scholarly journals ARRONAX Cyclotron: Setting up of In-House Hospital Radiopharmacy

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Aurelien Vidal ◽  
Cécile Bourdeau ◽  
Mathieu Frindel ◽  
Tracy Garcia ◽  
Ferid Haddad ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Nuclear Medicine ◽  
Large Scale ◽  
Local Level ◽  
New Drugs ◽  
Proof Of Concept ◽  
Regulatory Requirements ◽  
Aseptic Processing ◽  
Pharmaceutical Processing ◽  
Hospital Production

Whilst radiopharmaceuticals have an important role to play in both imaging and treatment of patients, most notably cancer patients, nuclear medicine and radiopharmacy are currently facing challenges to create innovative new drugs. Traditional radiopharmaceutical manufacture can be considered as either a routine hospital production or a large-scale industrial production. The gap between these two practices has meant that there is an inability to supply innovative radiopharmaceuticals for use at the local level for mono- or multicentric clinical trials with satisfactory quality and safety specifications. This article highlights the regulatory requirements in aseptic pharmaceutical processing and in nuclear medicine to be able to locally produce radiopharmaceuticals. We validate the proof-of-concept for an “in-house” hospital-based radiopharmacy including an on-site cyclotron, that can fulfill the conflicting requirements between radiation safety and aseptic processing. The ARRONAX in-house radiopharmacy is currently able to provide sterile and pyrogenic-free injectable radiopharmaceutical compounds for both industrial and institutional clinical trials.

Chinese Pharmacopoeia Revisited: A Review of Anti-Depression Herbal Sources

2021 ◽  
Vol 16 (12) ◽  
pp. 1934578X2110593
Author(s):  
Dongyi Hu ◽  
Jiayu Gao ◽  
Xiao Yang ◽  
Ying Liang
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Life Quality ◽  
Herbal Medicines ◽  
Antidepressant Drugs ◽  
New Drugs ◽  
Chinese Herbs ◽  
Evidence Based ◽  
Chinese Pharmacopoeia ◽  
Bupleuri Radix

Depression, which can be accompanied by many fatal diseases and a low life quality, has become the leading cause of ill health and disability worldwide. However, Chinese Pharmacopoeia, the most authoritative and evidence-based encyclopedia of Traditional Chinese Medicine (TCM), could contain leads and insights into the development of new antidepressant drugs. In this work, nine herbal medicines with ‘dispel melancholy functions’ specifically documented in Chinese Pharmacopoeia have been comprehensively reviewed with respect to clinical trials, and phytochemical and pharmacological aspects. The nine drugs are Rosae Chinensis Flos, Croci Stigma, Albiziae Cortex and Flos, Roase Rugosae Flos, Curcumae Radix, Hyperici Perforati Herba, Cyperi Rhizoma and Bupleuri Radix. The mechanisms of action of their functional antidepressant compounds, including gallic acid, hypericin, kaempferol, crocetin, crocin, quercetin, luteolin, isorhamnetin, curcumin, hyperforin, adhyperforin, catechin, rutin, puerarin, and saikosaponins A and D, have been collected and discussed. These traditional Chinese herbs and their active compounds provide a promising resource to develop effective new antidepressant drugs in future. Moreover, mechanistic investigations, safety verification and large-scale clinical trials are still expected to finally transform such TCM-based antidepressant resources to new drugs for patients suffering from depression.

scholarly journals Assessing the legal duty to use or disclose interim data for ongoing clinical trials

2019 ◽  
Vol 6 (1) ◽  
pp. 51-84
Author(s):  
Lisa Eckstein
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Large Scale ◽  
Clinical Trial Data ◽  
New Drugs ◽  
Therapeutic Interventions ◽  
Scientific Integrity ◽  
Randomized Controlled Clinical Trials ◽  
Legal Obligations ◽  
Legal Duty

Abstract Randomized controlled clinical trials, leading to large-scale meta-analyses, are considered the gold standard for research evaluating new drugs and other therapeutic interventions. To promote scientific integrity and prevent the adoption of potentially fallacious early trends, emerging information is commonly shielded from sponsors, investigators, and other clinical trial actors, including through the use of independent Data and Safety Monitoring Boards (DSMBs). Once established, a DSMB is usually the only body to have access to unblinded information until trial completion or the crossing of pre-specified, and often highly stringent, stopping boundaries. Yet, in certain circumstances, clinical trial actors have legal obligations to trial participants and others to use or disclose emerging information. This paper canvasses potential legal obligations to use or disclose emerging clinical trial data, including through tort law and securities laws. The analysis is supplemented by a comprehensive search of US cases in which courts have adjudicated upon such allegations. Notably, available cases demonstrate widespread judicial deference to clinical trial practices designed to shield clinical trial actors from emerging information. As a result, despite a theoretical possibility of legal obligations of use or disclosure, it appears that these will rarely be enforceable.

