scholarly journals [18F]F-PSMA-1007 Radiolabelling without an On-Site Cyclotron: A Quality Issue

2021 ◽  
Vol 14 (7) ◽  
pp. 599
Author(s):  
Valentina Di Iorio ◽  
Stefano Boschi ◽  
Anna Sarnelli ◽  
Cristina Cuni ◽  
David Bianchini ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Radiochemical Purity ◽  
Competent Authority ◽  
Radiochemical Yield ◽  
Synthesis Process ◽  
Control Parameters ◽  
Quality Issue ◽  
Assurance System ◽  
Quality Control Parameters ◽  
Specific Membrane

Radiopharmaceuticals targeting the prostate-specific membrane antigen (PSMA) has become the gold standard for PET imaging of prostate cancer. [68Ga]Ga-PSMA-11 has been the forerunner but a [18F]F-PSMA ligand has been developed because of the intrinsic advantages of Fluorine-18. Fluorine-18 labelled compounds are usually prepared in centers with an on-site cyclotron. Since our center has not an on-site cyclotron, we decided to verify the feasibility of producing the experimental 18F-labelled radiopharmaceutical [18F]F-PSMA-1007 with [18F]F- from different external suppliers. A quality agreement has been signed with two different suppliers, and a well-established and correctly implemented quality assurance protocol has been followed. The [18F]F- was produced with cyclotrons, on Nb target, but with different beam energy and current. Extensive validation of the [18F]F-PSMA-1007 synthesis process has been performed. The aim of this paper was the description of all the quality documentation which allowed the submission and approval of the Investigational Medicinal Product Dossier (IMPD) to the Competent Authority, addressing the quality problems due to different external suppliers. The result indicates that no significant differences have been found between the [18F]F- from the two suppliers in terms of radionuclidic and radiochemical purity and [18F]F- impacted neither the radiochemical yield of the labelling reaction nor the quality control parameters of the IMP [18F]F-PSMA-1007. These results prove how a correct quality assurance system can overcome some Regulatory Authorities issue that may represent an obstacle to the clinical use of F-18-labelled radiopharmaceuticals without an on-site cyclotron

Quality and quality assurance in Chinese private higher education

2014 ◽  
Vol 22 (1) ◽  
pp. 65-87 ◽  
Author(s):  
Yingxia Cao ◽  
Xiaofan Li
Keyword(s):  
Higher Education ◽  
Quality Assurance ◽  
Private Higher Education ◽  
Three Dimensions ◽  
Quality Assurance System ◽  
Content Type ◽  
Quality Issue ◽  
Assurance System ◽  
The Government ◽  
New Framework

Purpose – The paper aims to establish a quality assurance framework for Chinese private higher education (PHE) in particular and for any newly-established higher education sector in general. Design/methodology/approach – This research relied on published qualitative and quantitative data, existing literature, historical documents, and the authors' observations. It described the PHE growth context, analyzed the quality issue from three dimensions (academic, administrative, and relationship quality), and examined its quality assurance practice through three players. Findings – The paper provides empirical insights about how quality and quality assurance issues have impacted on PHE development. To approach the issues, it suggests a “quality assurance triangle” framework that is composed of three PHE players (government, market, institution) and their joint association. Research limitations/implications – Because of the relative position of each player in current quality assurance, the success of its implementation in China depends on how the government establishes the triangle system and balances its dominating roles to ensure each of the players act independently and collaboratively. Practical implications – This framework provides directions for establishing an appropriate quality assurance system for PHE in China. Originality/value – This paper fulfills an identified need to setup a sound quality assurance system for PHE in China and contributes to quality assurance literature with a new framework.

scholarly journals On Site Production of [18F]-PSMA1007 Using Different [18F]-fluoride Activities. Practical, Technical and Economical Impact.

