Download or read book Guidance Document on Good In Vitro Method Practices GIVIMP written by Organisation for Economic Co-operation and Development and published by . This book was released on 2018 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which data are generated must adhere to defined standards to ensure resulting data are rigorous and reproducible. Good In vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment aims to help reduce the uncertainties in cell and tissue-based in vitro method derived chemical safety predictions. GIVIMP provides guidance for test method developers and end users of resulting data on key elementes of in vitro methods. GIVIMP tackles ten important aspects related to in vitro work: (1) Roles and responsibilities, (2) Quality considerations, (3) Facilities (4) Apparatus, material and reagents, (5) Test systems, (6) Test and reference/control items, (7) Standard operating procedures (SOPs), (8) Performance of the method, (9) Reporting of results, (10) Storage and retention of records and materials.

Download or read book Guidance Document on Good In Vitro Method Practices GIVIMP written by Organisation for Economic Co-operation and Development and published by . This book was released on 2018 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which data are generated must adhere to defined standards to ensure resulting data are rigorous and reproducible. Good In vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment aims to help reduce the uncertainties in cell and tissue-based in vitro method derived chemical safety predictions. GIVIMP provides guidance for test method developers and end users of resulting data on key elementes of in vitro methods. GIVIMP tackles ten important aspects related to in vitro work: (1) Roles and responsibilities, (2) Quality considerations, (3) Facilities (4) Apparatus, material and reagents, (5) Test systems, (6) Test and reference/control items, (7) Standard operating procedures (SOPs), (8) Performance of the method, (9) Reporting of results, (10) Storage and retention of records and materials.

Download or read book OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices GIVIMP written by OECD and published by OECD Publishing. This book was released on 2018-12-10 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...

Download or read book OECD Guidelines for the Testing of Chemicals Section 4 Test No 442E In Vitro Skin Sensitisation In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation written by OECD and published by OECD Publishing. This book was released on 2024-06-25 with total page 91 pages. Available in PDF, EPUB and Kindle. Book excerpt: The present Key Event based Test Guideline (TG) addresses the human health hazard endpoint skin sensitisation, following exposure to a test chemical. Skin sensitisation refers to an allergic response following skin contact with the tested chemical, as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). This TG is proposed to address the activation of dendritic cells, which is one Key Event on the Adverse Outcome Pathway (AOP) for Skin Sensitisation. It provides four in vitro test methods addressing the same Key Event on the AOP: (i) the human cell Line Activation Test or h-CLAT method, (ii) the U937 Cell Line Activation Test or U-SENS, (iii) the Interleukin-8 Reporter Gene Assay or IL-8 Luc assay and (iv) the Genomic Allergen Rapid Detection for assessment of skin sensitisers (GARDTMskin). All of them are used for supporting the discrimination between skin sensitisers and non-sensitisers in accordance with the UN GHS. The test methods described in this TG either quantify the change in the expression of cell surface marker(s) CD54 and CD86, the cytokine IL-8, or a series of genes (genomic biomarker signature) that are associated with the process of activation of monocytes and DC following exposure to sensitisers.

Download or read book OECD Series on Testing and Assessment Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption written by OECD and published by OECD Publishing. This book was released on 2018-09-03 with total page 692 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals.

Download or read book Human Organs on a Chip written by Javier Ramón-Azcón and published by Elsevier. This book was released on 2023-11-15 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Human Organs-on-Chip: Novel Organ-on-a-Chip Techniques in Medicine paves the way for novel approaches that push forward in-vitro and in-vivo studies and fills a gap between laboratory and clinical use. These experienced authors share the knowledge they’ve developed with over a decade of experience and research with organ-on-chips and multi-organ-on-chips. This book collects all of the developments in the field and sheds new light on possibilities to develop human on-chip measurement methods with the utilization of currently available measurement techniques including both invasive and non-invasive tests. Human Organs-on-Chip: Novel Organ-on-a-Chip Techniques in Medicine serves as a starting point for young researchers who are beginning their scientific journeys. Provides an overview of the progress suborgan-on-chips development has made in recent years Introduces the fundamentals needed to understand lab-on-chip ideas with references and in-depth explanations Presents commercial achievements obtained and future perspectives

Download or read book Practical Handbook on the 3Rs in the Context of the Directive 2010 63 EU written by Gianni Dal Negro and published by Academic Press. This book was released on 2021-11-18 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU provides updated information on the EU Directive 2010/63/EU, which is the European Union legislation that protects animals being used in research. EU Directive 2010/63/EU is the European Union (EU) legislation 'on the protection of animals used for scientific purposes' and is one of the most stringent ethical and welfare standards worldwide. Closes a gap in scientific literature by addressing the need for clear guidance in walking through the multifaced universe of 3Rs Offers a useful starting point for readers and scientist who approach the 3Rs for the first-time Gives insights into the harmonization of the animal research legislation across countries

Download or read book Organotypic Models in Drug Development written by Monika Schäfer-Korting and published by Springer Nature. This book was released on 2021-03-25 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides latest findings in organotypic models in drug development and provides the scientific resonance needed in an emerging field of research in disciplines, such as molecular medicine, physiology, and pathophysiology. Today the research on human-based test systems has gained major interest and funding in the EU and the US has increased over the last years. Moreover, so-called 3R (reduce, replace, refine animal experiments) centres have been established worldwide.

