scholarly journals Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA

2021 ◽  
Vol 8 ◽  
Author(s):  
Jeanne-Céleste Paquet ◽  
Sandrine P. Claus ◽  
Magali Cordaillat-Simmons ◽  
Wilfrid Mazier ◽  
Georges Rawadi ◽  
...  
Keyword(s):  
Clinical Stage ◽  
Development Phase ◽  
Human Beings ◽  
Efficacy Data ◽  
Single Strain ◽  
Innovative Products ◽  
Early Development Phase ◽  
Human Clinical Study ◽  
Regulatory Challenges

During the last decade, a plethora of novel therapies containing live microorganisms as active substance(s) has emerged with the aim to treat, prevent, or cure diseases in human beings. Both the Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines and Health Care (EDQM) codified these biotherapies as Live Biotherapeutic Products (LBPs). While these innovative products offer healthcare opportunities, they also represent a challenge for developers who need to set the most suitable designs for non-clinical and clinical studies in order to demonstrate a positive benefit/risk ratio through relevant quality, safety, and efficacy data that are expected by the drug competent authorities. This article describes how YSOPIA Bioscience, supported by the Pharmabiotic Research Institute (PRI), addressed the regulatory challenges during the early development phase of their single-strain LBP, Xla1, in order to obtain the necessary authorizations to bring this drug to the clinical stage.

PENGARUH PIJAT BAYI TERHADAP KUALITAS TIDUR BAYI UMUR 0 – 3 BULAN DI WILAYAH KERJA PUSKESMAS SOSIAL PALEMBANG TAHUN 2016

2019 ◽  
Vol 6 (2) ◽  
Author(s):  
Juliana Widyastuti Wahyuningsih Juliana Widyastuti Wahyuningsih
Keyword(s):  
Experimental Design ◽  
Growth And Development ◽  
Sampling Technique ◽  
P Value ◽  
Development Phase ◽  
Quality Of Sleep ◽  
Infant Massage ◽  
Before And After ◽  
The Brain

ABSTRAK Tidur merupakan kebutuhan yang harus terpenuhi terutama pada fase perkembangan karena selama tidur akan terjadi perkembangan otak maupun tubuh, sehingga gangguan tidur merupakan masalah yang akan menimbulkan dampak buruk terhadap pertumbuhan dan perkembangan bayi. Kualitas tidur bayi yang baik dapat diciptakan dengan memberikan pemijatan bayi secara rutin. Penelitian ini bertujuan untuk membuktikan bahwa pemijatan dapat mempengaruhi kualitas tidur bayi umur 0-3 bulan. Penelitian ini menggunakan desain penelitian Quasy Eksperimental dengan metode One Group Pretest-Postest. Sampel 22 bayi yang dipilih dengan tehnik Total Sampling yang di observasi sebelum dan sesudah diberikan pemijatan. Variabel yang diukur dalam penelitian ini adalah kualitas tidur bayi 0-3 bulan. Hasil penelitian menunjukkan bahwa ada pengaruh pijat bayi terhadap kualitas tidur bayi umur 0-3 bulan (p value  0,008 < α = 0,05).Berdasarkan hasil penelitian ini disarankan agar keluarga dan masyarakat memberikan pemijatan secara rutin dan mandiri untuk meningkatkan kebutuhan tidur bayi yang berkualitas.   ABSTRACT Sleep is a human necessity that must be met, especially in the development phase because during sleep will occur the brain and body developments, so that sleep disturbance is a problem that would cause adverse effects on infants’ growth and development. The good quality of sleep can be created by providing the infants massage routinely. This study aimed to prove that the massage could affect the quality of sleep on the 0-3 months old baby. This study used Quasy-experimental design with One Group Pretest-Posttest. The sample 22 infants selected by total sampling technique observed on before and after the massage. The variables measured in this study are the quality of sleep. The results of study indicate that there is an effect of infant massage to the sleep quality on 0-3 months old babies (p value 0,008 < α = 0,05).Based on the results of this study it recommended for the families and communities to provide infant massage regularly and independently to increase the quality of sleep on the baby.  

