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Characteristics of Clinical Trial Phases

Characteristics of Clinical Trial Phases

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Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world. Its mission includes ensuring that new medical treatments reach the public as quickly as possible while simultaneously ensuring that new treatments are both s...

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... Among them, drug discovery plays an important role as only 2.5% of potential drug candidates reach preclinical studies and only 5-10 of them proceed to human testing. [4][5][6] At this stage, large libraries of compounds (hundreds to thousands samples) are analyzed in high-throughput screening (HTS) assays with high purity and fully automatic robotic systems based on 384-and 1536-well plates in order to test metabolic function and pharmacokinetic and drug toxicity. [7][8][9] During this process, several potential drugs are identified and optimized to determine therapeutic efficacy and potential risks. ...
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Drug discovery is an expensive and lengthy process. Among the different phases, drug discovery and preclinical trials play an important role as only 5–10 of all drugs that begin preclinical tests proceed to clinical trials. Indeed, current high-throughput screening technologies are very expensive, as they are unable to dispense small liquid volumes in an accurate and quick way. Moreover, despite being simple and fast, drug screening assays are usually performed under static conditions, thus failing to recapitulate tissue-specific architecture and biomechanical cues present in vivo even in the case of 3D models. On the contrary, microfluidics might offer a more rapid and cost-effective alternative. Although considered incompatible with high-throughput systems for years, technological advancements have demonstrated how this gap is rapidly reducing. In this Review, we want to further outline the role of microfluidics in high-throughput drug screening applications by looking at the multiple strategies for cell seeding, compartmentalization, continuous flow, stimuli administration (e.g., drug gradients or shear stresses), and single-cell analyses.
... In the United States alone, one in four Americans were seen by a physician for one or more skin diseases in 2013 [2]. Skin diseases cost the United States healthcare system $75 billion in direct costs and $11 billion in indirect lost opportunity costs in 2013 [3]. The mean capitalized research and development investment required to bring a new drug to market is estimated at $1335.9 million and an average of 7 to 12 years from preclinical testing to drug approval [4,5]. ...
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Models of skin diseases, such as psoriasis and scleroderma, must accurately recapitulate the complex microenvironment of human skin to provide an efficacious platform for investigation of skin diseases. Skin disease research has been shifting from less complex and less relevant 2D (two-dimensional) models to significantly more relevant 3D (three-dimensional) models. Three-dimensional modeling systems are better able to recapitulate the complex cell–cell and cell–matrix interactions that occur in vivo within skin. Three-dimensional human skin equivalents (HSEs) have emerged as an advantageous tool for the study of skin disease in vitro. These 3D HSEs can be highly complex, containing both epidermal and dermal compartments with integrated adnexal structures. The addition of adnexal structures to 3D HSEs has allowed researchers to gain more insight into the complex pathology of various hereditary and acquired skin diseases. One method of constructing 3D HSEs, 3D bioprinting, has emerged as a versatile and useful tool for generating highly complex HSEs. The development of commercially available 3D bioprinters has allowed researchers to create highly reproducible 3D HSEs with precise integration of multiple adnexal structures. While the field of bioengineered models for study of skin disease has made tremendous progress in the last decade, there are still significant efforts necessary to create truly biomimetic skin disease models. In future studies utilizing 3D HSEs, emphasis must be placed on integrating all adnexal structures relevant to the skin disease under investigation. Thorough investigation of the intricate pathology of skin diseases and the development of effective treatments requires use of highly efficacious models of skin diseases.
... [26][27][28] The FDA helps by increasing the availability of generic drugs to make the treatment more affordable and increase access for more patients. [29][30][31][32] FDA, while working with federal agencies like the drug enforcement administration, customs and border protection, and consumer product safety commission of United States Department of Agriculture (USDA), regulates almost every facet of the prescription drug, including testing, manufacture, labelling, and advertising. The disease supervision and check are currently volunteered through gadgets like smart health wearables and online interactive platforms. ...
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With the transforming world, awareness of lifestyle-based variation is necessary. The availability of the locally available network and smart devices like wearable health devices (WHDs) based on artificial intelligence (AI) technology prompted us to learn about the disease, its causes, spreads, and precautions. Socioeconomic, environmental and behavioural factors, international travel and migration foster and increase the spread of communicable diseases. Vaccine-preventable, foodborne, zoonotic, healthcare-related and communicable diseases pose significant threats to human health and may sometimes threaten international health security. On the other hand, non-communicable diseases, also known as chronic diseases, are more prolonged. It could be the cause of different factors like genetic, environmental, behavioural or physiological disturbances. Smart wearables help to keep these diseases in check through different sensors installed in them. They can check for the difference in body function, but they can also help the needy consult the physician or practitioner. The data collected from these devices can also check the current health status when compiled with data collected practically. Organizations viz., World Health Organization (WHO), Food and Drug Administration (FDA) work collaboratively, leading global efforts to expand health coverage. WHO keeps the nation safe through connecting its people on the health and awareness interactive platforms, and FDA promotes public health through supervision and control, defending its role in human health and services.
