Nonclinical Immunotoxicity Testing in the Pharmaceutical World: The Past, Present, and Future

2019 ◽  
pp. 216847901986455
Author(s):  
Paul Baldrick

An examination for potential direct or indirect adverse effects on the immune system (immunotoxicity) is an established component of nonclinical testing to support safe use of new drugs. Testing recommendations occur in various regulatory guidance documents, especially ICH S8, and these will be presented. Key evaluation usually occurs in toxicology studies with further investigative work a consideration if a positive signal is seen. Expectations around whether findings may occur are related to the type of compound being developed, including a chemically synthesized small molecule, a small molecule oncology drug, a biopharmaceutical, an oligonucleotide, a gene therapy/stem cell product, a vaccine, or reformulation of drugs in liposomes or depots. Examples of immunotoxicity/immunogenicity findings will be discussed for all of these types of compound. Overall, it can be concluded that our main tool for evaluation of potential immunotoxicity/immunogenicity for a new drug still remains standard toxicology study testing with key assessment for effects on clinical pathology and lymphoid organs/tissues (weights and cellularity). Additional evaluation from studies using a T cell–dependent antibody response (TDAR) and lymphocyte phenotyping is also valuable, if needed. Thus, using the tools from the past, it is the role of toxicologists to work with clinical teams now and in the future, to interpret findings from nonclinical testing to possible adverse findings in humans.

Author(s):  
Benjamin F. Trump ◽  
Irene K. Berezesky ◽  
Raymond T. Jones

The role of electron microscopy and associated techniques is assured in diagnostic pathology. At the present time, most of the progress has been made on tissues examined by transmission electron microscopy (TEM) and correlated with light microscopy (LM) and by cytochemistry using both plastic and paraffin-embedded materials. As mentioned elsewhere in this symposium, this has revolutionized many fields of pathology including diagnostic, anatomic and clinical pathology. It began with the kidney; however, it has now been extended to most other organ systems and to tumor diagnosis in general. The results of the past few years tend to indicate the future directions and needs of this expanding field. Now, in addition to routine EM, pathologists have access to the many newly developed methods and instruments mentioned below which should aid considerably not only in diagnostic pathology but in investigative pathology as well.


Author(s):  
Nasser Fathi Easa ◽  
Ayman Mahmoud Bazzi

This paper aims to review the literature over the past 10 years related to employer branding by shedding light on its role of enhancing employer attractiveness, employee engagement, and retention. The paper offers a better understanding for the literature gap related to the employer branding field. A systematic review of 33 articles published between 2010 and 2019 was conducted in which the reviewed papers were classified depending on electronic databases, namely Emerald, Science Direct, and Business Source Complete. The research findings were analyzed based on two classifications: descriptive and main topic analysis. The majority of the reviewed articles were empirical studies published during the year 2018, revealing the importance of employer branding by creating employer attractiveness, employee engagement, and employee retention, in addition to focusing on employee retention as a main tool for achieving a competitive advantage.


2020 ◽  
Author(s):  
Gabriel dos Passos Gomes ◽  
Robert Pollice ◽  
Alan Aspuru-Guzik

<div><div><div><p>The ability to forge difficult chemical bonds through catalysis has transformed society on all fronts, from feeding our ever-growing populations to increasing our life-expectancies through the synthesis of new drugs. However, developing new chemical reactions and catalytic systems is a tedious task that requires tremendous discovery and optimization efforts. Over the past decade, advances in machine learning have revolutionized a whole new way to approach data- intensive problems, and many of these developments have started to enter chemistry. However, similar progress in the field of homogenous catalysis are only in their infancy. In this article, we want to outline our vision for the future of catalyst design and the role of machine learning to navigate this maze.</p></div></div></div>


2020 ◽  
Author(s):  
Gabriel dos Passos Gomes ◽  
Robert Pollice ◽  
Alan Aspuru-Guzik

<div><div><div><p>The ability to forge difficult chemical bonds through catalysis has transformed society on all fronts, from feeding our ever-growing populations to increasing our life-expectancies through the synthesis of new drugs. However, developing new chemical reactions and catalytic systems is a tedious task that requires tremendous discovery and optimization efforts. Over the past decade, advances in machine learning have revolutionized a whole new way to approach data- intensive problems, and many of these developments have started to enter chemistry. However, similar progress in the field of homogenous catalysis are only in their infancy. In this article, we want to outline our vision for the future of catalyst design and the role of machine learning to navigate this maze.</p></div></div></div>


2021 ◽  
Vol 22 (19) ◽  
pp. 10808
Author(s):  
Elena G. Varlamova ◽  
Egor A. Turovsky ◽  
Ekaterina V. Blinova

This review presents the latest data on the importance of selenium nanoparticles in human health, their use in medicine, and the main known methods of their production by various methods. In recent years, a multifaceted study of nanoscale complexes in medicine, including selenium nanoparticles, has become very important in view of a number of positive features that make it possible to create new drugs based on them or significantly improve the properties of existing drugs. It is known that selenium is an essential trace element that is part of key antioxidant enzymes. In mammals, there are 25 selenoproteins, in which selenium is a key component of the active site. The important role of selenium in human health has been repeatedly proven by several hundred works in the past few decades; in recent years, the study of selenium nanocomplexes has become the focus of researchers. A large amount of accumulated data requires generalization and systematization in order to improve understanding of the key mechanisms and prospects for the use of selenium nanoparticles in medicine, which is the purpose of this review.


