Biosimilars: Novel Emerging Field of Biomedicine

2021 ◽  
Vol 14 (5) ◽  
pp. 5588-5593
Author(s):  
Anshi Mehra ◽  
Hemanreet Kaur ◽  
Anoor Fatima ◽  
Aman Noor ◽  
Khushi Gupta ◽  
...  
Keyword(s):  
Price Competition ◽  
Production Efficiency ◽  
Drug Product ◽  
New Product ◽  
Marketing Approval ◽  
Original Research ◽  
Original Product ◽  
Reduced Costs ◽  
Us Fda

A biosimilar is the new emerging drug product of the sector of Biologics that comes under speedily evolving area of pharmaceutical industry. It is the generic substitute for original research-based drugs. Since the Biologics are produced by a variety of products more commonly including cells extracted from humans, animals, microorganisms which varies phenotypically therefore they are “similar but not same” to the original product. Being a new product, it produces several challenges in the market including its regulation guidelines, production efficiency, quality management, and safety factors etc. The quality of these products along with its effectiveness and reduced costs are making them more and more popular. Different research is still being going on for enhancing the efficacy of biosimilars due to its more and more usage in the market. Several countries have developed their separate norms for the production and clinical usage of these biosimilars constituting Canada, Japan, Korea, and United States of America etc. The more biologics grab the attention of the eminent scientists for better innovations, the less marketing approval it gets. To enhance such a situation U S Congress passed the Biologics Price Competition and Innovation act 2009 and US FDA allowed “abbreviated pathway” for their approval and India being the most suited manufacturing area has also prepared certain guidelines stated as “Draft Guidelines on Similar Biologics” which were announced in June 2012, by Department of Biotechnology at Boston bio. The regulatory environment for biosimilars continues to evolve, both in recognition of advances in technology/ analytical methods and the availability of new targets for biosimilar development. With the advent of such efforts biosimilars are trying to surround the market. The demanding sector of biosimilars reveals the challenging gateway towards the nanomedicines also which shows that with the advancing biotechnology after these biosimilars, we are heading towards other newly biologically derived products.           

scholarly journals The Practice of Service Quality: Hotel Case

2016 ◽  
Vol 6 (1) ◽  
pp. 30
Author(s):  
Gülten YURTSEVEN ◽  
Zehra MULUK
Keyword(s):  
Service Quality ◽  
Price Competition ◽  
Consumer Satisfaction ◽  
Service Sector ◽  
Evaluation Process ◽  
Total Quality ◽  
Perceived Service Quality ◽  
Demand Fluctuations ◽  
Reduced Costs

The service sector differs from the goods sector with its own characteristics. The service quality has an abstract structure since the services include abstract qualities. Therefore "perceived service quality" term is used instead of the quality of service. Perceived service quality is the perception difference as a result of evaluation process in which the expectations of consumer about performance of service before use and the real service experience after use. Perceived service quality should meet or exceed the expectations of consumer to be considered as satisfactory. The satisfaction from service increases as the service quality increases and thus the demand of consumer to reuse the service increases. That is to say, ensuring the consumer satisfaction in the hotel administration has an important role for consumers to prefer the same enterprise and the enterprise ensuring the consumer satisfaction has a great advantage in competition or keeps itself out of the price competition by increasing its service quality in this sector including significant demand fluctuations. Thus, enterprises ensure the increased efficiency, reduced costs and continuous employment of personnel in the enterprise. Key Words: Total Quality Management (TKY), Hotel administrations, Quality

scholarly journals Dynamics of the level of BIM application in Russia in 2017-2019

2020 ◽  
Vol 220 ◽  
pp. 01025
Author(s):  
Tatyana Kisel
Keyword(s):  
Cost Efficiency ◽  
Quantitative Research ◽  
Production Efficiency ◽  
Building Information Modeling ◽  
Labour Productivity ◽  
New Product ◽  
Information Modeling ◽  
Huge Number ◽  
Building Information