DESIGN OF EARLY CLINICAL TRIALS FOR NEW CONTRACEPTIVE METHODS

1974 ◽  
Vol 77 (1_Suppla) ◽  
pp. S266-S278
Author(s):  
Daniel R. Mishell ◽  
Harold A. Nash
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Clinical Investigation ◽  
Toxicity Testing ◽  
Field Trials ◽  
New Drugs ◽  
Animal Testing ◽  
Good Continuation ◽  
Large Scale Field ◽  
Pharmaceutical Agents

ABSTRACT A plan is outlined to shorten the current suggested duration of animal testing prior to clinical investigation with certain types of pharmaceutical agents. For many new drugs, especially steroids, after a pharmacologic profile is established, long term toxicity testing can usually be shortened prior to initiation of 6 months clinical trials involving about 1000 women. Clinical trials of this magnitude usually correlate very well with ultimate performance of contraceptive drugs, provided proper selection of subjects is performed with resultant good continuation rates. It is thus possible with certain new antifertility candidates to safely shorten the duration of both toxicological and clinical studies before initiating large scale field trials.

Impact of COVID-19 on Nuclear Medicine in Germany, Austria and Switzerland: An International Survey in April 2020

2020 ◽  
Vol 59 (04) ◽  
pp. 294-299 ◽  
Author(s):  
Lutz S. Freudenberg ◽  
Ulf Dittmer ◽  
Ken Herrmann
Keyword(s):  
Nuclear Medicine ◽  
Health Systems ◽  
Personal Protective Equipment ◽  
Large Scale ◽  
Diagnostic Procedures ◽  
Protective Equipment ◽  
Current Crisis ◽  
Web Based ◽  
Public Versus Private ◽  
The Impact

Abstract Introduction Preparations of health systems to accommodate large number of severely ill COVID-19 patients in March/April 2020 has a significant impact on nuclear medicine departments. Materials and Methods A web-based questionnaire was designed to differentiate the impact of the pandemic on inpatient and outpatient nuclear medicine operations and on public versus private health systems, respectively. Questions were addressing the following issues: impact on nuclear medicine diagnostics and therapy, use of recommendations, personal protective equipment, and organizational adaptations. The survey was available for 6 days and closed on April 20, 2020. Results 113 complete responses were recorded. Nearly all participants (97 %) report a decline of nuclear medicine diagnostic procedures. The mean reduction in the last three weeks for PET/CT, scintigraphies of bone, myocardium, lung thyroid, sentinel lymph-node are –14.4 %, –47.2 %, –47.5 %, –40.7 %, –58.4 %, and –25.2 % respectively. Furthermore, 76 % of the participants report a reduction in therapies especially for benign thyroid disease (-41.8 %) and radiosynoviorthesis (–53.8 %) while tumor therapies remained mainly stable. 48 % of the participants report a shortage of personal protective equipment. Conclusions Nuclear medicine services are notably reduced 3 weeks after the SARS-CoV-2 pandemic reached Germany, Austria and Switzerland on a large scale. We must be aware that the current crisis will also have a significant economic impact on the healthcare system. As the survey cannot adapt to daily dynamic changes in priorities, it serves as a first snapshot requiring follow-up studies and comparisons with other countries and regions.

Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

2001 ◽  
Vol 21 (02) ◽  
pp. 77-81 ◽  
Author(s):  
G. Finazzi
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Collaborative Study ◽  
Clinical Problem ◽  
Vascular Events ◽  
Dose Oral ◽  
Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

Characterization of seawater reverse osmosis fouled membranes from large scale commercial desalination plant

2019 ◽  
Author(s):  
Chem Int
Keyword(s):  
Reverse Osmosis ◽  
Large Scale ◽  
Retention Rate ◽  
Local Level ◽  
Microscopic Analysis ◽  
Transmembrane Pressure ◽  
Hydraulic Permeability ◽  
Seawater Reverse Osmosis ◽  
A Chain