Download or read book OECD Guidelines for the Testing of Chemicals Section 4 Test No 458 Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals written by OECD and published by OECD Publishing. This book was released on 2023-07-04 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Test Guideline describes in vitro assays, which use Androgen Receptor TransActivation (ARTA) to detect Androgen Receptor Agonists and Antagonists. The ARTA assay methods are mechanistically and functionally similar test methods that provide information on the transcription and translation of a reporter gene following the binding of a chemical to the androgen receptor and subsequent transactivation.

Download or read book Environmental Toxicology written by Luis M Botana and published by Walter de Gruyter GmbH & Co KG. This book was released on 2024-03-18 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book about Non-bacterial toxins will cover those toxins that affect food safety and are produced by fungi (mycotoxins), cyanobacteria (cyanotoxins) and marine microalgae (phycotoxins). These three group of toxins affect food safety and drinking water quality at a global scale, and they pose three main challenges for scientists: 1) Climate change is causing a slow but steady change on the chemical profile of each of these groups, causing intoxications in areas that are geographically new to the intoxications map. For this reason, emerging toxins are a new topic that requires an important reallocation of resources to understand the new toxins trends, their toxicology, their analytical control and how to deal with them from a regulatory standpoint. 2) Toxicological science needs to be updated to determine the impact of the toxins in all kind of vectors (more and more are being discovered) and how they disseminate on the food chain. Also, the mode of action of many of this toxins is not understood or even known, and this affects also to the impact of the coexistence of several toxins in the same matrix. 3) Detection and regulation, as this requires the use of advance technology (mass spectrometry, biosensors, multitask screening etc) that is in many cases underdevelopped or not available, especially for many of the new toxins. Climate change, toxicology and detection affect so many areas of science that this book will try to keep the readers updated about the current state of the art.

Download or read book OECD Guidelines for the Testing of Chemicals Section 4 Test No 494 Vitrigel Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage written by OECD and published by OECD Publishing. This book was released on 2021-06-17 with total page 22 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Vitrigel-Eye Irritancy Test (EIT) method is an in vitro test method that allows the identification of test chemicals not requiring classification and labelling for eye irritation or serious eye damage. This test measures the eye irritation potential of a test chemical based on its ability to induce damage to the barrier function of the human corneal epithelium (hCE) models used in the Vitrigel-EIT method. It is known that chemicals that are irritating to the eye first destroy tear film and epithelial barrier function of the eye, subsequently induce epithelial cell death, and finally produce stromal degeneration and endothelial cell death, resulting in corneal opacity. Therefore, the change of the epithelial barrier function is a relevant endpoint for detecting eye irritation. In the Vitrigel Eye Irritancy test method , time-dependent changes in the Transepithelial Electrical Resistance (TEER) values are indicative of damage to the barrier function of the corneal epithelium following exposure to a test chemical; this situation is similar to the observed damage of the rabbit cornea following exposure to a test chemical, which is an important mode of action leading to damage of the corneal epithelium and eye irritation. The Vitrigel-Eye Irritancy Test (EIT) method can be used within the limited applicability domain of test chemicals having pH > 5.0 (based on 2.5% weight/volume (w/v) preparation).

Download or read book OECD Guidelines for the Testing of Chemicals Section 4 Test No 432 In Vitro 3T3 NRU Phototoxicity Test written by OECD and published by OECD Publishing. This book was released on 2004-11-23 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Test Guideline describes a method to evaluate photo-cytotoxicity by the relative reduction in viability of cells exposed to the chemical in the presence versus absence of light. Balb/c 3T3 cells are maintained in culture for 24 h for formation ...

Download or read book Freshney s Culture of Animal Cells written by R. Ian Freshney and published by John Wiley & Sons. This book was released on 2021-02-17 with total page 832 pages. Available in PDF, EPUB and Kindle. Book excerpt: FRESHNEY’S CULTURE OF ANIMAL CELLS THE NEW EDITION OF THE LEADING TEXT ON THE BASIC METHODOLOGY OF CELL CULTURE, FULLY UPDATED TO REFLECT NEW APPLICATIONS INCLUDING IPSCS, CRISPR, AND ORGAN-ON-CHIP TECHNOLOGIES Freshney’s Culture of Animal Cells is the most comprehensive and up-to-date resource on the principles, techniques, equipment, and applications in the field of cell and tissue culture. Explaining both how to do tissue culture and why a technique is done in a particular way, this classic text covers the biology of cultured cells, how to select media and substrates, regulatory requirements, laboratory protocols, aseptic technique, experimental manipulation of animal cells, and much more. The eighth edition contains extensively revised material that reflects the latest techniques and emerging applications in cell culture, such as the use of CRISPR/Cas9 for gene editing and the adoption of chemically defined conditions for stem cell culture. A brand-new chapter examines the origin and evolution of cell lines, joined by a dedicated chapter on irreproducible research, its causes, and the importance of reproducibility and good cell culture practice. Throughout the book, updated chapters and protocols cover topics including live-cell imaging, 3D culture, scale-up and automation, microfluidics, high-throughput screening, and toxicity testing. This landmark text: Provides comprehensive single-volume coverage of basic skills and protocols, specialized techniques and applications, and new and emerging developments in the field Covers every essential area of animal cell culture, including lab design, disaster and contingency planning, safety, bioethics, media preparation, primary culture, mycoplasma and authentication testing, cell line characterization and cryopreservation, training, and troubleshooting Features a wealth of new content including protocols for gene delivery, iPSC generation and culture, and tumor spheroid formation Includes an updated and expanded companion website containing figures, artwork, and supplementary protocols to download and print The eighth edition of Freshney’s Culture of Animal Cells is an indispensable volume for anyone involved in the field, including undergraduate and graduate students, clinical and biopharmaceutical researchers, bioengineers, academic research scientists, and managers, technicians, and trainees working in cell biology, molecular biology, and genetics laboratories.

