Clinical Evaluation of New Drugs

PEDIATRICS ◽  
1959 ◽  
Vol 24 (5) ◽  
pp. 733-733

This book is a collection of essays by authors of established repute. The essays outline the general principles and important points to be kept in mind in the evaluation of drugs. The contents cover a wide range of topics from statistics to ethics. The objective of the series of essays is to improve the calibre of clinical trials in order to define the potentials of new drugs more accurately and rapidly, and also to present standards which should enable the practitioner and student to be more critical in judging the reports of clinical trials and the claims which are made in the promotion of new drugs. The book will probably be most useful in furnishing an introduction to the subject.

2019 ◽  
Vol 8 (4) ◽  
pp. 12-18
Author(s):  
T. M. Alekseeva ◽  
T. R. Stuchevskaya ◽  
V. S. Demeshonok

Amyotrophic lateral sclerosis is a neurodegenerative disease, resulting in the loss of self-service and death of the middle-aged and elderly people. In the last 2 decades, significant progress has been made in the study of the pathogenesis of this disease. Two known drugs (riluzole and edaravone) have been approved by the Food and Drug Administration for treatment of amyotrophic lateral sclerosis. The efficacy of these drugs is extremely low, so clinical trials of new drugs are ongoing all over the world. This review discusses the current achievements and future directions of therapy of this disease.


1950 ◽  
Vol 2 (3) ◽  
pp. 124-131 ◽  
Author(s):  
R. G. Hopkinson

A technique is described by which, the quantitative connection between physical aspects of a stimulus situation and subjective aspects of the perceptual response may be conveniently and reliably determined. The subject is given control of one of the significant physical variables such, for instance, as brightness, and is asked to set this variable to correspond In turn with a limited number of defined criteria relating to a subjective variable such as glare-discomfort It is found that each criterion acts as a check upon judgments made in terms of the others, so that the scatter of the control settings Is less than when a single criterion is used The functional relationship between the physical and the subjective variable can be estimated, and provided care Is taken in the design of the experiment and In the selection of observers, consistent results are obtained. This technique has been applied during the past ten years to a wide range of visual problems which Include those of the visibility of radar echoes, the visibility of street-lighting from the air, discomfort-glare and ease of reading. It Is thought that It might find wide application not only in applied Psychological work but in the investigation of problems of theoretical import.


2020 ◽  
Vol 5 (10) ◽  
pp. 122-139
Author(s):  
Katia Mazzucco

There is no evidence of a consistent theoretical position of Aby Warburg regarding photography, but his scattered notes on the subject allow for a deductive evaluation. The considerable use of photographs that he made in his work suggests a wide range of methodological approaches, with significant implications for the disciplinary and methodological definition of art history and the development of photographic documentation at the turn of the 20th century. This essay provides examples of Warburg’s early attention to photography, both as a research tool and a required piece of equipment for any research institute.


2019 ◽  
Vol 1 (1) ◽  
pp. 456-463
Author(s):  
Andrzej Pacana ◽  
Dominika Siwiec

Abstract The analyses of the nonconformity of products are made in order to achieve the desired level of their quality. This is also the case in the analyzed enterprise located in south-eastern Poland. Due to production character in this enterprise to identify the incompatibilities of products the non-destructive tests are used. In the current approach to quality after identified the nonconformities the cause her arise were determined, it was noted in order to use by statistical analyzes. Unfortunately, no deeper qualitative analyzes were made which could specify the source of its creation. Therefore, it was considered that it is necessary to propose to use (near current actions according to non-destructive tests) the sequence of quality management instruments. In order to improve the quality control actions, the sequence of techniques which complement each other, i.e. non-destructive tests, Ishikawa diagram and 5Why method, was proposed. To demonstrate the effectiveness of the proposed sequence, the rear cover of the bearing turbine was selected as the subject of the analysis. The choice was conditioned by the unit character of production, which till now was discouraged a detailed analysis of sources of nonconformities. After analyzed the product with used the fluorescent method the nonconformities were identified on the rear cover of the bearing turbine, which was the porosity cluster. In order to identify the causes these nonconformities the Ishikawa diagram was drawn up. Next, the selected main causes (i.e. supplier of the product and nonconformities created during the production of the product) were analyzed the 5Why method in order to identify the source cause of the problem. In this case, it was the nonconformity material from the supplier. The proposed sequence, which uses the minimal resources let to show the wide range of information, which should be used to the improvement of quality. The presented the set of activities can be practised in each of the enterprises to analyze quality problems in order to identify the nonconformities and their causes.


2021 ◽  
Vol 18 (1) ◽  
pp. 44-54
Author(s):  
Liliya I. Sattarova

The article deals with a little-known mo- nument of Seljuk woodcarving — a door from an ancient Friday mosque (Jami-i Kebir) in Kayseri (Turkey). The carved door, exhibited now in the Ankara Museum of Ethnography, has not yet been the subject of a comprehensive publication. Therefore, this artifact belongs to the group of Anatolian Seljuk woodcarvings, made in the 12th — early 13th centuries, that have a special significance. As rare monuments of Islamic art of the pre-Mongol Middle East, they stood at the origins of the blooming of Anatolian Seljuk art that would occur some decades later.The door was ordered and installed during the Jami-i Kebir mosque renovation, carried out in the second reign of the Seljuk Sultan Giyseddin I Kayhosrov (1205—1211), on the instructions of one of his emirs — Muzaffar al-din Mahmud son of Yagy-Basan, a descendant of the Danishmendid dynasty. The article considers the door’s ornamental decoration, organized as a classic “mihrab” composition, in a set of technical and stylistic aspects. For a comparative analysis, the author inspects a wide range of woodcarvings of the 11th—13th centuries from Anatolia and Iran. The close resemblance of used techniques and decoration, as well as motifs, ornamental themes and epigraphy makes it possible to suggest that the cabinet maker Ibrahim son of Abu-Bakr al-Rumi, who left his signature on the Minbar of the Alaaddin Mosque in Ankara Fortress, could be the author of the magnificent carved door from Kayseri’ Jami-i Kebir.


