scholarly journals Quantitative Analysis of the QMS for Pharmaceutical Manufacturing

2021 ◽  
Author(s):  
Guoxu Wang ◽  
Weibing Wang ◽  
Qiang Zheng
Keyword(s):  
Quantitative Analysis ◽  
Linear Regression ◽  
Performance Indicators ◽  
Completion Rate ◽  
Pharmaceutical Manufacturing ◽  
Statistical Methodology ◽  
Time Rate ◽  
Customer Complaints ◽  
The Right ◽  
First Time

Abstract Purpose To propose a statistical methodology for quantitative analysis of the quality management system (QMS) of pharmaceutical manufacturing. Methods (1) Based on the manufacturing data from two established active pharmaceutical ingredient (API) manufacturers in China from 2010 to 2019, the linear regression with Pearson correlation coefficient is used to find the correlations between the proposed QMS operation indicators and performance indicators. (2) A stepwise multiple linear regression is used to identify the independent operation indicators with the biggest impact on a given performance indicator. (3) The Akaike Information Criterion is used to predict the performance indicators based on the operation indicators. Results (1) Correlation: the right-first-time rate correlates strongly with various changes and deviations; the customer complaints correlate with changes, deviations, and CAPAs; the deficiency rate of foreign inspections correlates with deviations and CAPAs; and the CAPA on-time completion rate correlates with changes, deviations, and the ratio of employees in quality. (2) Impact: the right-first-time rate and the customer complaints are mostly impacted by the total deviations; the deficiency rate of foreign inspections is mostly impacted by deviations in equipment and instrument, and deviations due to human error; the CAPA on-time completion rate is mainly impacted by deviations in facility and utilities. (3) Predictability: the right-first-time rate, the customer complaints, the deficiency rate of foreign inspections, and the CAPA on-time completion rate can all be predicted based on the existing data with statistical significance. Conclusions Deviations emerge as a key leading indicator for the performance of QMS. The proposed statistical methodology provides a basis for the data-driven quality management and regulation, whose visibility and predictability are likely to progress as the data accumulates.

scholarly journals RODOLFO BENINI: ALCUNI SUOI CONTRIBUTI ALLA STATISTICA IN OCCASIONE DEI 150 ANNI DALLA NASCITA

2012 ◽  
Author(s):  
Antonietta Mira
Keyword(s):  
Social Sciences ◽  
Linear Regression ◽  
Multiple Linear Regression ◽  
Statistical Methodology ◽  
Corrado Gini ◽  
Technical Refinement ◽  
First Time

For the first time in Italy, thanks to the contributions of Rodolfo Benini, Statistics became an autonomous discipline, finally released from economical, demographical and social sciences to which was still assimilated. The rigor and the technical refinement of his analysis justify the importance attributed to his statistical contributions, and support the fact that he has been recognised by Corrado Gini as the first round Italian statistician. Starting from the interpretation by Marcello Boldrini of his «tre mirabili opere di sistemazione», I will deepen three of the main themes linked to the statistical methodology addressed by Benini: multiple linear regression, indexes of attraction and repulsion and the distribution of economical variables. I will conclude discussing his relationship with Pareto, whose law Benini first verified on income and later extended to other economical variables.

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.

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.

In the Labyrinth

2017 ◽  
Author(s):  
Andrew McNeillie
Keyword(s):  
The Right ◽  
First Time ◽  
Do So

It is now widely acknowledged, and far beyond Ireland, that Tim Robinson’s two volumes jointly known as Stones of Aran (‘Pilgrimage’ and ‘Labyrinth’) are modern classics, exemplary in every way of how to write about place and to do so with a formal, literary accomplishment that more than earns the right to nod at Ruskin’s own classic. In 2012, Robinson went back to Árainn, the largest of the three islands, for the first time in nearly ten years. He did so at the urging of Andrew McNeillie, with whom he spent two and a half days revisiting old haunts. This chapter makes account of the occasion and uses, in the process, a unique document provided by Robinson as an experiment in annotating his work. This prompts McNeillie to investigate some of his own annotations and footnotes to Aran.

scholarly journals Laparoscopic Resection of Renal Capsular Endometriosis in a Woman with Menstrual-Related Flank Pain: Case Report

2021 ◽  
Vol 27 (1) ◽  
Author(s):  
Abbas Basiri ◽  
Iman Ghanaat ◽  
Hamidreza Akbari Gilani
Keyword(s):  
Flank Pain ◽  
Pathological Examination ◽  
Histologic Evaluation ◽  
Normal Renal Parenchyma ◽  
Perinephric Space ◽  
Superior Portion ◽  
The Right ◽  
First Time ◽  
Laparoscopic Removal