Download or read book Stem Cells Heterogeneity Novel Concepts written by Alexander Birbrair and published by Springer. This book was released on 2019-04-23 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a comprehensive discussion on the novel concepts in stem cell heterogeneity, from pluripotent stem cells to human mesenchymal stem cells, adult and cancer stem cells of the thyroid, sarcoma, and more. Thus, Stem Cell Heterogeneity - Novel Concepts starts from a timely update on the current information on stem cells heterogeneity in various tissues and discusses new concepts and future directions. It also provides a solid foundation of the history of stem cells from specific tissues and the current applications of this knowledge in regenerative medicine. When taken as a whole, alongside its companion volumes Stem Cells Heterogeneity in Different Organs, and Stem Cells Heterogeneity in Cancer, these three books present a comprehensive reference on stem cell heterogeneity in various tissues and current and future applications for regenerative medicine. It is essential reading for advanced cell biology students as well as researchers in stem cells and clinicians.

Download or read book Molecular Biology and Biotechnology written by Ralph Rapley and published by Royal Society of Chemistry. This book was released on 2021-05-17 with total page 549 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in molecular biology and biotechnology are increasing at a rapid pace, both in the development of new methodologies and in their practical applications. This popular textbook has been revised and updated to provide an overview of this exciting area of bioscience and to reflect a number of the key developments driving this expansion. Chapters on the basic methods of key technologies such as nucleic acid analysis and bioinformatics are presented, in addition to genomics and proteomics, which highlight the impact of molecular biology and biotechnology. New chapters on important and emerging methods have been introduced such as gene editing, next generation sequencing, nanobiotechnology and molecular modelling. The first six chapters deal with the core technology used in current molecular biology and biotechnology. These primarily deal with basic molecular biology methods such as PCR, cloning genes and genomes, protein analysis techniques and recombinant protein production. Later chapters address major advances in the applications of specialist areas of molecular biotechnology. Experienced lecturers and researchers have written each chapter and the information is presented in an easily assimilated form. This book makes an ideal text for undergraduates studying these areas and will be of particular interest to students in many areas of biosciences, biology and chemistry. In addition, it will appeal to postgraduates and other scientific workers who need a sound introduction to this ever rapidly advancing and expanding area.

Download or read book OECD Guidelines for the Testing of Chemicals Section 2 Test No 249 Fish Cell Line Acute Toxicity The RTgill W1 cell line assay written by OECD and published by OECD Publishing. This book was released on 2021-06-18 with total page 51 pages. Available in PDF, EPUB and Kindle. Book excerpt: The RTgill-W1 cell line assay describes a 24-well plate format fish cell line acute toxicity test using the permanent cell line from rainbow trout (Oncorhynchus mykiss) gill, RTgill-W1. After 24 h of exposure to the test chemical, cell viability is assessed based on three fluorescent cell viability indicator dyes, measured on the same set of cells. Resazurin enters the cells in its non-fluorescent form and is converted to the fluorescent product, resorufin, by mitochondrial, microsomal or cytoplasmic oxidoreductases.

Download or read book Big Data in Predictive Toxicology written by Daniel Neagu and published by Royal Society of Chemistry. This book was released on 2019-12-04 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rate at which toxicological data is generated is continually becoming more rapid and the volume of data generated is growing dramatically. This is due in part to advances in software solutions and cheminformatics approaches which increase the availability of open data from chemical, biological and toxicological and high throughput screening resources. However, the amplified pace and capacity of data generation achieved by these novel techniques presents challenges for organising and analysing data output. Big Data in Predictive Toxicology discusses these challenges as well as the opportunities of new techniques encountered in data science. It addresses the nature of toxicological big data, their storage, analysis and interpretation. It also details how these data can be applied in toxicity prediction, modelling and risk assessment. This title is of particular relevance to researchers and postgraduates working and studying in the fields of computational methods, applied and physical chemistry, cheminformatics, biological sciences, predictive toxicology and safety and hazard assessment.