scholarly journals Pre-filled syringes in developed and developing region: An insight into Regulatory considerations

2019 ◽  
Vol 7 (2) ◽  
pp. 42-50
Author(s):  
Anjali Kapoor ◽  
Geeta Aggarwal
Keyword(s):  
Review Process ◽  
Review Article ◽  
Single Application ◽  
Regulatory Pathways ◽  
Regulatory Guidelines ◽  
Developing Region ◽  
Regulatory Bodies ◽  
Unit Dose ◽  
Insight Into ◽  
Parenteral Medication

A Pre-filled syringe is a disposable syringe that is supplied already loaded with the substance to be injected. It is a unit dose of parenteral medication to which a needle has been fixed by a producer. They are small which make them easy to carry and are dependable for delivering a precise dose of medication. These reasons are leading to growth of parenteral medication in pharmaceutical market. The intent of this review article is to provide information on regulatory guidelines involved in submission approach for marketing authorization of pre-filled syringe in developed region (USA, EU) and developing region (India). It also further explains about complexities associated with Pre-filled syringes in terms of regulations, submission approaches and quality development considerations in developing region. There is a need to develop an effective regulatory framework to make regulations of Pre-filled syringes more comprehensive for regulatory bodies. A harmonized forum to be made through which single application can be made and single review process can be followed to avoid deviations in regulatory pathways.

Current Status of Biosimilar Regulations in the MENA Region

2020 ◽  
Vol 11 (3) ◽  
pp. 3443-3449 ◽  
Author(s):  
Ammar Almaaytah ◽  
Hadeia Mashaqbeh ◽  
Razan Haddad
Keyword(s):  
North Africa ◽  
Public Expenditure ◽  
Biological Therapy ◽  
Review Article ◽  
Current Status ◽  
Negative Consequences ◽  
Mena Region ◽  
Regulatory Pathways ◽  
Regulatory Guidelines ◽  
The World

This review article explores the regulatory situation of biosimilar registration pathways in the Middle East and North Africa (MENA). With most countries in the world have either adopted official regulatory guidelines for biosimilar approval or are in the process of developing such guidelines, countries in the MENA region are advised to accelerate the process of adopting pathways for biosimilar approval primarily for preventing the entry of intended copies into such markets and risking patients’ safety in addition to jeopardizing clinical outcomes of the different disease modalities that are treated by biologics. Additionally, biosimilars are playing a significant role in reducing the significant public expenditure on biological therapy and thus increasing the accessibility of these medications to a larger population of patients. The article details the countries in the MENA region that have adopted official and scientific guidelines for biosimilar approval pathways. The article also draws a comparison between different countries on issues such as comparability studies, extrapolation of indications, interchangeability and non-clinical quality requirements. In conclusion, only four countries out of the 15 countries they comprise the MENA region have adopted clear regulatory pathways for biosimilar registration and approval. This situation should be of urgent importance to policymakers responsible for public health bodies in countries that lack such guidelines due to the negative consequences that could result due to the absence of clear biosimilar regulations.

Upcoming Drifts In Bio-Similars

2020 ◽  
Vol 15 ◽  
Author(s):  
Geeta Aggarwal ◽  
Manju Nagpal ◽  
Ameya Sharma ◽  
Vivek Puri ◽  
Gitika Arora Dhingra
Keyword(s):  
Metabolic Diseases ◽  
Market Competition ◽  
Current Status ◽  
Medicinal Products ◽  
The Past ◽  
Biologic Activity ◽  
Emerging Trends ◽  
Regulatory Guidelines ◽  
Food Drug Administration ◽  
Insight Into

