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Drug Development - DOAJ

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Last Updated: 13 June 2022

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Endpoints in Heart Failure Drug Development

"The choice of endpoint in clinical trials has a huge practical and scientific effect. " The authors summarise the evolution and definition of cardiovascular endpoints used in clinical trials, discuss research design that allows the incorporation of mortality, morbidity, and functional endpoints, and, finally, assess the existing research and recommend actions for the establishment of cardiovascular endpoints that are safe, meaningful, and fulfill the needs of all key stakeholders, including patients, physicians, and sponsors.

Source link: https://doi.org/10.15420/cfr.2021.13


Applications for Induced Pluripotent Stem Cells in Disease Modelling and Drug Development for Heart Diseases

"Induced pluripotent stem cells are obtained from reprogrammed somatic cells by the addition of specific transcription factors. " A highly invasive procedure for cardiac tissue from patients with mutations for genetic analysis and functional analysis. Disease-specific hiPSCs, on the other hand, are isolated from the somatic cells of patients with particular genetic mutations responsible for disease phenotypes.

Source link: https://doi.org/10.15420/ecr.2019.03


Combining SJ733, an oral ATP4 inhibitor of Plasmodium falciparum, with the pharmacokinetic enhancer cobicistat: An innovative approach in antimalarial drug development

"Summary (Summary), a newly developed P. falciparum ATP4 inhibitor that has a positive safety profile and quick antiparasitic activity, but it is ineffective to provide a single-dose cure of malaria. In healthy volunteers, two multidose unboosted cohorts were followed by three single-dose boosted cohorts combining SJ733 with cobicistat as a pharmacokinetic booster were evaluated. The SJ733/cobicistat-boosted cohorts had a median rise in area under the curve and maximum concentration of 27% to parent drug 4u00b76 —u00d7 – respectively, with a median decrease in the ratio of the main CYP3A-produced metabolite SJ506 to the parent drug of 4u00b76 u00d7 to the standard u00d7 in comparison to unboosted cohorts and u00b76 u00b79 u00b76 a u00b79 u00b76 b76 00b76 u00b76 u00b A 3-day course of SJ733/cobicistat relative to a single 600-mg dose u00b5L, which Incorporating these results in a model of parasite dynamics revealed that parasite clearance from 106 to 1012 parasites/u00b5L. ".

Source link: https://doi.org/10.1016/j.ebiom.2022.104065


Utility of iPSC-Derived Cells for Disease Modeling, Drug Development, and Cell Therapy

"The emergence of induced pluripotent stem cells has enhanced our understanding of human disease, drug discovery, and regenerative medicine. " As a result, the use of iPSCs in drug research and validation has seen a dramatic increase in the last 15 years.

Source link: https://doi.org/10.3390/cells11111853


Alzheimer's disease drug development pipeline: 2021

"Abstract Introduction" The number of people with Alzheimer's disease around the world is on the rise. 126 agents have been licensed in 152 studies evaluating new drugs for AD: 28 drugs were tested in Phase 3 trials, 74 in Phase 2 and 24 in Phase 1, with 74 in Phase 2 and 24 in Phase 1. The overwhelming majority of drugs in trials were designed to improve AD's biological functions with the intention of disease reduction; 10. 3% are putative cognitive enhancement agents; and 7. 1% are prescription medications being developed to reduce neuropsychiatric symptoms; and 7. 1% are drug-based treatments being tested to reduce neuropsychiatric symptoms.

Source link: https://doi.org/10.1002/trc2.12179


Who funds Alzheimer's disease drug development?

