scholarly journals Subsequent Entry Biologics in Canada: Current State of the Science

2015 ◽  
Vol 18 (2) ◽  
pp. 177 ◽  
Author(s):  
Laszlo Endrenyi ◽  
Fakhreddin Jamali ◽  
Raimar Loebenberg
Keyword(s):  
Product Quality ◽  
Clinical Data ◽  
Pharmaceutical Sciences ◽  
Canadian Society ◽  
Regulatory Requirements ◽  
Safety And Efficacy ◽  
Current State ◽  
Wide Range ◽  
State Of The Science ◽  
Health Canada

The Canadian Society for Pharmaceutical Sciences organized a workshop on the current state of sciences of subsequent entry biologics (SEBs, biosimilars) on December 10th 2014 in the Health Canada location in Ottawa, ON. The day-long workshop provided an opportunity to discuss recent regulatory developments and a wide range of scientific issues related to SEBs. Following a discussion on the differences between the Canadian guidance and those of other countries,  a series of presentations were made that focused on the regulatory requirements with regard to the product quality, methodology, non-clinical and clinical data. In addition, issues of extrapolation from one indication to another, interchangeability and reimbursement  were articulated. It was also highlighted that both the patients and caregivers need to be better informed regarding the safety and efficacy of articulated SEBs.

scholarly journals ALS drug development guidances and trial guidelines

Neurology ◽  
2019 ◽  
Vol 93 (2) ◽  
pp. 66-71 ◽  
Author(s):  
Jinsy A. Andrews ◽  
Lucie I. Bruijn ◽  
Jeremy M. Shefner
Keyword(s):  
Drug Development ◽  
External Input ◽  
Draft Guidance ◽  
Current State ◽  
Community Stakeholders ◽  
Predictive Algorithms ◽  
Wide Range ◽  
The Us ◽  
New Treatments ◽  
State Of The Science

The US Food and Drug Administration (FDA) developed a draft guidance for drug development in amyotrophic lateral sclerosis (ALS) that was issued in February 2018. The FDA draft guidance considered the recommendations developed by the ALS community that incorporated the views of a large group of clinical investigators, industry representatives, advocacy groups, patients, and caregivers. This external input from the ALS community reviewed the current state of clinical research in ALS, made suggestions over a wide range of drug development topics, and served as an educational tool to provide the agency with additional inputs about ALS, the state of the science, and the community's views on key topics. In parallel to this effort, there was an independent effort to revise and update the ALS Clinical Trial Guidelines. We discuss the areas of agreement of these 3 documents and the areas that provide opportunities to improve the efficiency of drug development in ALS. It is likely that further research into biomarkers, efficacy endpoints, and predictive algorithms will provide greater alignment among community stakeholders and increase clarity on drug development efforts going forward. Continued patient engagement and inclusion of patient experience data in every aspect of the drug development process will further facilitate the approval of new treatments.

scholarly journals Biowaiver for Immediate and Modified Release Dosage forms Scientific summary of the CSPS workshop

2020 ◽  
Vol 23 ◽  
Author(s):  
Raimar Loebenberg
Keyword(s):  
Dosage Forms ◽  
Pharmaceutical Sciences ◽  
Modified Release ◽  
Canadian Society ◽  
Health Canada

A joint Canadian Society for Pharmaceutical Sciences and Health Canada workshop entitled “Biowaiver for Immediate and Modified Release Dosage forms” was held in Ottawa, November 19th 2015. A summary of all presentations is included.

Integrating big data analytical techniques in pharmacy education

2020 ◽  
Author(s):  
Kerui Peng ◽  
Lana S. Martin ◽  
Houda Alachkar ◽  
Annie Wong-Beringer ◽  
SERGHEI MANGUL
Keyword(s):  
Big Data ◽  
Data Analysis ◽  
Clinical Data ◽  
Clinical Pharmacy ◽  
Analytical Techniques ◽  
Big Data Analysis ◽  
Pharmacy Education ◽  
Pharmaceutical Sciences ◽  
Training Models ◽  
Current State

Big data is revolutionizing pharmaceutical and clinical pharmacy research. With the availability of big data, including omics and clinical data, pharmaceutical scientists and pharmacists have the potential to advance basic and clinical science discovery if they acquire essential big data analytical techniques. The gap between the current state of pharmaceutical sciences and pharmacy education and core big data analytical techniques in research underscores the need to establish innovative training models for big data analysis and visualization.