Background: Biopharmaceuticals such as Biologic medicinal products have been in clinical use over the past three decades and have benefited towards the therapy of degenerative and critical metabolic diseases. It is forecasted that market of biologics will be going to increase at a rate of 20% per year, and by 2025, more than ˃ 50% of new drug approvals may be biological products. The increasing utilization of the biologics necessitates for cost control, especially for innovators products that have enjoyed a lengthy period of exclusive use. As the first wave of biopharmaceuticals is expired or set to expire, it has led to various opportunities for the expansion of bio-similars i.e. copied versions of original biologics with same biologic activity. Development of biosimilars is expected to promote market competition, meet worldwide demand, sustain the healthcare systems and maintain the incentives for innovation. Methods: Appraisal of published articles from peer reviewed journals, PubMed literature, latest news and guidelines from European Medicine Agency, US Food Drug Administration (FDA) and India are used to identify data for review. Results: Main insight into the quality requirements concerning biologics, current status of regulation of biosimilars and upcoming challenges lying ahead for the upgrading of marketing authorization of bio-similars has been incorporated. Compiled literature on therapeutic status, regulatory guidelines and the emerging trends and opportunities of biosimilars has been thoroughly stated. Conclusion: Updates on biosimilars will support to investigate the possible impact of bio-similars on healthcare market.

Critical Insight into the Attributes of Emerging Novel Coronavirus (COVID-19) in India and Across the World

Coronaviruses ◽  
2020 ◽  
Vol 1 (1) ◽  
pp. 49-56
Author(s):  
Gaurav M. Doshi ◽  
Hemen S. Ved ◽  
Ami P. Thakkar
Keyword(s):  
Review Article ◽  
World Health ◽  
Effective Vaccine ◽  
Human Contact ◽  
The World ◽  
Critical Insight ◽  
Novel Coronavirus ◽  
Health Organization ◽  
Insight Into ◽  
Old Drugs

The World Health Organization (WHO) has recently announced the spread of novel coronavirus (nCoV) globally and has declared it a pandemic. The probable source of transmission of the virus, which is from animal to human and human to human contact, has been established. As per the statistics reported by the WHO on 11th April 2020, data has shown that more than sixteen lakh confirmed cases have been identified globally. The reported cases related to nCoV in India have been rising substantially. The review article discusses the characteristics of nCoV in detail with the probability of potentially effective old drugs that may inhibit the virus. The research may further emphasize and draw the attention of the world towards the development of an effective vaccine as well as alternative therapies. Moreover, the article will help to bridge the gap between the new researchers since it’s the current thrust area of research.

scholarly journals Multi-omic profiling of lung and liver tumor microenvironments of metastatic pancreatic cancer reveals site-specific immune regulatory pathways

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Won Jin Ho ◽  
Rossin Erbe ◽  
Ludmila Danilova ◽  
Zaw Phyo ◽  
Emma Bigelow ◽  
...  
Keyword(s):  
Mouse Model ◽  
Primary Tumors ◽  
Regulatory Pathways ◽  
Tumor Microenvironments ◽  
Clinical Responses ◽  
Cellular Pathways ◽  
Autopsy Specimens ◽  
Rapid Autopsy ◽  
Insight Into ◽  
Systemic Therapies

Abstract Background The majority of pancreatic ductal adenocarcinomas (PDAC) are diagnosed at the metastatic stage, and standard therapies have limited activity with a dismal 5-year survival rate of only 8%. The liver and lung are the most common sites of PDAC metastasis, and each have been differentially associated with prognoses and responses to systemic therapies. A deeper understanding of the molecular and cellular landscape within the tumor microenvironment (TME) metastasis at these different sites is critical to informing future therapeutic strategies against metastatic PDAC. Results By leveraging combined mass cytometry, immunohistochemistry, and RNA sequencing, we identify key regulatory pathways that distinguish the liver and lung TMEs in a preclinical mouse model of metastatic PDAC. We demonstrate that the lung TME generally exhibits higher levels of immune infiltration, immune activation, and pro-immune signaling pathways, whereas multiple immune-suppressive pathways are emphasized in the liver TME. We then perform further validation of these preclinical findings in paired human lung and liver metastatic samples using immunohistochemistry from PDAC rapid autopsy specimens. Finally, in silico validation with transfer learning between our mouse model and TCGA datasets further demonstrates that many of the site-associated features are detectable even in the context of different primary tumors. Conclusions Determining the distinctive immune-suppressive features in multiple liver and lung TME datasets provides further insight into the tissue specificity of molecular and cellular pathways, suggesting a potential mechanism underlying the discordant clinical responses that are often observed in metastatic diseases.