Formulating biossay data of chemicals and environmental water

2000 ◽  
Vol 42 (3-4) ◽  
pp. 115-123 ◽  
Author(s):  
R. Shoji ◽  
A. Sakoda ◽  
Y. Sakai ◽  
M. Suzuki
Keyword(s):  
Water Quality ◽  
Low Density Lipoprotein ◽  
Water Environment ◽  
Density Lipoprotein ◽  
Environmental Water ◽  
Toxicity Data ◽  
Human Beings ◽  
Environmental Waters ◽  
Bodies Of Water

The quality of environmental waters such as rivers is often deteriorated by various kinds of trace and unidentified chemicals despite the recent development of sewage systems and wastewater treatment technologies. In addition to contamination by particular toxicants, complex toxicity due to multi-component chemicals could be much more serious. The environmental situation in bodies of water in Japan led us to apply bioassays for monitoring the water quality of environmental waters in order to express the direct and potential toxicity to human beings and ecosystems rather than determinating concentrations of particular chemicals. However, problems arose from the fact that bioassays for pharmaceutical purposes generally required complicated, time-consuming, expert procedures. Also, a methodology for feedback of the resultant toxicity data to water environment management has not been established yet. To this end, we developed a novel bioassay based on the low-density lipoprotein (LDL) uptake activity of human hepatoblastoma cells. The assay enabled us to directly detect the toxicity of environmental waters within 4 hours of exposure. This is a significantly quick and easy procedure as compared to that of conventional bioassays. The toxicity data for 255 selected chemicals and environmental waters obtained by this method were organized by a mathematical equation in order to make those data much more effectively and practically useful to the management of environmental waters. Our methodology represents a promising example of applying bioassays to monitor environmental water quality and generating potential solutions to the toxicity problems encountered.

Yoga and Wellness—Key Insights from the Study on General Yoga Programme

2021 ◽  
Vol 14 (1) ◽  
pp. 51-63
Author(s):  
Rabindra Acharya ◽  
Gopal P. Mahapatra ◽  
Kadamibini Acharya
Keyword(s):  
Relevant Literature ◽  
Health And Wellness ◽  
Human Beings ◽  
Recent Past ◽  
Facilitative Role ◽  
Quality Of Living ◽  
The Impact ◽  
Simplified Form

Human beings have always strived towards excellence and progress since time immemorial. Industrialisation, automation and technological disruptions have led to increased comfort and quality of living of human beings and enhanced output, productivity and efficiency. Consequently, of late, health and wellness are receiving increased attention globally. Stress and stress-related diseases and workplace-related ailments have significantly increased over the last few decades and gained attention from society and industrial organisations. In the recent past, in the coronavirus pandemic context, wellness has been focused upon in many countries, communities and organisations worldwide. Yoga has been part of the Indian ethos for centuries. In this article, the authors discuss the General Yoga Programme (GYP), its broad coverage, and the impact it has had on the participants in terms of their wellness. With the help of a survey of the participants and linking it to relevant literature and research in the field, the authors highlight how GYP is a useful tool for enhancing various wellness dimensions. They recommend that GYP in its simplified form can be extended to the workplace; and also, HR professionals can play a facilitative role in the process.

Making Sense of Water Quality: Multispecies Encounters on the Mystic River

2013 ◽  
Vol 17 (2) ◽  
pp. 150-160 ◽  
Author(s):  
Caterina Scaramelli
Keyword(s):  
Water Quality ◽  
Laboratory Data ◽  
Quality Data ◽  
Human Beings ◽  
Water Lily ◽  
Water Quality Data ◽  
Water Flows ◽  
Making Sense ◽  
Quality Of Water

This paper takes water quality as an ethnographic subject. It looks at how water quality monitors in Boston make sense of the quality of water through mundane engagement with three non-human beings who they encounter during their monitoring activities: herring, bacteria and water lily. Each of these organisms suggests a different understanding of water quality for the monitors and poses a dilemma. Water quality monitors who contribute to the production of water quality data come to know water quality as through direct interactions with these beings, mediated by both sensorial experience and laboratory data. These experiences, at the same time, confuse and redraw relationships between science, water flows, non-human vitality, including that of invasive species, and people.

scholarly journals Current Nanocarrier Strategies Improve Vitamin B12 Pharmacokinetics, Ameliorate Patients’ Lives, and Reduce Costs

Nanomaterials ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 743
Author(s):  
Marco Fidaleo ◽  
Stefano Tacconi ◽  
Carolina Sbarigia ◽  
Daniele Passeri ◽  
Marco Rossi ◽  
...  
Keyword(s):  
Side Effects ◽  
Vitamin B12 ◽  
Memory Performance ◽  
Oral Route ◽  
High Dose ◽  
Human Beings ◽  
Inborn Errors ◽  
Essential Nutrient

