The Experts below are selected from a list of 321 Experts worldwide ranked by ideXlab platform
Patricia Williams - One of the best experts on this subject based on the ideXlab platform.
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origins practices and future of safety pharmacology
Journal of Pharmacological and Toxicological Methods, 2004Co-Authors: Ala S Ass, Lewis Kinte, Patricia WilliamsAbstract:The origins of safety pharmacology are grounded upon observations that organ functions (like organ structures) can be Toxicological targets in humans exposed to novel therapeutic agents, and that drug effects on organ functions (unlike organ structures) are not readily detected by standard Toxicological Testing. Safety pharmacology is ‘‘ ... those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relationship to exposure in the therapeutic range and above ... ’’ [International Conference on Harmonization (ICH) S7A guidelines; Safety Pharmacology Studies for Human Pharmaceuticals]. This publication provides a comprehensive review of the history of safety pharmacology, international regulatory guidelines that govern the practices of this important field, and the scientific challenges that are being faced by its rapid emergence in pharmaceutical development. The criticality of identifying undesired adverse effects of new drugs in nonclinical models, which reflect the overall human condition, is reflected in the importance of generating an integrated and accurate assessment of possible human risk. The conundrum posed by the challenge of formulating a reliable risk assessment is the importance of improving and enhancing the safe progression of new drugs to the marketplace, while preventing unnecessary delays (or discontinuances), based on nonclinical findings that are not relevant or interpretable in terms of clinical response or human risk.
Larry L. Hench - One of the best experts on this subject based on the ideXlab platform.
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Progress in Raman spectroscopy in the fields of tissue engineering, diagnostics and Toxicological Testing
Journal of Materials Science: Materials in Medicine, 2006Co-Authors: Chris A Owen, Ioan Notingher, Molly M Stevens, Robert Hill, Larry L. HenchAbstract:This review summarises progress in Raman spectroscopy and its application in diagnostics, Toxicological Testing and tissue engineering. Applications of Raman spectroscopy in cell biology are in the early stages of development, however, recent publications have demonstrated its utilisation as a diagnostic and development tool with the key advantage that investigations of living cells can be performed non-invasively.Some of the research highlighted here demonstrates the ability of Raman spectroscopy to accurately characterise cancer cells and distinguish between similar cell types. Many groups have used Raman spectroscopy to study tissues, but recently increased effort has gone into single cell analysis of cell lines; the advantages being that cell lines offer ease of handling and increased reproducibility over tissue studies and primary cells. The main goals of bio-Raman spectroscopy at this stage are twofold. Firstly, the aim is to further develop the diagnostic ability of Raman spectroscopy so it can be implemented in a clinical environment, producing accurate and rapid diagnoses. Secondly, the aim is to optimise the technique as a research tool for the non-invasive real time investigation of cell/material interactions in the fields of tissue engineering and toxicology Testing.
P K Gupta - One of the best experts on this subject based on the ideXlab platform.
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Toxicological Testing in vivo systems
Fundamentals of Toxicology#R##N#Essential Concepts and Applications, 2016Co-Authors: P K GuptaAbstract:This chapter deals with various procedures used for Toxicological Testing of new pharmaceuticals and other new chemical entities such as agrochemicals and industrial chemicals required for use in our daily lives. In some cases, basic research can produce data that eventually lead to the ban of certain chemicals because they were proven to be unsafe. This has led to increased demand for safety screening to ensure successful drug development and safe chemicals before they become available for general use. Part of this screening process includes the internationally recognized in vivo or in vitro Toxicological tests. Toxicological Testing laboratories now have to comply with strict official controls and inspections regarding animal use at any time, and they can be reinforced by relevant legislation.
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Toxicological Testing in vitro models
Fundamentals of Toxicology#R##N#Essential Concepts and Applications, 2016Co-Authors: P K GuptaAbstract:Animal welfare legislation is currently applicable in most countries to prevent misuse of animals in Toxicological Testing. The principal focus of this chapter is to highlight some of the current in vitro models available in toxicity Testing. A number of animal models that have been used for many years for screening purposes have been gradually reduced. Scientists have played an important role in the development of legislation and guidelines relating to the use and replacement of laboratory animals in toxicity assessment. The generally accepted approach to screen compounds for toxicity is to use a multitiered system, starting with simple monocultures of specific cell types, followed by co-cultures that simulate metabolic effects and/or cell–cell interactions in the whole organism, before performing final Testing on animals. Further, development of improved in vitro systems will eventually minimize the use of animals for toxicity studies.
