet Three Months After, Brianna A. Lanoix

Honors College Theses

Polycyclic aromatic hydrocarbons are organic compounds that are created synthetically or found in partially burned oil, gasoline, and coal. 2-aminoanthracene (2AA) is a common example of a PAH and can affect lipid and carbohydrate metabolism and resulting in inflammatory problems and oxidative stress. The objective of the research project is to investigate oxidative stress in relation to diabetes in rats exposed to 2AA in utero and a high fat diet later in life. Pregnant dams were separated into treatment groups based on their dosages of 2AA; 0 mg/kg (control), 50 mg/kg (low), 100 mg/kg (high). During the gestation -postpartum period, …


Inhibition Of Rad18 By Arsenic, Lindsay B. Volk 2022 University of New Mexico

Inhibition Of Rad18 By Arsenic, Lindsay B. Volk

Biomedical Sciences ETDs

Arsenite exposure leads to the retention of UV-induced DNA damage, thus burdening translesion synthesis (TLS). Rad18 is an essential factor in initiating TLS through PCNA monoubiquitination and is implicated in homologous recombination. It contains two functionally and structurally distinct zinc fingers that are potential targets for arsenite binding. Results from this study reveal arsenite binding to both zinc fingers of Rad18 and a corresponding loss of domain function. Importantly, arsenite inhibited Rad18 RING-dependent PCNA monoubiquitination and polymerase eta recruitment to DNA damage. Further analysis demonstrated multiple effects of arsenite, including the reduction in the nuclear localization and UV-induced chromatin recruitment …


Hepatocyte-Hepatic Stellate Cell Axis In Potentiation Of Alcohol And Hiv-Induced Liver Injury, Moses O. New-Aaron 2022 University of Nebraska Medical Center

Hepatocyte-Hepatic Stellate Cell Axis In Potentiation Of Alcohol And Hiv-Induced Liver Injury, Moses O. New-Aaron

Theses & Dissertations

Human Immunodeficiency Virus (HIV) remains a global threat, with approximately 38.4 million active infections and 33 million HIV-related deaths since the first case. While many may be tempted to think of HIV as a relic of the past, emerging data suggests otherwise. By the end of 2021, approximately 1.5 million HIV incidences and 650 000 mortalities were reported globally. The etiologies of HIV-related mortality are numerous. Liver disease is one of the leading etiologies of HIV-related mortality, especially in recent times of antiretroviral therapy (ART)-induced longevity among people living with HIV (PLWH). While co-infections with hepatotropic viruses notoriously contribute to …


Effects Of Microcystin-Lr On Channel Catfish (Ictalurus Punctatus) Susceptibility To Microbial Pathogens (Aeromonas Hydrophila And Edwardsiella Piscicida), Alison Marchant 2022 Mississippi State University

Effects Of Microcystin-Lr On Channel Catfish (Ictalurus Punctatus) Susceptibility To Microbial Pathogens (Aeromonas Hydrophila And Edwardsiella Piscicida), Alison Marchant

Theses and Dissertations

Microcystin-LR is a hepatotoxin produced by cyanobacteria. Aeromonas hydrophila and Edwardsiella piscicida infections are leading causes of losses in market-sized channel catfish (Ictalurus punctatus). These older fish should have natural immunity in place and a predisposing factor is likely a prerequisite for these disease outbreaks. While microcystin-LR rarely causes mortality in warm-water aquaculture, we believe it may be a predisposing factor that leads to bacterial disease outbreaks during the summer months due to its ability to damage the liver. Our study investigated microcystin-LR’s effects on channel catfish susceptibility to these pathogens. We found that a sublethal dose of microcystin-LR induced …


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