The objective of this work is to study the ageing state of a used reverse osmosis (RO) membrane taken in Algeria from the Benisaf Water Company seawater desalination unit. The study consists of an autopsy procedure used to perform a chain of analyses on a membrane sheet. Wear of the membrane is characterized by a degradation of its performance due to a significant increase in hydraulic permeability (25%) and pressure drop as well as a decrease in salt retention (10% to 30%). In most cases the effects of ageing are little or poorly known at the local level and global measurements such as (flux, transmembrane pressure, permeate flow, retention rate, etc.) do not allow characterization. Therefore, a used RO (reverse osmosis) membrane was selected at the site to perform the membrane autopsy tests. These tests make it possible to analyze and identify the cause as well as to understand the links between performance degradation observed at the macroscopic scale and at the scale at which ageing takes place. External and internal visual observations allow seeing the state of degradation. Microscopic analysis of the used membranes surface shows the importance of fouling. In addition, quantification and identification analyses determine a high fouling rate in the used membrane whose foulants is of inorganic and organic nature. Moreover, the analyses proved the presence of a biofilm composed of protein.

A Drug Target Interaction Prediction Based on LINE-RF Learning

2020 ◽  
Vol 15 (7) ◽  
pp. 750-757
Author(s):  
Jihong Wang ◽  
Yue Shi ◽  
Xiaodan Wang ◽  
Huiyou Chang
Keyword(s):  
Network Topology ◽  
Drug Target ◽  
Large Scale ◽  
Representation Learning ◽  
New Drugs ◽  
Combination Method ◽  
Learning Methods ◽  
Network Representation ◽  
On Line ◽  
Clinical Experiments

Background: At present, using computer methods to predict drug-target interactions (DTIs) is a very important step in the discovery of new drugs and drug relocation processes. The potential DTIs identified by machine learning methods can provide guidance in biochemical or clinical experiments. Objective: The goal of this article is to combine the latest network representation learning methods for drug-target prediction research, improve model prediction capabilities, and promote new drug development. Methods: We use large-scale information network embedding (LINE) method to extract network topology features of drugs, targets, diseases, etc., integrate features obtained from heterogeneous networks, construct binary classification samples, and use random forest (RF) method to predict DTIs. Results: The experiments in this paper compare the common classifiers of RF, LR, and SVM, as well as the typical network representation learning methods of LINE, Node2Vec, and DeepWalk. It can be seen that the combined method LINE-RF achieves the best results, reaching an AUC of 0.9349 and an AUPR of 0.9016. Conclusion: The learning method based on LINE network can effectively learn drugs, targets, diseases and other hidden features from the network topology. The combination of features learned through multiple networks can enhance the expression ability. RF is an effective method of supervised learning. Therefore, the Line-RF combination method is a widely applicable method.

scholarly journals Coopetitive Nature of Energy Communities—The Energy Transition Context

Energies ◽  
2021 ◽  
Vol 14 (4) ◽  
pp. 931
Author(s):  
Karolina Mucha-Kuś ◽  
Maciej Sołtysik ◽  
Krzysztof Zamasz ◽  
Katarzyna Szczepańska-Woszczyna
Keyword(s):  
Large Scale ◽  
Local Level ◽  
Energy Transition ◽  
Building Energy ◽  
Energy Sector ◽  
The European Union ◽  
Energy Transformation ◽  
Pilot Projects ◽  
Economic Dimension ◽  
Self Sufficiency

The decentralization of the large-scale energy sector, its replacement with pro-ecological, dispersed production sources and building a citizen dimension of the energy sector are the directional objectives of the energy transformation in the European Union. Building energy self-sufficiency at a local level is possible, based on the so-called Energy Communities, which include energy clusters and energy cooperatives. Several dozen pilot projects for energy clusters have been implemented in Poland, while energy cooperatives, despite being legally sanctioned and potentially a simpler formula of operation, have not functioned in practice. This article presents the coopetitive nature of Energy Communities. The authors analysed the principles and benefits of creating Energy Communities from a regulatory and practical side. An important element of the analysis is to indicate the managerial, coopetitive nature of the strategies implemented within the Energy Communities. Their members, while operating in a competitive environment, simultaneously cooperate to achieve common benefits. On the basis of the actual data of recipients and producers, the results of simulations of benefits in the economic dimension will be presented, proving the thesis of the legitimacy of creating coopetitive structures of Energy Communities.

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