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Toxicological Testing genesis
Fundamentals of Toxicology#R##N#Essential Concepts and Applications, 2016Co-Authors: P K GuptaAbstract:This chapter deals with tests for the safe use of chemicals. There is a wide range of laws and regulations that shape the role of toxicology in society. The purpose of implementation of these legislations is to protect the health and well-being of the people and the environment. Therefore, toxicity Testing of a chemical, for the purposes of human health risk assessment, as might be expected, is not a routine aspect of toxicology. New tests and alternate approaches are constantly being devised and are often added to Testing requirements already in existence. Most Testing can be subdivided into in vivo tests for acute, sub-chronic, or chronic effects, and in vitro tests for genotoxicity or cell transformation, although other tests are in use. Any chemical that has been developed or that is being introduced into commerce is subject to toxicity Testing using Good Laboratory Practices (GLP) guidelines to satisfy the regulatory agencies. The compounds produced as waste products of industrial processes (eg, combustion products) are also subjected to Testing.
Kit A Keller - One of the best experts on this subject based on the ideXlab platform.
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Toxicological Testing handbook
2013Co-Authors: David Jacobsonkram, Kit A KellerAbstract:Toxicological Testing handbook , Toxicological Testing handbook , کتابخانه مرکزی دانشگاه علوم پزشکی تهران
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Toxicological Testing handbook principles applications and data interpretation
2006Co-Authors: David Jacobsonkram, Kit A KellerAbstract:Regulatory Toxicology Testing: Laboratories and Good Laboratory Practices. Laboratory Animals and In Vitro Test Systems Used in Regulatory Toxicology. Metabolism and Toxicokinetics. Toxicologic Pathology Assessment. Acute Toxicology. Multidose General Toxicology Studies. Genetic Toxicology. Carcinogenicity Studies. Juvenile Animal Toxicology Studies. Developmental and Reproductive Toxicology. Neurotoxicology Testing. Toxicological Assessment of the Immune System. Inhalation and Pulmonary Toxicity Studies. Cancer Risk Assessment. Nonclinical Safety Testing of Pharmaceuticals. Health Risk Assessment Strategies in the Food and Cosmetic Industry.
James A Hutchinso - One of the best experts on this subject based on the ideXlab platform.
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in question the scientific value of preclinical safety pharmacology and toxicology studies with cell based therapies
Molecular therapy. Methods & clinical development, 2014Co-Authors: Christiane Oichhause, Paloma Riquelme, Fred Fändrich, Anja K. Wege, Norbe Ahrens, Gudru E Koehl, Hans J Schli, Ernhard Anas, Edward K Geissle, James A HutchinsoAbstract:A new cell-based medicinal product containing human regulatory macrophages, known as Mreg_UKR, has been developed and conforms to expectations of a therapeutic drug. Here, Mreg_UKR was subjected to pharmacokinetic, safety pharmacology, and Toxicological Testing, which identified no adverse reactions. These results would normally be interpreted as evidence of the probable clinical safety of Mreg_UKR; however, we contend that, owing to their uncertain biological relevance, our data do not fully support this conclusion. This leads us to question whether there is adequate scientific justification for preclinical safety Testing of similar novel cell-based medicinal products using animal models. In earlier work, two patients were treated with regulatory macrophages prior to kidney transplantation. In our opinion, the absence of acute or chronic adverse effects in these cases is the most convincing available evidence of the likely safety of Mreg_UKR in future recipients. On this basis, we consider that safety information from previous clinical investigations of related cell products should carry greater weight than preclinical data when evaluating the safety profile of novel cell-based medicinal products. By extension, we argue that omitting extensive preclinical safety studies before conducting small-scale exploratory clinical investigations of novel cell-based medicinal products data may be justifiable in some instances.
