scholarly journals Best practices in bioassay development to support registration of biopharmaceuticals

BioTechniques ◽  
2019 ◽  
Vol 67 (3) ◽  
pp. 126-137 ◽  
Author(s):  
John R White ◽  
Marla Abodeely ◽  
Sammina Ahmed ◽  
Gaël Debauve ◽  
Evan Johnson ◽  
...  
Keyword(s):  
Biological Activity ◽  
Best Practices ◽  
Mechanisms Of Action ◽  
Point Of View ◽  
Relative Potency ◽  
Quality Attribute ◽  
Critical Quality Attribute ◽  
Statistical Approaches ◽  
And Control

Biological activity is a critical quality attribute for biopharmaceuticals, which is accurately measured using an appropriate relative potency bioassay. Developing a bioassay is a complex, rigorous undertaking that needs to address several challenges including modelling all of the mechanisms of action associated with the biotherapeutic. Bioassay development is also an exciting and fast evolving field, not only from a scientific, medical and technological point of view, but also in terms of statistical approaches and regulatory expectations. This has led to an industry-wide discussion on the most appropriate ways to develop, validate and control the bioassays throughout the drug lifecycle.

DEVELOPMENT OF COMPUTERIZED MONITORING AND CONTROL SYSTEM OF THE MOBILE ROBOT’S POSITIONING ON LARGE FERROMAGNETIC SURFACES BASED ON INTELLIGENT TECHNIQUES. COMPLEX OF TASKS OF MONITORING AND AUTOMATIC CONTROL OF MOBILE

2019 ◽  
pp. 37-47
Author(s):  
Yao Yueqin ◽  
Oleksiy Kozlov ◽  
Oleksandr Gerasin ◽  
Galyna Kondratenko
Keyword(s):  
Automatic Control ◽  
Point Of View ◽  
Monitoring And Control ◽  
Large Area ◽  
Monitoring And Control System ◽  
Technical Parameters ◽  
Automatic Control Systems ◽  
Current State ◽  
Computerized Monitoring ◽  
And Control

Analysis and formalization of the monitoring and automatic control tasks of the MR for the movement and execution of various types of technological operations on inclined and vertical ferromagnetic surfaces are obtained. Generalized structure of mobile robotic complex is shown with main subsystems consideration. Critical analysis of the current state of the problem of development of universal structures of mobile robots (MRs) for the various types of technological operations execution and elaborations of computerized systems for monitoring and control of MR movement is done. In particular, wheeled, walked and crawler type MRs with pneumatic, vacuum-propeller, magnetic and magnetically operated clamping devices to grip with vertical and ceiling surfaces are reviewed. The constructive features of the crawler MR with magnetic clamping devices capable of moving along sloping ferromagnetic surfaces are considered. The basic technical parameters of the MR are shown for the further synthesis of computerized monitoring and automatic control systems. Formalization of the tasks of monitoring and control of the MR positioning at the processing of large area ferromagnetic surfaces is considered from the point of view of control theory.

ABOUT UNIFORMITY OF THE PHENOMENOLOGY AND THE MATHEMATICAL DESCRIPTION OF SO-CALLED « JOINED» ACTION OF HAZARDS AND COMBINED TOXICITY (ON THE EXAMPLE OF A COMBIBATION OF THE FLUORIDE AND THE STATIC MAGNETIC FIELD)

2016 ◽  
pp. 13-20
Author(s):  
B. A. Katsnelson ◽  
M. P. Sutunkova ◽  
N. A. Tsepilov ◽  
V. G. Panov ◽  
A. N. Varaksin ◽  
...  
Keyword(s):  
Magnetic Field ◽  
Static Magnetic Field ◽  
Point Of View ◽  
Whole Body ◽  
Surface Model ◽  
Combined Toxicity ◽  
Fluoride Solution ◽  
Adverse Action ◽  
Biochemical Indices ◽  
And Control