... For example, the U.S.'s Food and Drug Agency (FDA) oversees the safety, effectiveness and manufacturing of contact lenses. Such a process has been criticised as expensive and costly [116], which may hinder the introduction of smart Numerous studies have also shown that contact lenses may lead to serious ocular health problems if certain cleaning guidelines are poorly observed [117], [118]. Nevertheless, despite these challenges, surveys have shown that contact lens wearers are often more satisfied than regular eye glass wearers [119]. ...
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Contact lenses have traditionally been used for vision correction applications. Recent advances in microelectronics and nanofabrication on flexible substrates have now enabled sensors, circuits and other essential components to be integrated on a small contact lens platform. This has opened up the possibility of using contact lenses for a range of human-machine interaction applications including vision assistance, eye tracking, displays and health care. In this article, we systematically review the range of smart contact lens materials, device architectures and components that facilitate this interaction for different applications. In fact, evidence from our systematic review demonstrates that these lenses can be used to display information, detect eye movements, restore vision and detect certain biomarkers in tear fluid. Consequently, whereas previous state-of the-art reviews in contact lenses focused exclusively on biosensing, our systematic review covers a wider range of smart contact lens applications in HMI. Moreover, we present a new method of classifying the literature on smart contact lenses according to their six constituent building blocks, which are the sensing, energy management, driver electronics, communications, substrate and the interfacing modules. Based on recent developments in each of these categories, we speculate the challenges and opportunities of smart contact lenses for human-machine interaction. Moreover, we propose a novel self-powered smart contact lens concept with integrated energy harvesters, sensors and communication modules to enable autonomous operation. Our review is therefore a critical evaluation of current data and is presented with the aim of guiding researchers to new research directions in smart contact lenses.
... As the phage preparation practices and buffer systems in which phage are stored have an impact on the application of PT and patient safety, these must first be reviewed prior to medical applications [5,19]. Unfortunately, lag times between the current need for an approved treatment and the earliest foreseeable approvals for alternative antimicrobials are worrying, with newly approved therapies taking approximately 12 years to arise from preclinical studies in the USA [29]. This, in conjunction with the estimates of deaths attributable to resistant infections,~700,000 per year already, have left us at an impasse [30]. ...
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The emergence of multi-drug resistant (MDR) bacteria is recognised today as one of the greatest challenges to public health. As traditional antimicrobials are becoming ineffective and research into new antibiotics is diminishing, a number of alternative treatments for MDR bacteria have been receiving greater attention. Bacteriophage therapies are being revisited and present a promising opportunity to reduce the burden of bacterial infection in this post-antibiotic era. This review focuses on the current evidence supporting bacteriophage therapy against prevalent or emerging multi-drug resistant bacterial pathogens in respiratory medicine and the challenges ahead in preclinical data generation. Starting with efforts to improve delivery of bacteriophages to the lung surface, the current developments in animal models for relevant efficacy data on respiratory infections are discussed before finishing with a summary of findings from the select human trials performed to date.
... Table 1. Bearing in mind what is known, regardless if at light of industrial procedures or academic researches [24][25], many years of high-level research supported by huge financial investments summarize what we know as being indispensable requirements to the development of a pharmacological drug [26][27]. In order to improve these two onerous factors, some time ago the use of computational tools has provided a cost reduction up to 50% for producing any kind of pharmaceutical drug [28][29][30]. ...
Article
In this current study, a selected group of physicochemical descriptors extracted from the formalism of the density functional theory were used for modeling a series of phthalimide congeners with tested hypolipidemic activity once. Based on unsupervised pattern recognition of HCA and PCA followed by the PLS regressions, the final content may be considered trustful for predicting the biological activity due to the results of r2cal = 0.937, r2CV = 0.591 and r2test = 0.85. Moreover, the molecular modeling was performed through the docking protocol for predicting the ligand pose on the HMG-CoA reductase. The protocols of the AutoDock Tools and AutoDock Vina were used for determining the interaction scores (ΔG) and inhibition constants (Ki). Among all congeners studied, the docking results pointed out a potential compound. By taking into account the widely known top selling drugs, and just as is well-known that atorvastatin is one of them due its capability to lower the cholesterol levels, the structure of this drug was subjected to a docking study in order to guide us to a better understanding of the results available here. DOI: http://dx.doi.org/10.17807/orbital.v13i3.1493
... Pharmaceuticals typically take 10 to 15 years to progress from initial molecule discovery to final drug development. Additionally, only 1 in 1000 potential drugs make it to the clinical trials, with 90% failing the human-testing phase [105]. Drug development is costly and requires substantial investment before pharmaceutical companies can make a profit [106]. ...