2015 ◽  
Vol 5 (1) ◽  
pp. 218
Author(s):  
Wiwik Setiyani

<p>The article scrutinizes the role of the actor of Tlasih 87 community in coping with social problems and his efforts to create harmony and peace among interreligious adherents in Sumbergirang village of Mojokerto East Java. The writer puts emphasis on the discussion about the methods employed by the actor to achieve his goals. In addition, the form of teaching proposed by the actor to Sumbergirang society will be another focus of the discussion. The writer finds that humanist approach has become the main tool used by the actor of Tlasih 87 in dealing with social problems. Such approach has brought about success to help the marginalized people in Sumbergirang. Regarding the teaching promulgated by the actor of Tlasih 87, the writer argues that this is a sort of cultural and religious syncretism between Javanese and Balinese culture as well as religious teachings of Islam and Hinduism along with <em>kejawen</em>. Although this teaching has encountered challenges during its dissemination, the number of the followers of Tlasih 87 have significantly increased. Tlasih 87 has widely spread out of Sumbergirang in a number of regions in East Java such as Gresik and Surabaya. The main spirit held by the actor of Tlasih 87 is building harmony and creating peace towards the unity of interreligious adherents as well as preserving culture inherited from the past generations.</p>


2019 ◽  
pp. 121-143
Author(s):  
Riccardo Resciniti ◽  
Federica De Vanna

The rise of e-commerce has brought considerable changes to the relationship between firms and consumers, especially within international business. Hence, understanding the use of such means for entering foreign markets has become critical for companies. However, the research on this issue is new and so it is important to evaluate what has been studied in the past. In this study, we conduct a systematic review of e-commerce and internationalisation studies to explicate how firms use e-commerce to enter new markets and to export. The studies are classified by theories and methods used in the literature. Moreover, we draw upon the internationalisation decision process (antecedents-modalities-consequences) to propose an integrative framework for understanding the role of e-commerce in internationalisation


2020 ◽  
Vol 28 (1) ◽  
pp. 106-121
Author(s):  
Kato Gogo Kingston

Financial crime in Nigeria – including money laundering – is ravaging Nigeria's economic growth. In the past few years, the Nigerian government has made efforts to tackle money laundering by enacting laws and setting up several agencies to enforce the laws. However, there are substantial loopholes in the regulatory and enforcement regimes. This article seeks to unravel the involvement of the churches as key drivers in money laundering crimes in Nigeria. It concludes that the permissive secrecy which enables churches to conceal the names of their financiers and donors breeds criminality on an unimaginable scale.


2020 ◽  
Vol 28 (2) ◽  
pp. 298-318
Author(s):  
Roman Girma Teshome

The effectiveness of human rights adjudicative procedures partly, if not most importantly, hinges upon the adequacy of the remedies they grant and the implementation of those remedies. This assertion also holds water with regard to the international and regional monitoring bodies established to receive individual complaints related to economic, social and cultural rights (hereinafter ‘ESC rights’ or ‘socio-economic rights’). Remedies can serve two major functions: they are meant, first, to rectify the pecuniary and non-pecuniary damage sustained by the particular victim, and second, to resolve systematic problems existing in the state machinery in order to ensure the non-repetition of the act. Hence, the role of remedies is not confined to correcting the past but also shaping the future by providing reforming measures a state has to undertake. The adequacy of remedies awarded by international and regional human rights bodies is also assessed based on these two benchmarks. The present article examines these issues in relation to individual complaint procedures that deal with the violation of ESC rights, with particular reference to the case laws of the three jurisdictions selected for this work, i.e. the United Nations, Inter-American and African Human Rights Systems.


Somatechnics ◽  
2017 ◽  
Vol 7 (2) ◽  
pp. 288-303
Author(s):  
Michael Connors Jackman

This article investigates the ways in which the work of The Body Politic (TBP), the first major lesbian and gay newspaper in Canada, comes to be commemorated in queer publics and how it figures in the memories of those who were involved in producing the paper. In revisiting a critical point in the history of TBP from 1985 when controversy erupted over race and racism within the editorial collective, this discussion considers the role of memory in the reproduction of whiteness and in the rupture of standard narratives about the past. As the controversy continues to haunt contemporary queer activism in Canada, the productive work of memory must be considered an essential aspect of how, when and for what reasons the work of TBP comes to be commemorated. By revisiting the events of 1985 and by sifting through interviews with individuals who contributed to the work of TBP, this article complicates the narrative of TBP as a bluntly racist endeavour whilst questioning the white privilege and racially-charged demands that undergird its commemoration. The work of producing and preserving queer history is a vital means of challenging the intentional and strategic erasure of queer existence, but those who engage in such efforts must remain attentive to the unequal terrain of social relations within which remembering forms its objects.


Sign in / Sign up

Export Citation Format

Share Document