Sodium fluoride solution was injected i.p. to three groups of rats at a dose equivalent to 0.1 LD50 three times a week up to 18 injections. Two out of these groups and two out of three groups were sham-injected with normal saline and were exposed to the whole body impact of a 25 mT static magnetic field (SMF) for 2 or 4 hr a day, 5 times a week. Following the exposure, various functional and biochemical indices were evaluated along with histological examination and morphometric measurements of the femur in the differently exposed and control rats. The mathematical analysis of the combined effects of the SMF and fluoride based on the a response surface model demonstrated that, in full correspondence with what we had previously found for the combined toxicity of different chemicals, the combined adverse action of a chemical plus a physical agent was characterized by a tipological diversity depending not only on particular effects these types were assessed for but on the dose and effect levels as well. From this point of view, the indices for which at least one statistically significant effect was observed could be classified as identifying (I) mainly single-factor action; (II) additive unidirectional action; (III) synergism (superadditive unidirectional action); (IV) antagonism, including both subadditive unidirectional action and all variants of contradirectional action.

scholarly journals Tetrandrine alleviates silicosis by inhibiting canonical and non-canonical NLRP3 inflammasome activation in lung macrophages

2021 ◽  
Author(s):  
Mei-yue Song ◽  
Jia-xin Wang ◽  
You-liang Sun ◽  
Zhi-fa Han ◽  
Yi-tian Zhou ◽  
...  
Keyword(s):  
Nlrp3 Inflammasome ◽  
Therapeutic Strategy ◽  
Molecular Targets ◽  
Mechanisms Of Action ◽  
Inflammasome Activation ◽  
Lung Macrophages ◽  
Nlrp3 Inflammasome Activation ◽  
Function Test ◽  
And Control ◽  
Therapeutic Administration

AbstractSilicosis caused by inhalation of silica particles leads to more than ten thousand new occupational exposure-related deaths yearly. Exacerbating this issue, there are currently few drugs reported to effectively treat silicosis. Tetrandrine is the only drug approved for silicosis treatment in China, and despite more than decades of use, its efficacy and mechanisms of action remain largely unknown. Here, in this study, we established silicosis mouse models to investigate the effectiveness of tetrandrine of early and late therapeutic administration. To this end, we used multiple cardiopulmonary function test, as well as markers for inflammation and fibrosis. Moreover, using single cell RNA sequencing and transcriptomics of lung tissue and quantitative microarray analysis of serum from silicosis and control mice, our results provide a novel description of the target pathways for tetrandrine. Specifically, we found that tetrandrine attenuated silicosis by inhibiting both the canonical and non-canonical NLRP3 inflammasome pathways in lung macrophages. Taken together, our work showed that tetrandrine yielded promising results against silicosis-associated inflammation and fibrosis and further lied the groundwork for understanding its molecular targets. Our results also facilitated the wider adoption and development of tetrandirne, potentially accelerating a globally accepted therapeutic strategy for silicosis.

scholarly journals The Hallmarks of Flavonoids in Cancer

Molecules ◽  
2021 ◽  
Vol 26 (7) ◽  
pp. 2029
Author(s):  
Luis Gustavo Saboia Ponte ◽  
Isadora Carolina Betim Pavan ◽  
Mariana Camargo Silva Mancini ◽  
Luiz Guilherme Salvino da Silva ◽  
Ana Paula Morelli ◽  
...  
Keyword(s):  
Cell Cycle ◽  
Cell Proliferation ◽  
Biological Activity ◽  
Neurological Disorders ◽  
Mechanisms Of Action ◽  
Molecular Signaling ◽  
Hallmarks Of Cancer ◽  
Redox Metabolism ◽  
Important Group ◽  
Cellular Context