Nowadays digitalization became one of the most significant trends of the economy and society development. Digitalization of the production and non-productive processes in various sectors of the economy allows to increase the labour productivity considerably, to provide new product quality as well as to achieve high rates of cost efficiency. Digitalization in construction is provided due to the transition to building information modeling (BIM). Implementation of BIM goes unevenly in the different countries. This paper represents the results of the research of dynamics of the level of BIM implementation in Russia during 2017-2019. The research, carried out in 2017 and 2019 included 2 blocks. The first of them is the telephone poll, which acted as the quantitative research. It allowed to extend the result for all the population owing to the volume and quality of the selection. The second block is the online questioning. Despite of rather huge number of the received questionnaires, this research is actually qualitative and it allows to establish the reasons of introduction or refusal of BIM, its main benefits, etc. The results of the research proved that the quantity of the organizations using BIM did not changed during d 2017-2019 and remained at the level of 22%. This result is interesting as the transfer from the accomplishment of the state order to accomplishment with obligatory application of building information modeling is indented in Russia. the explanation of the lack of the increase in the quantity of organizations using BIM. BIM introduction demands the considerable costs connected with the acquisition of equipment and software, retraining of personnel and often the organization restructuring. There results of the online questioning confirm that. During 201702019 the financial resources availability increased its influence considerably as the condition of BIM technologies implementation (among the organizations which are not using BIM). The improvement of works quality, the increase in the production efficiency (including reduction in cost and terms of works, the increase in economic return and profitability), search of ways of improving competitiveness, the requirement of the customer are the main reasons of BIM introduction (in decreasing order of the importance). The improved understanding of the project by all the participants, high quality of the project; availability of information, fast data transmission and exchange of information are noted as benefits of BIM application. It is noted, that most of respondents received the result, which exceeded their expectations thanks to BIM introduction: the excess of the result over expectations was observed by 77% of respondents in 2017 and by 80% of respondents in 2019.

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

Updated leg ulcer pathway: improving healing times and reducing costs

2019 ◽  
Vol 28 (20) ◽  
pp. S21-S26
Author(s):  
Leanne Atkin ◽  
Alison Schofield ◽  
Anita Kilroy-Findley
Keyword(s):  
Quality Of Life ◽  
Leg Ulcer ◽  
Leg Ulcers ◽  
Nursing Time ◽  
Venous Leg Ulcers ◽  
Reduced Costs ◽  
Reducing Costs

Regardless of the amount of literature and evidence on leg ulcer management, there are still significant variations in treatment. Implementing a standardised leg ulcer pathway to ensure patients are appropriately and timely assessed could help reduce nursing time and overall costs, while improving healing outcomes and patients' quality of life. Such a pathway was introduced in Lincolnshire and Leicestershire, UK, to treat venous leg ulcers (VLUs). The results showed improved healing times, reduced costs and fewer nurse visits, among other findings.

scholarly journals P121 The efficacy of treatment interventions on fatigue in adolescents with juvenile idiopathic arthritis: a literature review

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Sebastian Moshtael ◽  
Sonia Khanom ◽  
Janet E McDonagh
Keyword(s):  
Quality Of Life ◽  
Juvenile Idiopathic Arthritis ◽  
Young People ◽  
Rating Scale ◽  
Outcome Measure ◽  
Therapeutic Interventions ◽  
Current Evidence ◽  
Original Research ◽  
Qualitative Synthesis

Abstract Background/Aims  Fatigue has been reported by young people and professionals alike as a major challenge for people living with juvenile idiopathic arthritis (JIA) . It remains unclear as to how therapeutic interventions impacts on this major symptom. The aim of this review was to determine the current evidence for the effectiveness of therapeutic interventions, non- pharmacological and pharmacological, on improving fatigue in adolescents with JIA. Methods  Three electronic databases (MEDLINE, EMBASE, PsycINFO) were searched from 2000 to Feb 2020; in addition to manual searches. Articles were eligible for inclusion if they (i) were original research papers, (ii) had fatigue as a primary outcome measure (iii) included adolescents (10-25 years) and (iv) were available in the English language. Results  Of the 3,142 records identified, 31 underwent full text assessment and 4 studies were included in the qualitative synthesis including 2 from the Netherlands, 1 Germany, and 1 from Canada. The total number of participants across the 4 studies was 824. Three were randomised controlled trials of nonpharmacological interventions and one was a cohort study from a national drug registry including older adolescents JIA (mean: 19-years). Measurement tools included the Paediatric Quality of life multidimensional fatigue scale, (2 studies), the Checklist for Individual Strength CIS-20 (1 study), a numeric rating scale (1 study). In one study a visual analogue scale for energy level was also utilised. In 2 studies baseline prevalence of fatigue was reported as 60% and 76% respectively. Significant reduction in fatigue was observed in all three nonpharmacological studies. In the registry study, fatigue was noted to be prevalent in spite of the disease being in inactive or minimally active on biologic therapy. In 3 studies the relationship between health-related quality of life and fatigue was highlighted and showed a decreased quality of life in fatigued young people. Conclusion  Fatigue is a significant problem in JIA during adolescence and influences quality of life. Improvements in fatigue with non-pharmacological interventions have been reported. However, at present, data is insufficient to conclusively decide which treatment intervention is most efficacious in treating fatigue in young people with JIA. Fatigue should be considered as an important outcome measure for the management of JIA in future evaluations of interventions. Disclosure  S. Moshtael: None. S. Khanom: None. J.E. McDonagh: None.