"Abstract Introduction" Despite the rise in Alzheimer's disease cases in the United States, no new drugs have been approved in the United States since 2003. The costs associated with drug research are high, and they may act as a major deterrent to AD therapeutic trials. In this report, we examine the grant funding for AD clinical trials by analyzing the fiscal support for AD clinical trials. Methods We analyzed the funding sources of all AD trials over the past five years as reported on ClinicalTrials. gov. On the index date of this analysis, there were 136 trials ongoing for drugs in the U. S. AD therapeutic pipeline. The biopharmaceutical industry's Phase 2 DMT trials were split between the pharmaceutical industry and academic medical centers in Phase 3; disease-u2010modifying therapies in Phase 3 were almost entirely funded by the biopharmaceutical industry; diseaseu2010modifying therapies were nearly entirely funded by the biopharmaceutical industry;.

Source link: https://doi.org/10.1002/trc2.12185


Drug development for the treatment of onchocerciasis: Population pharmacokinetic and adverse events modeling of emodepside.

"Emodepside has demonstrated macrofilaricidal activity against a number of nematodes and is now under clinical investigation for onchocerciasis treatment. ii to measure the pharmacokinetic characteristics of emodepside, ii to link its use in unhealthy volunteers' experiences, and ii to suggest an improved dosing protocol for a proposed phase II study in onchocerciasis patients. Methodology / main findings From 142 participants in three phase I studies, including a single-dose and a multiple-dose dose-escalation study as well as a relative bioavailability analysis, plasma concentration-time profiles and adverse event information were obtained from 142 participants, including a single-dose and a relative bioavailability study. Both food and formulation had a major effect on absorption rate and relative bioavailability, which was included as an allometric function, and both food and formulation had a significant effect on absorption rate and relative bioavailability. An increase in peak plasma concentrations was associated with an increase in the likelihood of a drug-related TEAE of concern. ".

Source link: https://doi.org/10.1371/journal.pntd.0010219


Translational Research in Cancer Drug Development

"The emergence of humankind's effort to cure cancer by using those substances that are mainly part or extracts of plants and have been adapted as traditional herbal medicine. " Taxol is one example of a drug that can be manufactured through conventional drug manufacturing. Targeted therapy has been a very promising piece of drug development research, especially in cancer treatment. Although cancer has been characterized as a disease with intricate cell and histopathophysiology, the abundance of studies on proteins, such as receptors and hormones, as the hallmarks of cancer, have led to the investigation of carcinogenesis inhibition further based on molecular targeted therapy. The discovery of lapatinib as an anti-cancertin with a specific focus on HER-2 and EGFR is an interesting example of the drug being discovered based on molecular modeling, providing an excellent example of the drug being developed based on molecular modeling.

Source link: https://doi.org/10.14499/indonesianjcanchemoprev2iss2pp198-211


The role of basket trials in drug development for neurodegenerative disorders

"In the trial, we discovered 59 basket trials assessing the effects of treatment on more than a single NDD. " Parkinson's disease was the most common disease found in basket trials of symptomatic agents, and Alzheimer's disease was the most common condition in basket trials of disease-modifying therapies, with Alzheimer's disease being the most common disease. Pharmaceutical companies sponsored the majority of the basket trials testing DMTs in basket trials; in a similar manner, the biopharmaceutical industry sponsored the bulk of the trials investigating DMTs in basket trials. Conclusions Basket trials can help with drug delivery by reducing redundancy in trial setup, increasing recruiting, sharing placebo groups, and using biomarkers relevant to the treatment's mechanism of action across NDDs. The use of the basket trial method may be a way to improve the effectiveness of agent development programs to treat NDDs. ".

Source link: https://doi.org/10.1186/s13195-022-01015-6


A State-of-the-Art Roadmap for Biomarker-Driven Drug Development in the Era of Personalized Therapies

"Personalized medications have been delivered to the clinic by regulatory approvals of cancer genome sequencing panels and other related targeted therapies. " This report summarizes the current state of biomarker-driven drug discovery in the process, as well as examples illustrating the effectiveness and importance of including real-world data in the process. We also recommend that all parties interested in drug discovery be aware of and efficiently utilize real-world data, as well as re-vamp the way the industry approaches drug development in this period of personalized medicine.

Source link: https://doi.org/10.3390/jpm12050669

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions