scholarly journals Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process

Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1051
Author(s):  
Jonattan Gallegos-Catalán ◽  
Zachary Warnken ◽  
Tania F. Bahamondez-Canas ◽  
Daniel Moraga-Espinoza
Keyword(s):  
New Technologies ◽  
Innovation Process ◽  
Cost Effective ◽  
Regulatory Agencies ◽  
Drug Products ◽  
Effective Strategies ◽  
Rate Analysis ◽  
Orally Inhaled Drug Products ◽  
Next Generation Impactor ◽  
First Time

Orally inhaled drug products (OIDPs) are an important group of medicines traditionally used to treat pulmonary diseases. Over the past decade, this trend has broadened, increasing their use in other conditions such as diabetes, expanding the interest in this administration route. Thus, the bioequivalence of OIDPs is more important than ever, aiming to increase access to affordable, safe and effective medicines, which translates into better public health policies. However, regulatory agencies leading the bioequivalence process are still deciding the best approach for ensuring a proposed inhalable product is bioequivalent. This lack of agreement translates into less cost-effective strategies to determine bioequivalence, discouraging innovation in this field. The Next-Generation Impactor (NGI) is an example of the slow pace at which the inhalation field evolves. The NGI was officially implemented in 2003, being the last equipment innovation for OIDP characterization. Even though it was a breakthrough in the field, it did not solve other deficiencies of the BE process such as dissolution rate analysis on physiologically relevant conditions, being the last attempt of transferring technology into the field. This review aims to reveal the steps required for innovation in the regulations defining the bioequivalence of OIDPs, elucidating the pitfalls of implementing new technologies in the current standards. To do so, we collected the opinion of experts from the literature to explain these trends, showing, for the first time, the stakeholders of the OIDP market. This review analyzes the stakeholders involved in the development, improvement and implementation of methodologies that can help assess bioequivalence between OIDPs. Additionally, it presents a list of methods potentially useful to overcome some of the current limitations of the bioequivalence standard methodologies. Finally, we review one of the most revolutionary approaches, the inhaled Biopharmaceutical Classification System (IBCs), which can help establish priorities and order in both the innovation process and in regulations for OIDPs.

3D Printing in Pharmaceuticals: Regulatory Perspective

2019 ◽  
Vol 24 (42) ◽  
pp. 5081-5083 ◽  
Author(s):  
Mohd. A. Mirza ◽  
Zeenat Iqbal
Keyword(s):  
New Technologies ◽  
Pharmaceutical Product ◽  
Regulatory Agencies ◽  
Major Research ◽  
Data Bases ◽  
Drug Products ◽  
Regulatory Perspective ◽  
Regulatory Guidelines ◽  
Recent Developments ◽  
Technical Issues

Background: The last few decades have witnessed enormous advancements in the field of Pharmaceutical drug, design and delivery. One of the recent developments is the advent of 3DP technology. It has earlier been successfully employed in fields like aerospace, architecture, tissue engineering, biomedical research, medical device and others, has recently forayed into the pharmaceutical industry.Commonly understood as an additive manufacturing technology, 3DP aims at delivering customized drug products and is the most acceptable form of“personalized medicine”. Methods: Data bases and search engines of regulatory agencies like USFDA and EMA have been searched thoroughly for relevant guidelines and approved products. Other portals like PubMed and Google Scholar were also ferreted for any relevant repository of publications are referred to wherever required. Results: So far only one pharmaceutical product has been approved in this category by USFDA and stringent regulatory agencies are working over the drafting of guidelines and technical issues. Major research of this category belongs to the academic domain. Conclusion: It is also implicit to such new technologies that there would be numerous challenges and doubts before these are accepted as safe and efficacious. The situation demands concerted and cautious efforts to bring in foolproof regulatory guidelines which would ultimately lead to the success of this revolutionary technology.

scholarly journals International Regulations for Bioequivalence Approval of Locally Acting Orally Inhaled Drug Products

2021 ◽  
Author(s):  
Dr. Vinod Gaikwad ◽  
Prajakta Patil ◽  
Atmaram Pawar ◽  
Kakasaheb Mahadik
Keyword(s):  
In Vivo Studies ◽  
Regulatory Agencies ◽  
European Medicines Agency ◽  
Drug Products ◽  
International Regulations ◽  
Orally Inhaled Drug Products ◽  
Drug Regulatory Agencies ◽  
Health Canada

Bioequivalence (BE) is established between the brand drug and the generic drug to allow the linking of preclinical and clinical testing conducted on the reference listed drug. Regulatory agencies around the globe have come up with the guidance for locally acting orally inhaled drug products (OIDPs) for bioequivalence approaches. The prime intent of the present article is to compare approaches of different international regulatory authorities such as Health Canada, European Medicines Agency and the US Food and Drug Administration that have published guidance related to locally acting OIDPs. Moreover, the Central Drugs Standard Control Organisation, India, has published guidelines for bioavailability and bioequivalence studies. BE recommendations from global regulatory agencies were based on comparison for different parameters, namely inhaler device, formulation, reference product’s selection, in-vitro as well as in-vivo studies (pharmacokinetics, pharmacodynamics, and clinical studies). In the case of in-vivo studies, details about study design, dose choices, inclusion/ exclusion criteria of the subject, study period, endpoint study, and equivalence acceptance criteria were discussed in the present review article.

Bioavailability of phosphorus as a tool for efficient P reduction schemes

1998 ◽  
Vol 37 (3) ◽  
pp. 241-247 ◽  
Author(s):  
Peter Gerdes ◽  
Sabine Kunst
Keyword(s):  
Sewage Treatment ◽  
Cost Effective ◽  
Effective Management ◽  
Lower Saxony ◽  
Effective Strategies ◽  
P Balance ◽  
Different Sources ◽  
Total P ◽  
P Sources ◽  
P Bioavailability

The bioavailability of phosphorus from different sources has been evaluated in the catchment area of the River Ilmenau (Lower-Saxony, Germany) by using algal assays. The P bioavailability describes the different potential of P from various sources of supporting eutrophication. Effluents from sewage treatment plants were highly bioavailable (72% of TP) whereas rainwater (26%) and erosion effluents (30%) showed a low bioavailability. In order to develop effective strategies to minimize P inputs into the river, source specific P bioavailability indices were determined and combined with a P balance to calculate inputs of vioavailable P (BAP) instead of total P (TP). It could be shown that the relative importance of the different P sources changes when applying BAP. Measures to reduce P inputs into the River Ilmenau will take P bioavailability into consideration and therefore lead to a more cost-effective management.

Green Synthesis and Spectroscopic Studies of Ag-rGO Nanocomposites for Highly Selective Mercury (II) Sensing

2018 ◽  
Vol 9 (1) ◽  
pp. 101-108 ◽  
Author(s):  
Shubhangi J. Mane-Gavade ◽  
Sandip R. Sabale ◽  
Xiao-Ying Yu ◽  
Gurunath H. Nikam ◽  
Bhaskar V. Tamhankar
Keyword(s):  
Green Synthesis ◽  
Color Change ◽  
Limit Of Detection ◽  
Aqueous Media ◽  
Suitable Condition ◽  
Cost Effective ◽  
Spectroscopic Studies ◽  
Calibration Plot ◽  
First Time

Introduction: Herein we report the green synthesis and characterization of silverreduced graphene oxide nanocomposites (Ag-rGO) using Acacia nilotica gum for the first time. Experimental: We demonstrate the Hg2+ ions sensing ability of the Ag-rGO nanocomposites form aqueous medium. The developed colorimetric sensor method is simple, fast and selective for the detection of Hg2+ ions in aqueous media in presence of other associated ions. A significant color change was noticed with naked eye upon Hg2+ addition. The color change was not observed for cations including Sr2+, Ni2+, Cd2+, Pb2+, Mg2+, Ca2+, Fe2+, Ba2+ and Mn2+indicating that only Hg2+ shows a strong interaction with Ag-rGO nanocomposites. Under the most suitable condition, the calibration plot (A0-A) against concentration of Hg2+ was linear in the range of 0.1-1.0 ppm with a correlation coefficient (R2) value 0.9998. Results & Conclusion The concentration of Hg2+ was quantitatively determined with the Limit of Detection (LOD) of 0.85 ppm. Also, this method shows excellent selectivity towards Hg2+ over nine other cations tested. Moreover, the method offers a new cost effective, rapid and simple approach for the detection of Hg2+ in water samples.

Conference report: innovation, interaction … and a lot of data: first time reflections on Internet Librarian International, UK 2018

2019 ◽  
Vol 36 (2) ◽  
pp. 21-22
Author(s):  
Ray Harper
Keyword(s):  
Best Practice ◽  
New Technologies ◽  
Conference Report ◽  
Library Services ◽  
New Techniques ◽  
Content Type ◽  
Making A Difference ◽  
Analyse Data ◽  
Physical Spaces ◽  
First Time

Purpose The purpose of this paper is to summarise a number of presentations at Day 1 of the Internet Librarian International conference, London, UK (16 October 2018). This was the 20th conference in the series, and the three key themes included were the next-gen library and librarian; understanding users, usage and user experience; and inclusion and inspiration: libraries making a difference. Design/methodology/approach This paper reports from the viewpoint of a first-time attendee of the conference. This summarises the main issues raised by each presentation and draws out the key learning points for practical situations. Findings The conference covered a variety of practical ways in which libraries can use technology to support users and make decisions about services. These include developing interactive physical spaces which include augmented reality; introducing “chat-bots” to support users; using new techniques to analyse data; and piloting new ways to engage users (such as coding clubs). A key theme was how we use and harness data in a way that is ethical, effective and relevant to library services. Originality/value This conference focussed on practical examples of how library and information services across sectors and countries are innovating in a period of huge change. The conference gave delegates numerous useful ideas and examples of best practice and demonstrated the strength of the profession in adapting to new technologies and developments.

scholarly journals Platforms for Production of Protein-Based Vaccines: From Classical to Next-Generation Strategies

Biomolecules ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. 1072
Author(s):  
Raquel Cid ◽  
Jorge Bolívar
Keyword(s):  
Infectious Diseases ◽  
Mammalian Cells ◽  
Vaccine Development ◽  
Low Cost ◽  
Cost Effective ◽  
Insect Larvae ◽  
Subunit Vaccines ◽  
Effective Strategies ◽  
Alternative Systems ◽  
Inactivated Vaccines

To date, vaccination has become one of the most effective strategies to control and reduce infectious diseases, preventing millions of deaths worldwide. The earliest vaccines were developed as live-attenuated or inactivated pathogens, and, although they still represent the most extended human vaccine types, they also face some issues, such as the potential to revert to a pathogenic form of live-attenuated formulations or the weaker immune response associated with inactivated vaccines. Advances in genetic engineering have enabled improvements in vaccine design and strategies, such as recombinant subunit vaccines, have emerged, expanding the number of diseases that can be prevented. Moreover, antigen display systems such as VLPs or those designed by nanotechnology have improved the efficacy of subunit vaccines. Platforms for the production of recombinant vaccines have also evolved from the first hosts, Escherichia coli and Saccharomyces cerevisiae, to insect or mammalian cells. Traditional bacterial and yeast systems have been improved by engineering and new systems based on plants or insect larvae have emerged as alternative, low-cost platforms. Vaccine development is still time-consuming and costly, and alternative systems that can offer cost-effective and faster processes are demanding to address infectious diseases that still do not have a treatment and to face possible future pandemics.

scholarly journals 400 - Effects of Computerized Cognitive Training with an Elderly Community Sample

2020 ◽  
Vol 32 (S1) ◽  
pp. 116-116
Author(s):  
M Pires ◽  
A Antunes ◽  
C Gameiro ◽  
C Pombo
Keyword(s):  
Older Adults ◽  
Cognitive Training ◽  
New Technologies ◽  
Community Sample ◽  
Cost Effective ◽  
Well Being ◽  
Control Group ◽  
Depression Symptoms ◽  
Intensive Training ◽  
Before And After

Community-focused programs that promote active and healthy aging can help preserve cognitive capacities, prevent or reverse cognitive deficits. Computer-based cognitive training (CCT) is a promising non-pharmacological, cost -effective and accessible intervention to face the effects of age-related cognitive decline. Previous studies proved CCT to have equal or better efficacy compared to traditional interventions. This comparative multifactorial study aims to test the efficacy of a CCT in a non-randomized community sample of 74 older adults: G1-CCT Experimental group (n=43) (Mean age M=72.21, SD=12.65) and G2- Paper-Pencil Control group (n=31; M=77.94, SD=10.51). Pensioners (97.3%), mostly women (83.8 %) with basic education (51.4%) and without dementia diagnosis, completed a cognitive training program of 17 or 34 group sessions (twice a week). G2 undertook a classic cognitive paper-pencil stimuli tasks. G1, performed, additionally, individual CCT with COGWEB® in a multimodal format (intensive training of attention, calculation, memory, gnosis, praxis, executive functions). Both groups completed Portuguese versions of Mini -Mental State Examination (MMSE),Montreal Cognitive Assessment (MOCA); Geriatric Depressive Scale (GDS); Mini Dependence Assessment (MDA); WHOOQL 5 and Social Support Satisfaction Scale (ESSS) before and after participating in the program. Both groups reported better post-test scores on basic cognitive functions (MMSE, MOCA), Depression symptoms (GDS-30), subjective well-being and quality of life (WHOOQL-5). G1 presented higher MOCA and lower GDS scores before and after CCT, although, group differences become less expressive when interaction effects are considered. Results are in line with findings from past studies, CCT supported by the new technologies, is as a relevant cost-effective therapeutic tool for health professionals working with older adults. Particularly for preventive purposes of neuro-cognitive disorders.