2021 ◽  
Author(s):  
Costantina Maisto ◽  
Anna Morisco ◽  
Roberta de Marino ◽  
Squame Elisabetta ◽  
Valentina Porfidia ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Large Scale ◽  
Radiochemical Purity ◽  
Radiochemical Yield ◽  
Good Target ◽  
Pet Ct ◽  
Fetal Bovine ◽  
Imaging Properties ◽  
Specific Membrane ◽  
Psma Inhibitor

Abstract BackgroundProstate-Specific Membrane Antigen is overexpressed in prostate cancer and it is considered a good target for staging of primary and recurrences as well as for radioligand therapy. Different PSMA-analogues have been investigated, labeled with [68Ga], showing excellent imaging properties; although, only small amounts can be produced for single synthesis. Recently, a fluorinated PSMA-inhibitor, [18F]-PSMA-1007, has been introduced, ensuring large-scale productions. In this study, the radiosynthesis of [18F]-PSMA-1007 using low (A), medium (B) and high (C) starting activities of [18F]-Fluoride, has been fully tested. The following parameters radiochemical yield, radiochemical purity and stability of [18F]-PSMA-1007 have been measured in 65, consecutive batches to verify the effects of the three different conditions. In addition, the analysis of the costs for the production has been performed. ResultsThe radiochemical yield percentage for low and medium range of activities of [18F]-Fluoride was 52%, while for the high range it decreases to 40%. The radiochemical purity was 99% in all three tested starting activities. [18F]-PSMA-1007 did not show radiolysis up to 8 hours after the end of synthesis, confirming that the radiopharmaceutical is stable an suitable for PET studies in humans. Furthermore, stability studies performed in fetal bovine serum demonstrated radiochemical stability at 37°C for 120’. ConclusionsA starting activity of [18F]-Fluoride of 90 GBq (range B) enables a final amount of [18F]-PSMA-1007 of about 50 GBq, which is powerful for different choices: to perform up to 25 PET/CT scans in a referral institution for prostate cancer, and/or to supply the eventual peripheral PET centers.

scholarly journals On site production of [18F]PSMA-1007 using different [18F]fluoride activities: practical, technical and economical impact

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Costantina Maisto ◽  
Anna Morisco ◽  
Roberta de Marino ◽  
Elisabetta Squame ◽  
Valentina Porfidia ◽  
...  
Keyword(s):  
Large Scale ◽  
Radiochemical Purity ◽  
Radiochemical Yield ◽  
Production Costs ◽  
Positron Emission ◽  
Good Target ◽  
Fetal Bovine ◽  
Imaging Properties ◽  
Specific Membrane ◽  
Psma Inhibitor

Abstract Background Prostate-specific membrane antigen is overexpressed in prostate cancer and it is considered a good target for positron emission tomography/computed tomography imaging of primary cancer and recurrent/metastatic disease, as well as for radioligand therapy. Different PSMA-analogues labeled with [68Ga]gallium have been investigated, showing excellent imaging properties; however, only small amounts can be produced for each radiolabeling. Recently, a [18F]fluoride labeled PSMA-inhibitor, [18F]PSMA-1007, has been introduced, and it has ensured large-scale productions, overcoming this limitation of [68Ga]PSMAs. In this study, PSMA-1007 has been labeled with low (A), medium (B) and high (C) starting activities of [18F]fluoride, in order to verify if radiochemical yield, radiochemical purity and stability of [18F]PSMA-1007 were affected. These parameters have been measured in sixty-five consecutive batches. In addition, the estimation of [18F]PSMA-1007 production costs is provided. Results The radiochemical yield for low and medium activities of [18F]fluoride was 52%, while for the high one it decreased to 40%. The radiochemical purity was 99% for all three activities. [18F]PSMA-1007 did not show radiolysis up to 8 h after the end of synthesis, confirming that the radiopharmaceutical is stable and suitable to perform diagnostic studies in humans for a long period of time after the end of radiolabeling. Furthermore, radiochemical stability was demonstrated in fetal bovine serum at 4 °C and 37 °C for 120′. Conclusions A starting activity of [18F]fluoride of 90 GBq (B) seems to be the best option enabling a final amount of about of 50 GBq of [18F]PSMA-1007, which is promising as it allows to: (a) perform a large number of scans, and/or (b) supply the radiopharmaceutical to any peripheral diagnostic centers in need.