scholarly journals Recent Advances in Myoelectric Control for Finger Prostheses for Multiple Finger Loss

2021 ◽  
Vol 11 (10) ◽  
pp. 4464
Author(s):  
Viritpon Srimaneepong ◽  
Artak Heboyan ◽  
Azeem Ul Yaqin Syed ◽  
Hai Anh Trinh ◽  
Pokpong Amornvit ◽  
...  
Keyword(s):  
Web Of Science ◽  
Myoelectric Control ◽  
Original Research ◽  
Prosthetic Hand ◽  
Precise Control ◽  
Prosthetic Hands ◽  
Prosthesis Retention ◽  
Finger Prosthesis ◽  
Artificial Hand

The loss of one or multiple fingers can lead to psychological problems as well as functional impairment. Various options exist for replacement and restoration after hand or finger loss. Prosthetic hand or finger prostheses improve esthetic outcomes and the quality of life for patients. Myoelectrically controlled hand prostheses have been used to attempt to produce different movements. The available articles (original research articles and review articles) on myoelectrically controlled finger/hand prostheses from January 1922 to February 2021 in English were reviewed using MEDLINE/PubMed, Web of Science, and ScienceDirect resources. The articles were searched using the keywords “finger/hand loss”, “finger prosthesis”, “myoelectric control”, and “prostheses” and relevant articles were selected. Myoelectric or electromyography (EMG) signals are read by myoelectrodes and the signals are amplified, from which the muscle’s naturally generated electricity can be measured. The control of the myoelectric (prosthetic) hands or fingers is important for artificial hand or finger movement; however, the precise control of prosthetic hands or fingers remains a problem. Rehabilitation after multiple finger loss is challenging. Implants in finger prostheses after multiple finger loss offer better finger prosthesis retention. This article presents an overview of myoelectric control regarding finger prosthesis for patients with finger implants following multiple finger loss.

Mindfulness-based stress reduction for people with chronic diseases

2010 ◽  
Vol 16 (3) ◽  
pp. 200 ◽  
Author(s):  
Monika Merkes
Keyword(s):  
Quality Of Life ◽  
Chronic Diseases ◽  
Stress Reduction ◽  
Well Being ◽  
Multiple Chemical Sensitivity ◽  
Self Report ◽  
Original Research ◽  
Mindfulness Based Stress Reduction ◽  
The Impact

Mindfulness-based stress reduction (MBSR) is a structured group program that uses mindfulness meditation to improve well-being and alleviate suffering. This article reviews the impact of MBSR for people with chronic diseases. The review includes original research that was published in English and peer-reviewed and reported outcomes for adults with chronic diseases who had participated in an MBSR program. Fifteen studies were identified. Outcomes related to mental and physical health, well-being, and quality of life. The studies included different research designs, and used self-report and physiological outcome measures. Participants’ clinical diagnoses included fibromyalgia, chronic pain, rheumatoid arthritis, type 2 diabetes, chronic fatigue syndrome, multiple chemical sensitivity, and cardiovascular diagnoses. All 15 studies found that participation in an MBSR program resulted in improvements. No negative change was reported between baseline and follow up. Outcomes in regard to specific variables were difficult to compare and equivocal. Overall, positive change predominated. Chronic diseases are associated with a range of unwelcome psychological and physical consequences. Participation in an MBSR program is likely to result in coping better with symptoms, improved overall well-being and quality of life, and enhanced health outcomes. As an adjunct to standard care, MBSR has potential for much wider application in Australian primary care settings.