2005 ◽  
Vol 56 (7) ◽  
pp. 645 ◽  
Author(s):  
G. B. Taylor

Hardseededness (seed coat impermeability) is the main seed dormancy mechanism for regulating germination of annual pasture legumes both within and between years. Progress made in Australia over the past 30 years towards an understanding and better utilisation of the mechanism is the subject of this review, together with relevant overseas studies. Although some legumes produce virtually no hard seeds, newly ripened seeds of most cultivated annual pasture legumes are >90% hard when produced under favourable seed maturation conditions. The pattern of seed softening (loss of impermeability) varies widely among legumes both within and between years and is one of the more important considerations in selection programs. The many factors that influence the longevity of seed hardness are described. Differences among legumes in patterns of summer and autumn seed softening, which may influence the extent of seed losses through false breaks of season, are explained in terms of a 2-stage conceptual model of the seed softening process. This model has led to the development of laboratory techniques that effectively simulate field softening behaviour in a wide range of legumes. Different rates of seed imbibition, which may be attributable to a previously unrecognised stage in the seed softening process, and which can offer some further protection against false breaks of season are also described. The wide range of seed softening characteristics that are now recognised provides opportunities for better adapting pasture legumes to particular management systems, including rotations with crops.


Energies ◽  
2021 ◽  
Vol 14 (24) ◽  
pp. 8214
Author(s):  
Leszek Piechowski ◽  
Adam Muc ◽  
Jan Iwaszkiewicz

The article presents an active bridge system that enables the solution of a significant problem consisting in ensuring correct indications of temperature values in a wide measuring range for a Pt100 temperature sensor with properties defined by the standard (EN-60751 + A2). The presented active bridge system combines the properties of the measuring amplifier with the stabilization of the current value in the branch in which the Pt100 sensor was placed. The article focuses on the comparison of the temperature measurement in a typical resistance bridge and the measurement made in the developed active bridge, which has also become the subject of a patent. For the performed tests, in which the correctness of the temperature measurement system operation was verified, and on the basis of the obtained results, the quality of temperature measurements was compared in a wide range of changes.


ANALES RANM ◽  
2021 ◽  
Vol 138 (138(01)) ◽  
pp. 44-51
Author(s):  
Juan Tamargo

Heart failure (HF) represents an important healthcare problem due to its high prevalence, high rates of hospitalization and mortality, and significant healthcare costs. HF comprises a heterogeneous group of syndromes with different pathophysiology, clinical presentation, and response to treatment. In recent years, multiple therapeutic targets implicated in the pathogenesis of HF have been identified and numerous drugs have been developed against multiple targets. But despite important advances in the pharmacological treatment of HF with reduced ejection fraction, no treatment has convincingly shown to date to reduce mortality in HF patients with preserved ejection fraction. Furthermore, the vast majority of drugs that appeared very promising in animal models or in phase 2 clinical trials have not been able to be commercialized due to their lack of efficacy and / or safety in large phase 3 clinical trials. In this article we analyze the objectives of the treatment of HF, the progress made in recent years and the possible causes that could explain our repeated failures.


1986 ◽  
Vol 10 (3) ◽  
pp. 142-148 ◽  
Author(s):  
J. M. Holden ◽  
G. R. Fernie

This study served as a pilot to develop the methodology for a larger number of clinical trials. Ten trans-tibial amputees compared sockets made by conventional methods with sockets made using computer aided socket design (CASD). Prosthetists, paired for experience, fitted each subject with one prosthesis using each method. A preferred socket was selected by the subject on the basis of comfort without knowledge of the method by which the socket was designed. Prosthetists also evaluated the sockets. Three subjects preferred sockets built using CASD and one subject preferred the conventional socket only slightly more than the CASD socket. Six subjects clearly preferred the conventional fitting.


Vaccines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 557
Author(s):  
Anabel Torrente-López ◽  
Jesús Hermosilla ◽  
Natalia Navas ◽  
Luis Cuadros-Rodríguez ◽  
José Cabeza ◽  
...  

Major efforts have been made in the search for effective treatments since the outbreak of the COVID-19 infection in December 2019. Extensive research has been conducted on drugs that are already available and new treatments are also under development. Within this context, therapeutic monoclonal antibodies (mAbs) have been the subject of widespread investigation focusing on two target-based groups, i.e., non-SARS-CoV-2 specific mAbs, that target immune system responses, and SARS-CoV-2 specific mAbs, designed to neutralize the virus protein structure. Here we review the latest literature about the use of mAbs in order to describe the state of the art of the clinical trials and the benefits of using these biotherapeutics in the treatment of COVID-19. The clinical trials considered in the present review include both observational and randomized studies. We begin by presenting the studies conducted using non-SARS-CoV-2 specific mAbs for treating different immune disorders that were already on the market. Within this group of mAbs, we focus particularly on anti-IL-6/IL-6R. This is followed by a discussion of the studies on SARS-CoV-2 specific mAbs. Our findings indicate that SARS-CoV-2 specific mAbs are significantly more effective than non-specific ones.


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