Flavonoids represent an important group of bioactive compounds derived from plant-based foods and beverages with known biological activity in cells. From the modulation of inflammation to the inhibition of cell proliferation, flavonoids have been described as important therapeutic adjuvants against several diseases, including diabetes, arteriosclerosis, neurological disorders, and cancer. Cancer is a complex and multifactor disease that has been studied for years however, its prevention is still one of the best known and efficient factors impacting the epidemiology of the disease. In the molecular and cellular context, some of the mechanisms underlying the oncogenesis and the progression of the disease are understood, known as the hallmarks of cancer. In this text, we review important molecular signaling pathways, including inflammation, immunity, redox metabolism, cell growth, autophagy, apoptosis, and cell cycle, and analyze the known mechanisms of action of flavonoids in cancer. The current literature provides enough evidence supporting that flavonoids may be important adjuvants in cancer therapy, highlighting the importance of healthy and balanced diets to prevent the onset and progression of the disease.

scholarly journals Differences in PARP Inhibitors for the Treatment of Ovarian Cancer: Mechanisms of Action, Pharmacology, Safety, and Efficacy

2021 ◽  
Vol 22 (8) ◽  
pp. 4203
Author(s):  
Giorgio Valabrega ◽  
Giulia Scotto ◽  
Valentina Tuninetti ◽  
Arianna Pani ◽  
Francesco Scaglione
Keyword(s):  
Ovarian Cancer ◽  
Signal Transduction ◽  
Dna Damage ◽  
Chemical Structure ◽  
Parp Inhibitors ◽  
Mechanisms Of Action ◽  
Point Of View ◽  
Safety And Efficacy ◽  
Damage Repair ◽  
Pharmacokinetic Properties

Poly(ADP-ribose) polymerases (PARP) are proteins responsible for DNA damage detection and signal transduction. PARP inhibitors (PARPi) are able to interact with the binding site for PARP cofactor (NAD+) and trapping PARP on the DNA. In this way, they inhibit single-strand DNA damage repair. These drugs have been approved in recent years for the treatment of ovarian cancer. Although they share some similarities, from the point of view of the chemical structure and pharmacodynamic, pharmacokinetic properties, these drugs also have some substantial differences. These differences may underlie the different safety profiles and activity of PARPi.

scholarly journals Infection Prevention Considerations for a Multi-Mission Convention Center Field Hospital in Baltimore, Maryland during the COVID-19 Pandemic

2021 ◽  
pp. 1-21
Author(s):  
Jennifer A. Jones ◽  
Zishan K. Siddiqui ◽  
Charles Callahan ◽  
Surbhi Leekha ◽  
Sharon Smyth ◽  
...  
Keyword(s):  
Best Practices ◽  
Infection Prevention ◽  
Diagnostic Testing ◽  
The United States ◽  
Infection Prevention And Control ◽  
Field Hospital ◽  
First Case ◽  
Convention Center ◽  
Set Up ◽  
And Control

Abstract The state of Maryland identified its first case of COVID-19 on March 5, 2020. The Baltimore Convention Center (BCCFH) quickly became a selected location to set up a 250-bed inpatient Field Hospital and Alternate Care Site. In contrast to other field hospitals throughout the United States, the BCCFH remained open throughout the pandemic and took on additional COVID-19 missions, including community SARS-CoV-2 diagnostic testing, monoclonal antibody infusions for COVID-19 outpatients, and community COVID-19 vaccinations. At the time of publication, the BCCFH had cared for 1,478 COVID-19 inpatients, performed 108,155 COVID-19 tests, infused 2,166 COVID-19 patients, and administered 115,169 doses of COVID-19 vaccine. To prevent the spread of pathogens during operations, infection prevention and control guidelines were essential to ensure the safety of staff and patients. Through multi-agency collaboration, utilization of infection prevention best practices, and answering what we describe as “PPE-ESP”, an operational framework was established to reduce infection risks for those providing or receiving care at the BCCFH during the COVID-19 pandemic.

