Feasibility and Evaluation of Automated Methods for Radiolabeling of Radiopharmaceutical Kits with Gallium-68

2019 ◽  
Vol 12 (3) ◽  
pp. 229-237 ◽  
Author(s):  
Alban Revy ◽  
François Hallouard ◽  
Sandrine Joyeux-Klamber ◽  
Andrea Skanjeti ◽  
Catherine Rioufol ◽  
...  
Keyword(s):  
The European Union ◽  
Preparation Time ◽  
Limit Of Quantification ◽  
Manual Method ◽  
Personnel Costs ◽  
Automated Method ◽  
Gallium 68 ◽  
The Right ◽  
First Time ◽  
Automated Methods

Objective: Recent gallium-68 labeled peptides are of increasing interest in PET imaging in nuclear medicine. Somakit TOC® is a radiopharmaceutical kit registered in the European Union for the preparation of [68Ga]Ga-DOTA-TOC used for the diagnosis of neuroendocrine tumors. Development of a labeling process using a synthesizer is particularly interesting for the quality and reproducibility of the final product although only manual processes are described in the Summary of Product (SmPC) of the registered product. The aim of the present study was therefore to evaluate the feasibility and value of using an automated synthesizer for the preparation of [68Ga]Ga-DOTA-TOC according to the SmPC of the Somakit TOC®. Methods: Three methods of preparation were compared; each followed the SmPC of the Somakit TOC®. Over time, overheads, and overexposure were evaluated for each method. Results: Mean±SD preparation time was 26.2±0.3 minutes for the manual method, 28±0.5 minutes for the semi-automated, and 40.3±0.2 minutes for the automated method. Overcost of the semi-automated method is 0.25€ per preparation for consumables and from 0.58€ to 0.92€ for personnel costs according to the operator (respectively, technician or pharmacist). For the automated method, overcost is 70€ for consumables and from 4.06€ to 6.44€ for personnel. For the manual method, extremity exposure was 0.425mSv for the right finger, and 0.350mSv for the left finger; for both the semi-automated and automated method extremity exposure were below the limit of quantification. Conclusion: The present study reports for the first time both the feasibility of using a [68Ga]- radiopharmaceutical kit with a synthesizer and the limits for the development of a fully automated process.

Total and direct-reacting bilirubin values by automated methods compared with liquid chromatography and with manual methods for determining delta bilirubin

1990 ◽  
Vol 36 (5) ◽  
pp. 788-791 ◽  
Author(s):  
P Rosenthal ◽  
M T Keefe ◽  
D Henton ◽  
M Cheng ◽  
C R Lee ◽  
...  
Keyword(s):  
Liquid Chromatography ◽  
Bile Acids ◽  
Total Bilirubin ◽  
Clinical Use ◽  
Serum Samples ◽  
Manual Method ◽  
Automated Method ◽  
Manual Methods ◽  
Automated Methods ◽  
Conjugated Bilirubin

Abstract This study compares total and direct-reacting bilirubin values in 40 serum samples from patients with various diagnoses, as measured by automated methods (Beckman Synchron CX-5, Beckman Astra 8, Kodak Ektachem 700) and HPLC and by a manual method for delta bilirubin. For total bilirubin, within-run CVs were less than 6%. The Ektachem 700 method underestimated bilirubin with serum samples from patients with Crigler-Najjar syndrome and from newborns in whom unconjugated bilirubin concentrations were increased but conjugated bilirubins were not present or were present only in small amounts. The Astra 8 and Synchron CX-5 methods were inaccurate with cholestatic serum samples, in which conjugated bilirubin concentrations were increased and other compounds such as bile acids could be expected to interfere. We conclude that each automated method examined provides reasonable estimates for total and direct-reacting bilirubin values for routine clinical use. The need for each laboratory to select the appropriate bilirubin method for its particular situation is obvious.

scholarly journals Conceptualising the right to data protection in an era of Big Data

2017 ◽  
Vol 4 (1) ◽  
pp. 205395171668699 ◽  
Author(s):  
Yvonne McDermott
Keyword(s):  
Big Data ◽  
Data Protection ◽  
Legal Order ◽  
Fundamental Rights ◽  
New Right ◽  
The European Union ◽  
The Right To Privacy ◽  
Charter Of Fundamental Rights ◽  
The Right ◽  
First Time