Young Scholars Conference “Slavic World: Commonality and Diversity”. 21–22 May 2019. Session “Linguistics”

2019 ◽  
Vol 14 (1-2) ◽  
pp. 295-297
Author(s):  
Sergej A. Borisov
Keyword(s):  
Czech Republic ◽  
Middle Ages ◽  
The Czech Republic ◽  
International Context ◽  
Slavic Languages ◽  
Russian Academy Of Sciences ◽  
Current State ◽  
Wide Range ◽  
History Of ◽  
Academy Of Sciences

For more than twenty years, the Institute of Slavic Studies of the Russian Academy of Sciences celebrates the Day of Slavic Writing and Culture with a traditional scholarly conference.”. Since 2014, it has been held in the young scholars’ format. In 2019, participants from Moscow, St. Petersburg, Kazan, Togliatti, Tyumen, Yekaterinburg, and Rostov-on-Don, as well as Slovakia, the Czech Republic, Hungary, and Romania continued this tradition. A wide range of problems related to the history of the Slavic peoples from the Middle Ages to the present time in the national, regional and international context were discussed again. Participants talked about the typology of Slavic languages and dialects, linguo-geography, socio- and ethnolinguistics, analyzed formation, development, current state, and prospects of Slavic literatures, etc.

scholarly journals A Phase II Safety and Efficacy Study on Prognosis of Moderate Pneumonia in COVID-19 patients with Regular Intravenous Immunoglobulin Therapy

2021 ◽  
Author(s):  
Raman R S ◽  
Vijaykumar Bhagwan Barge ◽  
Anil Kumar Darivenula ◽  
Himanshu Dandu ◽  
Rakesh R Kartha ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Randomized Study ◽  
Standard Of Care ◽  
Immunoglobulin Therapy ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Intravenous Immunoglobulin Therapy ◽  
Safety And Efficacy ◽  
Therapeutic Benefits ◽  
Wide Range

Abstract Background Currently, there is no specific drug for the treatment of COVID-19. Therapeutic benefits of intravenous immunoglobin (IVIG) have been demonstrated in wide range of diseases. The present study is conducted to evaluate the safety and efficacy of IVIG in the treatment of COVID-19 patients with moderate pneumonia. Methods An open-label, multicenter, comparative, randomized study was conducted on COVID-19 patients with moderate pneumonia. 100 eligible patients were randomized in 1:1 ratio either to receive IVIG + standard of care (SOC) or SOC. Results Duration of hospital stay was significantly shorter in IVIG group to that of SOC alone (7.7 Vs. 17.5 days). Duration for normalization of body temperature, oxygen saturation and mechanical ventilation were significantly shorter in IVIG compared to SOC. Percentages of patients on mechanical ventilation in two groups were not significantly different (24% Vs. 38%). Median time to RT-PCR negativity was significantly shorter with IVIG than SOC (7 Vs.18 days). There were only mild to moderate adverse events in both groups except for one patient (2%), who died in SOC. Conclusions IVIG was safe and efficacious as an adjuvant with other antiviral drugs in the treatment of COVID-19. The trial was registered under Clinical Trial Registry, India (CTRI/2020/06/026222).

scholarly journals Citizen views on genome editing: effects of species and purpose

2021 ◽  
Author(s):  
Gesa Busch ◽  
Erin Ryan ◽  
Marina A. G. von Keyserlingk ◽  
Daniel M. Weary
Keyword(s):  
Disease Resistance ◽  
Product Quality ◽  
Genome Editing ◽  
Total Sample ◽  
Moral Foundations ◽  
Perceived Risks ◽  
Public Response ◽  
The Public ◽  
Wide Range ◽  
The Us