Cyclopean Vision, Size Estimation, and Presence in Orthostereoscopic Images

2001 ◽  
Vol 10 (3) ◽  
pp. 312-330 ◽  
Author(s):  
Bernard Harper ◽  
Richard Latto
Keyword(s):  
Visual System ◽  
Three Dimensional ◽  
Point Of View ◽  
Psychophysical Experiment ◽  
Size Estimation ◽  
Human Form ◽  
Image Capture ◽  
Series Of Experiments ◽  
Abstract Shapes ◽  
And Control

Stereo scene capture and generation is an important facet of presence research in that stereoscopic images have been linked to naturalness as a component of reported presence. Three-dimensional images can be captured and presented in many ways, but it is rare that the most simple and “natural” method is used: full orthostereoscopic image capture and projection. This technique mimics as closely as possible the geometry of the human visual system and uses convergent axis stereography with the cameras separated by the human interocular distance. It simulates human viewing angles, magnification, and convergences so that the point of zero disparity in the captured scene is reproduced without disparity in the display. In a series of experiments, we have used this technique to investigate body image distortion in photographic images. Three psychophysical experiments compared size, weight, or shape estimations (perceived waist-hip ratio) in 2-D and 3-D images for the human form and real or virtual abstract shapes. In all cases, there was a relative slimming effect of binocular disparity. A well-known photographic distortion is the perspective flattening effect of telephoto lenses. A fourth psychophysical experiment using photographic portraits taken at different distances found a fattening effect with telephoto lenses and a slimming effect with wide-angle lenses. We conclude that, where possible, photographic inputs to the visual system should allow it to generate the cyclopean point of view by which we normally see the world. This is best achieved by viewing images made with full orthostereoscopic capture and display geometry. The technique can result in more-accurate estimations of object shape or size and control of ocular suppression. These are assets that have particular utility in the generation of realistic virtual environments.

scholarly journals PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections

2018 ◽  
Vol 72 (3) ◽  
pp. 332-337
Author(s):  
Deb Autor ◽  
Zena Kaufman ◽  
Ron Tetzlaff ◽  
Maryann Gribbin ◽  
Madlene Dole ◽  
...  
Keyword(s):  
Best Practices ◽  
Data Management ◽  
Data Integrity ◽  
And Control

scholarly journals Activity and Mechanism of Action of Antifungal Peptides from Microorganisms: A Review

Molecules ◽  
2021 ◽  
Vol 26 (11) ◽  
pp. 3438
Author(s):  
Tianxi Li ◽  
Lulu Li ◽  
Fangyuan Du ◽  
Lei Sun ◽  
Jichao Shi ◽  
...  
Keyword(s):  
Mechanisms Of Action ◽  
Antifungal Drugs ◽  
Drug Resistant ◽  
Important Research ◽  
Factors Affecting ◽  
Natural Substances ◽  
Therapeutic Drugs ◽  
Antifungal Peptides ◽  
Control Work ◽  
And Control

Harmful fungi in nature not only cause diseases in plants, but also fungal infection and poisoning when people and animals eat food derived from crops contaminated with them. Unfortunately, such fungi are becoming increasingly more resistant to traditional synthetic antifungal drugs, which can make prevention and control work increasingly more difficult to achieve. This means they are potentially very harmful to human health and lifestyle. Antifungal peptides are natural substances produced by organisms to defend themselves against harmful fungi. As a result, they have become an important research object to help deal with harmful fungi and overcome their drug resistance. Moreover, they are expected to be developed into new therapeutic drugs against drug-resistant fungi in clinical application. This review focuses on antifungal peptides that have been isolated from bacteria, fungi, and other microorganisms to date. Their antifungal activity and factors affecting it are outlined in terms of their antibacterial spectra and effects. The toxic effects of the antifungal peptides and their common solutions are mentioned. The mechanisms of action of the antifungal peptides are described according to their action pathways. The work provides a useful reference for further clinical research and the development of safe antifungal drugs that have high efficiencies and broad application spectra.

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