In 2009, with the enactment of the Lisbon Treaty, the Charter of Fundamental Rights of the European Union entered into force. Under Article 8 of the Charter, for the first time, a stand-alone fundamental right to data protection was declared. The creation of this right, standing as a distinct right to the right to privacy, is undoubtedly significant, and it is unique to the European legal order, being absent from other international human rights instruments. This commentary examines the parameters of this new right to data protection, asking what are the principles underpinning the right. It argues that the right reflects some key values inherent in the European legal order, namely: privacy, transparency, autonomy and nondiscrimination. It also analyses some of the challenges in implementing this right in an era of ubiquitous veillance practices and Big Data.

scholarly journals Pojęcie współmałżonka w prawie unijnym – uwagi na tle orzeczenia w sprawie Coman (C‑673/16)

Politeja ◽  
2020 ◽  
Vol 17 (3(66)) ◽  
pp. 103-117
Author(s):  
Ewa Kamarad
Keyword(s):  
European Union ◽  
International Law ◽  
Mutual Recognition ◽  
Private International Law ◽  
Eu Law ◽  
The European Union ◽  
Court Of Justice ◽  
The Right ◽  
First Time ◽  
The Eu

The Term ‘Spouse’ in EU Law – Comments on the Judgment in the Coman Case (C‑ 673‑16) The paper concerns the judgment of 5 June 2018 issued by the Court of Justice of the European Union in the Coman case (C‑673‑16), in which the Court for the first time defined the term ‘spouse’ for the purpose of Directive 2004/38 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States. It discusses the consequences of the judgement and its relation to the traditional mechanisms of private international law and the EU principle of mutual recognition.

Case C-176/12 Association de Médiation Sociale: Some Reflections on the Horizontal Effect of the Charter and the Reach of Fundamental Employment Rights in the European Union

2014 ◽  
Vol 10 (2) ◽  
pp. 332-348 ◽  
Author(s):  
Eleni Frantziou
Keyword(s):  
European Union ◽  
Fundamental Rights ◽  
The European Union ◽  
Advocate General ◽  
Court Of Justice ◽  
Charter Of Fundamental Rights ◽  
The Right ◽  
Employment Rights ◽  
First Time ◽  
The Eu

On 15 January 2014, the Court of Justice (hereafter ‘the Court’) delivered its judgment in Association de Médiation Sociale (hereafter ‘AMS’). AMS brought for the first time before the Court the issue of horizontal applicability in relation to a provision of the EU Charter of Fundamental Rights (hereafter ‘Charter’), namely Article 27 thereof, which enshrines the right of workers to information and consultation within the undertaking. The case therefore raised questions of ‘undeniable constitutional significance’, as Advocate-General Cruz Villalón had put it in his Opinion, regarding the post-Lisbon enforcement and interpretation of the Charter and, in particular, its application to disputes between private parties.

scholarly journals Optimization of Residual Hexane in Edible Oils Analysis Using Static Headspace Gas Chromatography

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Azrul Hisyam Samsuri ◽  
May Yen Ang ◽  
Shean Yeaw Ng
Keyword(s):  
Gas Chromatography ◽  
Edible Oils ◽  
Fats And Oils ◽  
The European Union ◽  
Limit Of Quantification ◽  
Efficient Manner ◽  
Residual Hexane ◽  
Automated Method ◽  
Static Headspace Gas Chromatography ◽  
Significant Difference

This study aims to determine the residual hexane in four edible oils in Malaysia using a simple, rapid, and automated method in order to improve the efficiency and productivity of the analysis. Gas chromatography (GC/FID) equipped with a headspace autosampler (HS-20) was used to perform the analysis. Incubation time for each injection was successfully optimized from one hour to 30 minutes (50% reduction) compared to the official AOCS method Ca 3b-87. Out of the four tested edible oils, only the hexane residues detected in sunflower oil exceeded the maximum residue limit (MRL) set by the European Union regulation. Significant difference of the results obtained between large calibration range (0–938 mg kg−1) and small calibration range (0–68 mg kg−1) suggests that there is a need to use a lower standard calibration concentration to avoid misinterpretation of analysis results. Method validation applies to the technical hexane; 2-methylpentane, 3-methylpentane, cyclohexane, and methylcyclopentane, the signal-to-noise (S/N), as well as the limit of quantification (LoQ) values was found to be 218.20, 221.45, 746.37, 97.37 and 0.85, 0.84, 0.25, 1.93 mg kg−1, respectively. Good linearity, repeatability, and low carryover of this method have provided an alternative way to analyze the content of the residual hexane in edible oils in a more efficient manner. Current study might provide a fundamental reference for the improvement of the AOCS official Ca 3b-87 method for determination of hexane residues in fats and oils analysis in the future.