AbstractPublic opinion can affect the adoption of genome editing technologies. In food production, genome editing can be applied to a wide range of applications, in different species and with different purposes. This study analyzed how the public responds to five different applications of genome editing, varying the species involved and the proposed purpose of the modification. Three of the applications described the introduction of disease resistance within different species (human, plant, animal), and two targeted product quality and quantity in cattle. Online surveys in Canada, the US, Austria, Germany and Italy were carried out with a total sample size of 3698 participants. Using a between-subject design, participants were confronted with one of the five applications and asked to decide whether they considered it right or wrong. Perceived risks, benefits, and the perception of the technology as tampering with nature were surveyed and were complemented with socio-demographics and a measure of the participants’ moral foundations. In all countries, participants evaluated the application of disease resistance in humans as most right to do, followed by disease resistance in plants, and then in animals, and considered changes in product quality and quantity in cattle as least right to do. However, US and Italian participants were generally more positive toward all scenarios, and German and Austrian participants more negative. Cluster analyses identified four groups of participants: ‘strong supporters’ who saw only benefits and little risks, ‘slight supporters’ who perceived risks and valued benefits, ‘neutrals’ who showed no pronounced opinion, and ‘opponents’ who perceived higher risks and lower benefits. This research contributes to understanding public response to applications of genome editing, revealing differences that can help guide decisions related to adoption of these technologies.

scholarly journals β-Lactoglobulin Adsorption Layers at the Water/Air Surface: 5. Adsorption Isotherm and Equation of State Revisited, Impact of pH

2021 ◽  
Vol 5 (1) ◽  
pp. 14
Author(s):  
Georgi G. Gochev ◽  
Volodymyr I. Kovalchuk ◽  
Eugene V. Aksenenko ◽  
Valentin B. Fainerman ◽  
Reinhard Miller
Keyword(s):  
Theoretical Description ◽  
Fluid Interfaces ◽  
Interfacial Behavior ◽  
Current State ◽  
Air Interface ◽  
Direct Measurements ◽  
Wide Range ◽  
Dilational Viscoelasticity ◽  
Parameter Values ◽  
Β Lactoglobulin

The theoretical description of the adsorption of proteins at liquid/fluid interfaces suffers from the inapplicability of classical formalisms, which soundly calls for the development of more complicated adsorption models. A Frumkin-type thermodynamic 2-d solution model that accounts for nonidealities of interface enthalpy and entropy was proposed about two decades ago and has been continuously developed in the course of comparisons with experimental data. In a previous paper we investigated the adsorption of the globular protein β-lactoglobulin at the water/air interface and used such a model to analyze the experimental isotherms of the surface pressure, Π(c), and the frequency-, f-, dependent surface dilational viscoelasticity modulus, E(c)f, in a wide range of protein concentrations, c, and at pH 7. However, the best fit between theory and experiment proposed in that paper appeared incompatible with new data on the surface excess, Γ, obtained from direct measurements with neutron reflectometry. Therefore, in this work, the same model is simultaneously applied to a larger set of experimental dependences, e.g., Π(c), Γ(c), E(Π)f, etc., with E-values measured strictly in the linear viscoelasticity regime. Despite this ambitious complication, a best global fit was elaborated using a single set of parameter values, which well describes all experimental dependencies, thus corroborating the validity of the chosen thermodynamic model. Furthermore, we applied the model in the same manner to experimental results obtained at pH 3 and pH 5 in order to explain the well-pronounced effect of pH on the interfacial behavior of β-lactoglobulin. The results revealed that the propensity of β-lactoglobulin globules to unfold upon adsorption and stretch at the interface decreases in the order pH 3 > pH 7 > pH 5, i.e., with decreasing protein net charge. Finally, we discuss advantages and limitations in the current state of the model.

scholarly journals Status of Phenological Research Using Sentinel-2 Data: A Review

2020 ◽  
Vol 12 (17) ◽  
pp. 2760
Author(s):  
Gourav Misra ◽  
Fiona Cawkwell ◽  
Astrid Wingler
Keyword(s):  
Vegetation Index ◽  
Temporal Frequency ◽  
Short Wave ◽  
Current State ◽  
Red Edge ◽  
Natural Grasslands ◽  
Wide Range ◽  
Normalised Difference Vegetation Index ◽  
Satellite Sensors ◽  
Sentinel 2