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The Actinomycetales order is one of great genetic and functional diversity, including diversity in the production of secondary metabolites which have uses in medical, environmental rehabilitation, and industrial applications. Secondary metabolites produced by actinomycete species are an abundant source of antibiotics, antitumor agents, anthelmintics, and antifungals. These actinomycete-derived medicines are in circulation as current treatments, but actinomycetes are also being explored as potential sources of new compounds to combat multidrug resistance in pathogenic bacteria. Actinomycetes as a potential to solve environmental concerns is another area of recent investigation, particularly their utility in the bioremediation of pesticides, toxic metals, radioactive wastes, and biofouling. Other applications include biofuels, detergents, and food preservatives/additives. Exploring other unique properties of actinomycetes will allow for a deeper understanding of this interesting taxonomic group. Combined with genetic engineering, microbial experimental evolution, and other enhancement techniques, it is reasonable to assume that the use of marine actinomycetes will continue to increase. Novel products will begin to be developed for diverse applied research purposes, including zymology and enology. This paper outlines the current knowledge of actinomycete usage in applied research, focusing on marine isolates and providing direction for future research.
... Virus-specific antiviral research remains a successful and essential strategy to combat viral infections [1]. However, a major obstacle to virus-specific drug development is the length of the process, which, on average, takes more than a decade between research and drug approval [2]. Indeed, virus-specific drug development needs first to address fundamental biology of the virus to find an appropriate target before moving to medicinal chemistry research, compounds screening, lead optimization, animal studies and eventual clinical trials. ...
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The emergence or re-emergence of viruses with epidemic and/or pandemic potential, such as Ebola, Zika, Middle East Respiratory Syndrome (MERS-CoV), Severe Acute Respiratory Syndrome Coronavirus 1 and 2 (SARS and SARS-CoV-2) viruses, or new strains of influenza represents significant human health threats due to the absence of available treatments. Vaccines represent a key answer to control these viruses. However, in the case of a public health emergency, vaccine development, safety, and partial efficacy concerns may hinder their prompt deployment. Thus, developing broad-spectrum antiviral molecules for a fast response is essential to face an outbreak crisis as well as for bioweapon countermeasures. So far, broad-spectrum antivirals include two main categories: the family of drugs targeting the host-cell machinery essential for virus infection and replication, and the family of drugs directly targeting viruses. Among the molecules directly targeting viruses, nucleoside analogues form an essential class of broad-spectrum antiviral drugs. In this review, we will discuss the interest for broad-spectrum antiviral strategies and their limitations, with an emphasis on virus-targeted, broad-spectrum, antiviral nucleoside analogues and their mechanisms of action.
... It usually takes more than 10 years on average for a drug to be marketed from the laboratory. [1,2] More years are necessary to monitor implants such as artificial organs, tissue scaffold, stent and artificial tissue to verify the material's safety in a long-term period. As a result, since the validation process is unavoidable, faster approaches in material research and development could help to accelerate the commercialization cycle. ...
... Before release into the market, the drug candidate needs to pass through preclinical in vitro and in vivo research on cell lines, microorganisms and animal model, followed by clinical trials on humans and final regulatory approval. This whole process takes more than seven years before hitting the market [8]. In this pandemic situation arising due to COVID-19, drug repurposing/drug repositioning (the investigation of existing drugs for new therapeutic purposes) has become an inevitable tool in order to develop safe and effective COVID-19 treatments faster. ...
Article
COVID-19 is a public health emergency of international concern. Although, considerable knowledge has been acquired with time about the viral mechanism of infection and mode of replication, yet no specific drugs or vaccines have been discovered against SARS-CoV-2, till date. There are few small molecule antiviral drugs like Remdesivir and Favipiravir which have shown promising results in different advanced stage of clinical trials. Chloroquinine, Hydroxychloroquine, and Lopinavir-Ritonavir combination, although initially was hypothesized to be effective against SARS-CoV-2, are now discontinued from the solidarity clinical trials. This review provides a brief description of their chemical syntheses along with their mode of action and clinical trial results available in Google and different peer reviewed journals till 24th October 2020.