The right to appeal to the European Court of Human Rights

2020 ◽  
Author(s):  
Yuliya Samovich
Keyword(s):  
Human Rights ◽  
Case Law ◽  
Legal Regulation ◽  
The European Union ◽  
Educational Organizations ◽  
European Court ◽  
Protection Of Human Rights ◽  
Judicial Procedure ◽  
The Right ◽  
Judicial Protection

The manual is devoted to making individual complaints to the European Court of human rights: peculiarities of realization of the right to appeal, conditions of admissibility and the judicial procedure of the European Court of Human Rights. The author analyses some “autonomous concepts” used in the court's case law and touches upon the possibility of limiting the right to judicial protection. The article deals with the formation and development of the individual's rights to international judicial protection, as well as the protection of human rights in universal quasi-judicial international bodies and regional judicial institutions of the European Union and the Organization of American States. This publication includes a material containing an analysis of recent changes in the legal regulation of the Institute of individual complaints. The manual is recommended for students of educational organizations of higher education, studying in the areas of bachelor's and master's degree “Jurisprudence”.

Self-Regulation and Human Progress

2018 ◽  
Author(s):  
Evan Osborne
Keyword(s):  
Scientific Method ◽  
Mutual Influence ◽  
Free Market ◽  
Self Regulation ◽  
Free Expression ◽  
Trial And Error ◽  
Human History ◽  
Economic Context ◽  
The Right ◽  
First Time

Does humanity progress primarily through leaders organizing and directing followers, or through trial and error by individuals free to chart their own path? For most of human history ruling classes had the capacity and the desire to tightly regiment society, to the general detriment of progress. But beginning in the 1500s, Europeans developed a series of arguments for simply leaving well enough alone. First in the form of the scientific method, then in the form of free expression, and finally in the form of the continuously, spontaneously reordered free market, people began to accept that progress is hard, and requires that an immense number of mistakes be tolerated so that we may learn from them. This book tells the story of the development of these three ideas, and for the first time tells of the mutual influence among them. It outlines the rise, and dramatic triumph, of each of these self-regulating systems, followed by a surprising rise in skepticism, especially in the economic context. Such skepticism in the 20th century was frequently costly and sometimes catastrophic. Under the right conditions, which are more frequent than generally believed, self-regulating systems in which participants organize themselves are superior. We should accept their turbulence in exchange for the immense progress they generate.

Anti-System Politics

2020 ◽  
Author(s):  
Jonathan Hopkin
Keyword(s):  
Comparative Approach ◽  
The European Union ◽  
Political Systems ◽  
The United Kingdom ◽  
The Us ◽  
Long Term Result ◽  
The Rich ◽  
Dramatic Shift ◽  
To Come ◽  
The Right

Recent elections in the advanced Western democracies have undermined the basic foundations of political systems that had previously beaten back all challenges—from both the Left and the Right. The election of Donald Trump to the US presidency, only months after the United Kingdom voted to leave the European Union, signaled a dramatic shift in the politics of the rich democracies. This book traces the evolution of this shift and argues that it is a long-term result of abandoning the postwar model of egalitarian capitalism in the 1970s. That shift entailed weakening the democratic process in favor of an opaque, technocratic form of governance that allows voters little opportunity to influence policy. With the financial crisis of the late 2000s, these arrangements became unsustainable, as incumbent politicians were unable to provide solutions to economic hardship. Electorates demanded change, and it had to come from outside the system. Using a comparative approach, the text explains why different kinds of anti-system politics emerge in different countries and how political and economic factors impact the degree of electoral instability that emerges. Finally, it discusses the implications of these changes, arguing that the only way for mainstream political forces to survive is for them to embrace a more activist role for government in protecting societies from economic turbulence.

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