scholarly journals Salicylic acid and its role in induced plant resistance to biotic stress

2020 ◽  
Vol 131 (2) ◽  
pp. 8-14
Author(s):  
N.N. Iksat ◽  
◽  
D. Tokasheva ◽  
М.К. Beissekova ◽  
U.I. Amanbayeva ◽  
...  
Keyword(s):  
Salicylic Acid ◽  
Antioxidant Enzymes ◽  
Biotic Stress ◽  
Plant Protection ◽  
Plant Immunity ◽  
Review Article ◽  
Induced Plant Resistance ◽  
Protective Genes ◽  
Oxidative Processes ◽  
Insight Into

Salicylic acid is a natural signaling molecule that plays a key role in establishing and transmitting plant protection signals from phytopathogens. Salicylic acid, by modulating the expression of protective genes and changing the activity of antioxidant enzymes, can regulate oxidative processes associated with plant protective reactions. This review article reviews studies that provide insight into the functioning of salicylic acid in plant immunity

The Toxic Side of Nanotechnology: An Insight into Hazards to Health and the Ecosystem

2021 ◽  
Vol 13 ◽  
Author(s):  
Sarita Kumari Yadav ◽  
Zulfequar Ahmed Khan ◽  
Brahmeshwar Mishra ◽  
Shiv Bahadur ◽  
Ajay Kumar ◽  
...  
Keyword(s):  
Aquatic Organisms ◽  
Risk Assessments ◽  
Proper Treatment ◽  
Public And Private ◽  
Regulatory Guidelines ◽  
Assessment And Monitoring ◽  
Treatment And Disposal ◽  
Human And Nature ◽  
Insight Into ◽  
Detailed Nature

: The objective of the present article is to provide an insight into the toxicity aspect of Nanoparticles on health and ecosystem along with risk assessment and monitoring. After a detailed screening of various research reports from the peer-reviewed journals, books, and research news, the article was prepared. Due to nanotechnology's various significant advantages over conventional technologies, it has been explored for diverse research and commercial needs such as cosmetics, medical, pharmaceuticals, biotechnology, electronics, catalysts, robotics, and so on. However, nanotechnology has several challenging elements for the health, environmental, societal and economic aspects, and unpredictable consequences can happen due to its unknown detailed nature, which needs to be identified. Therefore, in this review, an attempt has been made to cover the two most important aspects of the toxicity of nanoparticles i.e. influence on health and the ecosystem. The health hazards to various organs, especially lungs, gastrointestinal tract and dermis and aquatic organisms, have been elaborated. Further, the ecotoxicological aspect describing fate, mechanism of ecotoxicity, ecotoxicological challenges and solutions to ecotoxicologist are discussed. Risk assessments, related to the approaches that can be used for the optimization of nanotechnology, are also mentioned. Its high time when nanotechnology field needs reconsideration and uncompromising attention at a public and private level about its use, handling, storage, proper treatment and disposal. Also, risk analysis and establishment of regulatory guidelines for optimization and safe practice of nanotechnology for human and nature welfare are recommended.

Making Design Review Interactive

2015 ◽  
pp. 234-257 ◽  
Author(s):  
Rojin S. Vishkaie ◽  
Richard M. Levy
Keyword(s):  
Digital Media ◽  
Final Stage ◽  
Review Process ◽  
Ongoing Study ◽  
Interactive Communication ◽  
Design Review ◽  
Participatory Communication ◽  
Interactive Surfaces ◽  
The Status ◽  
Insight Into

As a synthesis, this paper offers the opportunity to rethink the status of current technologies within the design review process. It suggests the potential for transforming the complex participatory, communicative, and technical nuances of the design review process to coexist with the affordances of the new genre of digital media. Thus, this paper presents the final stage of an ongoing study that focuses on the design and evaluation of an interactive communication medium, called SketchBoard, for the design review process. Findings reveal that SketchBoard that embodies intelligent and intelligible behavior could potentially remedy the vagueness of visualization. This could further provide an insight into improving participatory communication and visualization around technical activities within the design review process using mobile interactive surfaces.