Remote sensing of plant phenology as an indicator of climate change and for mapping land cover has received significant scientific interest in the past two decades. The advancing of spring events, the lengthening of the growing season, the shifting of tree lines, the decreasing sensitivity to warming and the uniformity of spring across elevations are a few of the important indicators of trends in phenology. The Sentinel-2 satellite sensors launched in June 2015 (A) and March 2017 (B), with their high temporal frequency and spatial resolution for improved land mapping missions, have contributed significantly to knowledge on vegetation over the last three years. However, despite the additional red-edge and short wave infra-red (SWIR) bands available on the Sentinel-2 multispectral instruments, with improved vegetation species detection capabilities, there has been very little research on their efficacy to track vegetation cover and its phenology. For example, out of approximately every four papers that analyse normalised difference vegetation index (NDVI) or enhanced vegetation index (EVI) derived from Sentinel-2 imagery, only one mentions either SWIR or the red-edge bands. Despite the short duration that the Sentinel-2 platforms have been operational, they have proved their potential in a wide range of phenological studies of crops, forests, natural grasslands, and other vegetated areas, and in particular through fusion of the data with those from other sensors, e.g., Sentinel-1, Landsat and MODIS. This review paper discusses the current state of vegetation phenology studies based on the first five years of Sentinel-2, their advantages, limitations, and the scope for future developments.

scholarly journals Antioxidant Activity in Bee Products: A Review

Antioxidants ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 71
Author(s):  
Marianna Martinello ◽  
Franco Mutinelli
Keyword(s):  
Analytical Methods ◽  
Nutritional Value ◽  
Royal Jelly ◽  
Antioxidant Activities ◽  
Natural Antioxidants ◽  
Bioactive Substances ◽  
Current State ◽  
Wide Range ◽  
Ancient Times ◽  
Antioxidant Characteristics

Bee products have been used since ancient times both for their nutritional value and for a broad spectrum of therapeutic purposes. They are deemed to be a potential source of natural antioxidants that can counteract the effects of oxidative stress underlying the pathogenesis of many diseases. In view of the growing interest in using bioactive substances from natural sources to promote health and reduce the risk of developing certain illnesses, this review aims to update the current state of knowledge on the antioxidant capacity of bee products such as honey, pollen, propolis, beeswax, royal jelly and bee venom, and on the analytical methods used. The complex, variable composition of these products and the multitude of analytical methods used to study their antioxidant activities are responsible for the wide range of results reported by a plethora of available studies. This suggests the need to establish standardized methods to more efficiently evaluate the intrinsic antioxidant characteristics of these products and make the data obtained more comparable.

Future trends in diagnosis using laboratory-on-a-chip technologies

Parasitology ◽  
1999 ◽  
Vol 117 (7) ◽  
pp. 191-203 ◽  
Author(s):  
M. S. TALARY ◽  
J. P. H. BURT ◽  
R. PETHIG
Keyword(s):  
Gene Expression ◽  
Lower Cost ◽  
Building Blocks ◽  
Cancer Diagnostics ◽  
Future Trends ◽  
Biotechnological Applications ◽  
Environmental Testing ◽  
Current State ◽  
Microelectronic Fabrication ◽  
Wide Range

There has been an enormous growth in the development of biotechnological applications, where advances in the techniques of microelectronic fabrication and the technologies of miniaturization and integration in semiconductor industries are being applied to the production of Laboratory-on-a-Chip devices. The aim of this development is to create devices that will perform the same processes that are currently carried out in the laboratory in reduced timescales, at a lower cost, requiring less reagents, and with a greater resolution of detection and specificity. The expectations of this Laboratory-on-a-Chip revolution is that this technology will facilitate rapid advances in gene discovery, genetic mapping and gene expression with broader applications ranging from infectious diseases and cancer diagnostics to food quality and environmental testing. A review of the current state of development in this field reveals the scale of the ongoing revolution and serves to highlight the advances that can be perceived in the development of Laboratory-on-a-Chip technologies. Since miniaturization can be applied to such a wide range of laboratory processes, some of the sub-units that can be used as building blocks in these devices are described, with a brief description of some of the fabrication processes that can be used to create them.

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