Improvement of the quality assurance system for oil products to be transported by pipelines

2017 ◽  
Vol 7 (5) ◽  
pp. 88-96
Author(s):  
Sergey B. Khotnichuk ◽  
◽  
Vadim V. Bortnik ◽  
Fyodor V. Timofeev ◽  
Andrey A. Kuznetsov ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Oil Products ◽  
Quality Assurance System ◽  
Assurance System

Quality Control Parameters of Mandukarni Syrup - A classical memory enhancing dosage form

2017 ◽  
Vol 2 (4) ◽  
Author(s):  
Almas Tarannum ◽  
Prathviraj Puranik ◽  
Suma V. Mallya
Keyword(s):  
Quality Control ◽  
Refractive Index ◽  
Specific Gravity ◽  
Dosage Form ◽  
Reducing Sugar ◽  
Standard Protocol ◽  
Direct Impact ◽  
Control Parameters ◽  
Quality Control Parameters ◽  
Memory Enhancing

Ayurveda is the healing medicine. Dosha, Dhatu, Mala and Agni play important role in maintaining health of a person, but without equilibrium of Atma, Indriya and Manas they are helpless. Manas is one entity which is the controller of health. There are several herbs which have direct impact on Manas, among them Mandukaparni is one. Swarasa of Mandukaparni is highly effective, but it is not easily available for children. This study is intended to make Syrup form of Mandukaparni and evaluate its pharmacognostical parameters. According to the methodology refractive index, total solids, specific gravity, reducing and non Reducing sugar and HPTLC parameters were assessed. The results were found to be genuine fulfilling the standard protocol. This study is under taken to evaluate the pharmacognostic properties of Mandukaparni syrup.

Analytical profile of Arka Taila - An Ayurvedic oil based medicine used in Karnasrava (Otomycosis)

2017 ◽  
Vol 2 (3) ◽  
Author(s):  
Komal D. Jani ◽  
Dharmendra P. Jani
Keyword(s):  
Quality Control ◽  
Fungal Infections ◽  
Curcuma Longa ◽  
Calotropis Procera ◽  
Control Parameters ◽  
Scientific Evaluation ◽  
Quality Control Parameters ◽  
Quality Check ◽  
Based Medicine ◽  
Excessive Accumulation

Otomycosis denotes diffuse otitis externa due to fungal infections. The fungii are usually secondary invaders of the tissue rendered susceptible by bacterial infection, physical injury or excessive accumulation of cerumen in the external auditory canal. Karnasraava means discharge from ear which can be correlated with otorrhoea. Karnasraava (discharge) is one of symptom of otomycosis. Arka Taila has been mentioned in Shaarangadhara is very simple formula having ingredients i.e. Haridraa (Curcuma longa), Arka Patra Swarasa (Calotropis procera) and Sarshapa Taila (Brassica campetries). The quality control parameters resulted after scientific evaluation of Arka Taila can be used as reference standard for quality control or quality assurance of a pharmaceutical industry in order to have a proper quality check over its preparation and processing.

scholarly journals Quality Assurance Systems in Nursing. A turning point in the world of nursing homes

2014 ◽  
Vol 5 (1) ◽  
pp. 99-108
Author(s):  
Pedro Andreo ◽  
Carmelo Gómez ◽  
Elena Carrasco ◽  
Inmaculada Martínez-Escámez ◽  
Inmaculada Alguazas ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Nursing Homes ◽  
Nursing Practice ◽  
Health Indicators ◽  
General Interest ◽  
Quality Assurance System ◽  
Nursing Service ◽  
Positive Effects ◽  
Assurance System ◽  
Positive Results

Developing and trying to achieve a high quality in the service nursing personnel provide at nursing homes by means of implementing quality assurance systems is a topic of general interest nowadays. These systems have already proved to be effective in other fields. That is why the focus of this study is to analyse the most relevant effects due to the implementation of a quality assurance method based on standard UNE EN ISO 9001:2008 in the nursing service of four nursing homes. An analysis of more than 200 answers of a satisfaction survey about the nursing service at four nursing homes has been carried out. A study on the available bibliography about the results obtained after having implemented a quality assurance system in the nursing service at nursing homes has also been carried out. Very positive results can be appreciated in the daily nursing practice at nursing homes as a consequence of using a quality assurance system. Clinical practice has improved considerably as a consequence. The study shows quality assurance systems to be a useful tool at the service of nursing practice at nursing homes. Positive effects resulting from the implementation of such quality assurance systems are evident as it can be seen from satisfaction surveys and health indicators.

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