scholarly journals Overview and Insights into Carbapenem Allergy

Pharmacy ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. 110 ◽  
Author(s):  
Yuman Lee ◽  
Nicole Bradley
Keyword(s):  
Case Reports ◽  
Review Article ◽  
Limited Data ◽  
Substantial Impact ◽  
Cross Sensitivity ◽  
Search Terms ◽  
Incidence Risk ◽  
Pubmed Search ◽  
The Individual ◽  
Insight Into

Understanding antibiotic allergies and the risk of cross-sensitivity between and within antibiotic classes can have a substantial impact on patient care. The purpose of this review article is to provide insight into carbapenem allergies, describing the overall incidence, risk factors, and in-class cross-sensitivity. A PubMed search was conducted using the following search terms: carbapenem, allergy, cross-sensitivity, incidence, imipenem/cilastatin, meropenem, ertapenem, and doripenem. Article bibliographies and relevant drug monographs were also reviewed. The overall reported incidence of carbapenem allergy is 0.3%–3.7%. Risk of cross-sensitivity between penicillins and carbapenems is less than 1% in patients with a positive penicillin skin test. Data on cross-sensitivity between cephalosporins and carbapenems are limited; however, the risk appears to also be low. No clinical studies have described cross-sensitivity between the carbapenem agents thus far. The limited data available from case reports demonstrates a lack of cross-sensitivity between the individual carbapenems, suggesting that an alternative carbapenem may cautiously be used in patients with a reported carbapenem allergy.

scholarly journals Metabolomic Insight into Polycystic Ovary Syndrome—An Overview

2020 ◽  
Vol 21 (14) ◽  
pp. 4853 ◽  
Author(s):  
Anna Rajska ◽  
Magdalena Buszewska-Forajta ◽  
Dominik Rachoń ◽  
Michał Jan Markuszewski
Keyword(s):  
Polycystic Ovary Syndrome ◽  
Metabolic Pathways ◽  
Polycystic Ovary ◽  
Review Article ◽  
Endocrine Disorders ◽  
Crucial Aspect ◽  
Ovary Syndrome ◽  
Metabolic Markers ◽  
Insight Into ◽  
Potential Biomarkers

Searching for the mechanisms of the polycystic ovary syndrome (PCOS) pathophysiology has become a crucial aspect of research performed in the last decades. However, the pathogenesis of this complex and heterogeneous endocrinopathy remains unknown. Thus, there is a need to investigate the metabolic pathways, which could be involved in the pathophysiology of PCOS and to find the metabolic markers of this disorder. The application of metabolomics gives a promising insight into the research on PCOS. It is a valuable and rapidly expanding tool, enabling the discovery of novel metabolites, which may be the potential biomarkers of several metabolic and endocrine disorders. The utilization of this approach could also improve the process of diagnosis and therefore, make treatment more effective. This review article aims to summarize actual and meaningful metabolomic studies in PCOS and point to the potential biomarkers detected in serum, urine, and follicular fluid of the affected women.

Atomic layer deposition and electrospinning as membrane surface engineering methods for water treatment: a short review

2020 ◽  
Vol 6 (7) ◽  
pp. 1765-1785
Author(s):  
Jieun Lee ◽  
In S. Kim ◽  
Moon-Hyun Hwang ◽  
Kyu-Jung Chae
Keyword(s):  
Water Treatment ◽  
Atomic Layer Deposition ◽  
Surface Engineering ◽  
Membrane Surface ◽  
Atomic Layer ◽  
Short Review ◽  
Review Article ◽  
Future Perspectives ◽  
Layer Deposition ◽  
Insight Into

This review article provides a summary of the application of ALD and electrospinning in membrane processes for water treatment and insight into the technological challenges and future perspectives for their wider application in the membrane industry.

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