Abstract Background Although involvement of the urinary system is not uncommon, endometriosis in the kidneys is rare. To date, laparoscopic partial nephrectomy has been the preferred approach for managing renal endometriosis. Here, we report for the first time the results of laparoscopic removal of a renal capsular endometriosis in a malrotated kidney in an attempt to save the whole kidney parenchyma, in terms of feasibility and safety. Case presentation A 37-year-old female presented with periodic right flank pain associated with her menstrual cycle. On imaging, a malrotated right kidney and a hypodense irregular-shaped lesion measuring 30 * 20 * 15 mm were seen in the superior portion of the right perinephric space. Histologic evaluation of the ultrasound-guided biopsy was consistent with renal capsular endometriosis. The patient underwent laparoscopic surgery to remove the capsular mass while preserving the normal renal parenchyma. Pathological examination of the biopsy obtained during surgery was in favor of renal endometriosis. At 6-month follow-up, the patient’s pain had completely disappeared and no complications had occurred. In addition, imaging did not show any remarkable recurrence. Conclusion Renal endometriosis should be strongly considered as a differential diagnosis in female patients with a renal capsular mass and exacerbation of flank pain during menstruation. Based on our experience, with preoperative needle biopsy and clearing the pathology, laparoscopic removal of the mass in spite of renal anatomic abnormality is feasible and safe and thus could be considered as a possible treatment option.

Ankle Arthritis Networking: Getting the right treatment to the right patient first time

2021 ◽  
Author(s):  
Stephen Bendall ◽  
Paul Halliwell ◽  
Andrew Goldberg ◽  
Andrew Robinson
Keyword(s):  
Ankle Arthritis ◽  
The Right ◽  
First Time

scholarly journals Determination of Flavonoids Compounds of Three Species and Different Harvesting Periods in Crataegi folium Based on LC-MS/MS

Molecules ◽  
2021 ◽  
Vol 26 (6) ◽  
pp. 1602
Author(s):  
Ya-Ping Guo ◽  
Hong Yang ◽  
Ya-Li Wang ◽  
Xiao-Xiang Chen ◽  
Ke Zhang ◽  
...  
Keyword(s):  
Quantitative Analysis ◽  
Qualitative Analysis ◽  
Quantitative Method ◽  
Total Content ◽  
Qualitative And Quantitative Analysis ◽  
Pharmacological Activities ◽  
Time Saving ◽  
Qualitative And Quantitative ◽  
First Time

Crataegi folium have been used as medicinal and food materials worldwide due to its pharmacological activities. Although the leaves of Crataegus songorica (CS), Crataegus altaica (CA) and Crataegus kansuensis (CK) have rich resources in Xinjiang, China, they can not provide insights into edible and medicinal aspects. Few reports are available on the qualitative and quantitative analysis of flavonoids compounds of their leaves. Therefore, it is necessary to develop efficient methods to determine qualitative and quantitative flavonoids compounds in leaves of CS, CA and CK. In the study, 28 unique compounds were identified in CS versus CK by qualitative analysis. The validated quantitative method was employed to determine the content of eight flavonoids of the leaves of CS, CA and CK within 6 min. The total content of eight flavonoids was 7.8–15.1 mg/g, 0.1–9.1 mg/g and 4.8–10.7 mg/g in the leaves of CS, CA and CK respectively. Besides, the best harvesting periods of the three species were from 17th to 26th September for CS, from 30th September to 15th October for CA and CK. The validated and time-saving method was successfully implemented for the analysis of the content of eight flavonoids compounds in CS, CA and CK for the first time.

Malignant Nerve Sheath Tumor of the Right Cerebral Peduncle: Case Report

Neurosurgery ◽  
2004 ◽  
Vol 54 (2) ◽  
pp. 500-504 ◽  
Author(s):  
Patrick Beauchesne ◽  
Jean-François Mosnier ◽  
Thierry Schmitt ◽  
Jacques Brunon
Keyword(s):  
Stereotactic Biopsy ◽  
Clinical Presentation ◽  
Positive Response ◽  
Cerebral Peduncle ◽  
Nerve Sheath Tumor ◽  
Chemotherapy Treatment ◽  
Nerve Sheath Tumors ◽  
Nerve Sheath ◽  
The Right ◽  
First Time

Abstract OBJECTIVE AND IMPORTANCE Schwannomas occurring in the neuraxis are very rare. Usually, these tumors are benign. Primary malignant intracerebral nerve sheath tumors are extremely rare, with only five documented cases in the international literature. We report one case of a primary malignant intracerebral nerve sheath tumor occurring in the right cerebral peduncle of a 35-year-old man. CLINICAL PRESENTATION Magnetic resonance imaging revealed a heterogeneous peripherally enhancing mass of the right cerebral peduncle, surrounded by a small edema. INTERVENTION Unlike the five cases previously reported, this is the first time a stereotactic biopsy has been performed, and this is the only patient who responded to cranial radiation therapy for approximately 2 years. When the tumor recurred, a systemic chemotherapy treatment was prescribed. No positive response was seen, and the patient died 29 months after the initial diagnosis. CONCLUSION An accurate diagnosis and planned aggressive treatment seem to be the key elements in the management of the disease.

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