Tool workspace consideration for assembly plan generation

2021 ◽  
Vol 41 (5) ◽  
pp. 612-625
Author(s):  
Akram Bedeoui ◽  
Riadh Ben Hadj ◽  
Moncef Hammadi ◽  
Nizar Aifaoui
Keyword(s):  
Collision Detection ◽  
New Product ◽  
Production Costs ◽  
Assembly Sequence ◽  
Content Type ◽  
Plan Generation ◽  
Assembly Sequences ◽  
Dynamic Interference ◽  
Time Decrease

Purpose During the design of a new product, the generation of assembly sequences plans (ASPs) has become one of the most important problems taken into account by researchers. In fact, a good mounting order allows the time decrease of the assembly process which leads to the reduction of production costs. In this context, researchers developed several methods to generate and optimize ASP based on various criteria. Although this paper aims to improve the quality of ASP it is necessary to increase the number of criteria which must be taken into account when generating ASPs. Design/methodology/approach In this paper, an ASP generation approach, which is based on three main algorithms, is proposed. The first one generates a set of assembly sequences based on stability criteria. The obtained results are treated by the second algorithm which is based on assembly tools (ATs) workspace criterion. An illustrative example is used to explain the different steps of this proposed approach. Moreover, a comparative study is done to highlight its advantages. Findings The proposed algorithm verifies, for each assembly sequence, the minimal required workspace of used AT and eliminates the ASPs non-respecting this criterion. Finally, the remaining assembly sequences are treated by the third algorithm to reduce the AT change during the mounting operation. Originality/value The proposed approach introduces the concept of AT workspace to simulate and select ASPs that respect this criterion. The dynamic interference process allows the eventual collision detection between tool and component and avoids it. The proposed approach reduces the AT change during the mounting operations.

Competitive Entry of Information Goods Under Quality Uncertainty

2021 ◽  
pp. 1-20
Author(s):  
Zan Zhang ◽  
Guofang Nan ◽  
Minqiang Li ◽  
Yong Tan
Keyword(s):  
Product Quality ◽  
New Product ◽  
High Price ◽  
Quality Uncertainty ◽  
Information Goods ◽  
Consumer Uncertainty ◽  
Willingness To Adopt ◽  
Marketing Activities ◽  
Very High

When confronted with a new product, consumers often find it difficult to predict how it will perform, and such uncertainty reduces consumers’ willingness to adopt the product. In this paper, we consider a market whereby consumers decide when and which product to buy, given that they know the product quality of the incumbent but are uncertain about that of the entrant. We investigate how consumer uncertainty about product quality affects firms’ behavior-based pricing and customer acquisition and retention dynamics. Using a two-period vertical model, we find that, under high-end encroachment, an increase in consumer uncertainty reduces the entrant’s profit and hurts the incumbent’s profit when the quality differential between the products is relatively small, whereas, under low-end encroachment, increasing uncertainty not only benefits the incumbent but also can favor the entrant. An important implication for entrants is that the marketing activities, which aim to reduce consumer uncertainty about product functionalities, may fail to improve profitability. We also find that the entrant lowers the price for uninformed customers and raises the price for repeat buyers under high-end encroachment but lowers the price for all customers under low-end encroachment. We further examine the subsidy strategy and show that, when the entrant’s product has a significant quality advantage and consumer uncertainty is high but not very high, the optimal strategy for the entrant is to acquire all consumers who do not buy from the incumbent by providing subsidies and to drop the low-valuation customers by means of a high price after their uncertainty is resolved.

scholarly journals DIGITALIZATION – A NEW REALITY IN LAW AND NEW THREATS

2020 ◽  
pp. 115-140
Author(s):  
И.Н. Куксин ◽  
В.Д. Хода
Keyword(s):  
Quality Of Life ◽  
Production Efficiency ◽  
Rapid Development ◽  
Russian Society ◽  
Modern Period

Современный период развития российского общества характеризуется укоренным развитием цифровизации, которая позволяет повысить эффективность производства и улучшить качество жизни населения страны. Вместе с тем интенсивное внедрение информационно-телекоммуникационные технологии и, в частности, искусственного интеллекта влечет не только благо, но и новые вызовы, риски, угрозы для общества. Авторы видит их минимизацию в совершенствовании нормотворческой и правоприменительной практики. The modern period of development of Russian society is characterized by the rapid development of digitalization, which allows increasing production efficiency and improving the quality of life of the country's population. At the same time, the intensive introduction of information and telecommunication technologies

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