Vitamin B12 (VitB12) is a naturally occurring compound produced by microorganisms and an essential nutrient for humans. Several papers highlight the role of VitB12 deficiency in bone and heart health, depression, memory performance, fertility, embryo development, and cancer, while VitB12 treatment is crucial for survival in inborn errors of VitB12 metabolism. VitB12 is administrated through intramuscular injection, thus impacting the patients’ lifestyle, although it is known that oral administration may meet the specific requirement even in the case of malabsorption. Furthermore, the high-dose injection of VitB12 does not ensure a constant dosage, while the oral route allows only 1.2% of the vitamin to be absorbed in human beings. Nanocarriers are promising nanotechnology that can enable therapies to be improved, reducing side effects. Today, nanocarrier strategies applied at VitB12 delivery are at the initial phase and aim to simplify administration, reduce costs, improve pharmacokinetics, and ameliorate the quality of patients’ lives. The safety of nanotechnologies is still under investigation and few treatments involving nanocarriers have been approved, so far. Here, we highlight the role of VitB12 in human metabolism and diseases, and the issues linked to its molecule properties, and discuss how nanocarriers can improve the therapy and supplementation of the vitamin and reduce possible side effects and limits.

scholarly journals National control laboratory independent lot testing of COVID-19 vaccines: the UK experience

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Nicola J. Rose ◽  
Paul Stickings ◽  
Silke Schepelmann ◽  
Marc J. A. Bailey ◽  
Chris Burns
Keyword(s):  
Clinical Trials ◽  
Vaccine Development ◽  
Regulatory Approval ◽  
Safety Measures ◽  
Discovery Research ◽  
Innovative Products ◽  
The Uk ◽  
Vaccine Availability ◽  
And Control

AbstractThe past 18 months have seen an unprecedented approach to vaccine development in the global effort against the COVID-19 pandemic. The process from discovery research, through clinical trials and regulatory approval often takes more than 10 years. However, the critical need to expedite vaccine availability in the pandemic has meant that new approaches to development, manufacturing, and regulation have been required: this has necessitated many stages of product development, clinical trials, and manufacturing to be undertaken in parallel at a global level. Through the development of these innovative products, the world has the best chance of finding individual, or combinations of, vaccines that will provide adequate protection for the world’s population. Despite the huge scientific and regulatory achievements and significant investment to accelerate vaccine availability, it is essential that safety measures are not compromised. Here we focus on the post regulatory approval testing by independent laboratories that provides an additional assurance of the safety and quality of a product, with an emphasis on the UK experience through the National Institute for Biological Standards and Control (NIBSC), an expert centre of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Treatment Efficacy

1996 ◽  
Vol 39 (5) ◽  
Author(s):  
Audrey L. Holland ◽  
Davida S. Fromm ◽  
Frank DeRuyter ◽  
Margo Stein
Keyword(s):  
Program Evaluation ◽  
Small Group ◽  
Research Design ◽  
Treatment Efficacy ◽  
Single Subject ◽  
Efficacy Data ◽  
Evaluation Data ◽  
Quality Of Evidence ◽  
Efficacy Of Treatment

This article presents a brief overview of aphasia, followed by a summary of research studies and program evaluation data addressed to answering the question of the efficacy of treatment for aphasia. Selected studies are reviewed in terms of the quality of evidence they present. In addition, a number of questions that remain unanswered are also presented. Several tables, designed to provide clarifying information concerning several aspects of research design (number and types of patients studied, examples of well-designed small-group or single-subject studies, clinical techniques for which efficacy data are available), are included. The conclusion of this review is that, generally, treatment for aphasia is efficacious.