Business model of garment enterprises: a scientometric review

2021 ◽  
Vol 91 (13-14) ◽  
pp. 1609-1626
Author(s):  
Yuran Jin ◽  
Xiangye Song ◽  
Jinhuan Tang ◽  
Xiaodong Dong ◽  
Huisheng Ji
Keyword(s):  
Conference Proceedings ◽  
Social Science ◽  
Business Model ◽  
Western Europe ◽  
Business Models ◽  
New Technologies ◽  
Citation Index ◽  
The United States ◽  
Fast Fashion ◽  
First Time

The research on the business model of garment enterprises (BMGE) has expanded rapidly in the last decade. However, there is still a lack of comprehensive reviews of it, let alone visual research. Based on scientometrics, in this paper 118 papers and their 4803 references from Science Citation Index Expanded, Social Sciences Citation Index, Conference Proceedings Citation Index—Science, and Conference Proceedings Citation Index—Social Science & Humanities for the period 2010–2020 about the BMGE were analyzed by visualizing the co-cited references, co-occurrence keywords, burst references, dual-map overlays, and more with CiteSpace, Google Maps, and VOSviewer. The research revealed the intellectual landscapes of the BMGE for the first time and mapped the landmark papers, hotspots and trends, national or regional distributions and their cooperation networks, highly cited authors, and prestigious journals and disciplines related to the BMGE. The results show that the biggest hotspot is the fast fashion business model; social responsibility, smart fashion, Internet of Things, and sharing fashion are the main emerging hotspots; and the research focuses has evolved from traditional business models to business models driven by new technologies, then to new issues such as circular economy models. The institutions are mainly distributed in China, the United States, and Western Europe, and there is cooperation between more than 11 countries. The most popular disciplines are economics and politics, while psychology, education, and social science are the essential basic disciplines. The Journal of Cleaner Production and Journal of Fashion Marketing and Management, among others, actively promoted the research.

scholarly journals Facile Green, Room-Temperature Synthesis of Gold Nanoparticles Using Combretum erythrophyllum Leaf Extract: Antibacterial and Cell Viability Studies against Normal and Cancerous Cells

Antibiotics ◽  
2021 ◽  
Vol 10 (8) ◽  
pp. 893
Author(s):  
Olufunto T. Fanoro ◽  
Sundararajan Parani ◽  
Rodney Maluleke ◽  
Thabang C. Lebepe ◽  
Jose R. Varghese ◽  
...  
Keyword(s):  
Gold Nanoparticles ◽  
Cell Viability ◽  
Leaf Extract ◽  
Room Temperature ◽  
Klebsiella Oxytoca ◽  
Cost Effective ◽  
Average Diameter ◽  
Antibacterial Activities ◽  
Inhibition Concentration ◽  
First Time

We herein report a facile, green, cost-effective, plant-mediated synthesis of gold nanoparticles (AuNPs) for the first time using Combretum erythrophyllum (CE) plant leaves. The synthesis was conducted at room temperature using CE leaf extract serving as a reducing and capping agent. The as-synthesized AuNPs were found to be crystalline, well dispersed, and spherical in shape with an average diameter of 13.20 nm and an excellent stability of over 60 days. The AuNPs showed broad-spectrum antibacterial activities against both pathogenic Gram-positive (Staphylococcus epidermidis (ATCC14990), Staphylococcus aureus (ATCC 25923), Mycobacterium smegmatis (MC 215)) and Gram-negative bacteria (Proteus mirabilis (ATCC 7002), Escherichia coli (ATCC 25922), Klebsiella pneumoniae (ATCC 13822), Klebsiella oxytoca (ATCC 8724)), with a minimum inhibition concentration of 62.5 µg/mL. In addition, the as-synthesized AuNPs were highly stable with exceptional cell viability towards normal cells (BHK- 21) and cancerous cancer cell lines (cervical and lung cancer).

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