The Digi-Table Method as a Tool for Reflecting on Research Ethics

2021 ◽  
Vol 66 (Special Issue) ◽  
pp. 177-177
Author(s):  
Wim Van Der Molen ◽  
◽  
Els Maeckelberghe ◽  
◽  
◽  
...  
Keyword(s):  
Research Ethics ◽  
Ethical Review ◽  
Scientific Integrity ◽  
Societal Impact ◽  
Educational Tool ◽  
Human Beings ◽  
Review Committee ◽  
Learning Content ◽  
Ethical Review Committee

"concepts and processes by means of a digitable. It is a tool for familiarizing users with complicated and complex issues, learning content, and addressing the more methodical aspects didactically. In this project, we have adapted the DTM for reflecting on research ethics, i.c. research with human beings and its ethical requirements and the review by the medical ethical review committee (MREC). A MREC reviews research proposals based on various (ethical) requirements and requires researchers to understand the ethical consequences and societal impact of their research. Before writing their own proposals, it is important for students to know and understand these ethical requirements and the process through which research proposals are reviewed. In order to train this, we prepared the digitable to simulate the review of a research protocol by an MREC and adapted it into an existing assignment on research ethics for master students. The students were informed of our aim and the use of DTM as an educational tool, and asked for consent. We invited them to critically assess the activity and we ensured participation would not influence their grade. The students reported a better understanding of the medical ethical review and felt it would improve their own work. From the educator’s perspective, the quality of argumentation of the review was much improved compared to previous years. The DTM as an educational tool is now a standard element in different master courses on scientific integrity. "

scholarly journals Nursing care using KT (Kuchi-kara Taberu) index radar chart enabling elderly patients with dysphagia to live like human beings after initiating gastrostomy feeding

2017 ◽  
Vol 27 (2) ◽  
pp. 136-138 ◽  
Author(s):  
Yumiko Aruga ◽  
Ayako Saito ◽  
Yuji Aoki
Keyword(s):  
Quality Of Life ◽  
Elderly Patients ◽  
Nursing Care ◽  
Percutaneous Endoscopic Gastrostomy ◽  
Family Members ◽  
Human Beings ◽  
Severe Dysphagia ◽  
Endoscopic Gastrostomy ◽  
Radar Chart

Some patients with severe dysphagia need to undergo percutaneous endoscopic gastrostomy (gastrostomy feeding), which improves nutrition but leads them to feel they are not living like human beings. The KT (Kuchi-kara Taberu, or ingesting orally in Japanese) index was developed in order to comprehensively assess and intervene in problems with eating and swallowing. We present three cases where the KT index improved quality of life after gastrostomy feeding. Through continued nursing care using the KT index, the patient in Case 1 was able to eat orally again; the patient in Case 2 could eat a piece of jelly and communicate a little; and the patient in Case 3 was able to ingest a small amount of food orally, with support from her husband. Thus, the feeding support provided by the KT index radar chart improves quality of life, even after the implementation of gastrostomy feeding. Further studies are needed to investigate how the KT index best helps elderly patients with severe dysphagia live like human beings while taking into account the perspectives of patients and their family members.

scholarly journals Perceptions of hospital admission in patients with cystic fibrosis

2013 ◽  
Vol 2 (3) ◽  
pp. 54 ◽  
Author(s):  
Merel Visse ◽  
Tineke Abma ◽  
Hetty Van den Oever ◽  
Yvonne Prins ◽  
Vincent Gulmans
Keyword(s):  
Cystic Fibrosis ◽  
Hospital Admission ◽  
Social Life ◽  
Well Being ◽  
Human Beings ◽  
Intravenous Injections ◽  
Societal Context ◽  
Normative Expectations ◽  
The Impact

Aims and objectives: This paper is a report of a study of experiences of people with Cystic Fibrosis (CF) with their hospital admission. It evaluates how they perceive their treatment and care and the impact on their social life (school or work). Background: In The Netherlands, people with CF are hospitalized in seven CF centers. In general, hospitalization may raise several challenges concerning the patient’s psychosocial well-being, before, during and after the admission. The admission of people with CF is complicated, because of segregated treatment and care that aims to prevent hospital-based cross-infection. Design: This article reports on a qualitative study. Methods: Data were collected during 2009 and 2010. Nineteen people with CF admitted for more than 5 days in one of the seven Dutch CF-centres participated. Results and conclusions: The findings are organized into five contexts with subthemes: Before admission & Arrival (1); Treatment & Care (2); Room & Stay (3); Discharge (4); Social & Societal context (5). The findings show that patients express a need for enhancing the quality of some treatments, like intravenous injections and patients express normative expectations of professionals that directly relate to their psychosocial well-being, e.g. they want to be ‘seen’ and treated as human beings and not solely as patients. They desire segregation policies to be consistent, whilst simultaneously they prefer flexible segregation guidelines. In general, respondents are satisfied with hospital facilities. The study reports on challenges concerning continuation of school and work during the admission. The paper is relevant to every hospital where people are being nursed in isolation.

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