ECVAM

/Tag:ECVAM

The Use of Human Keratinocytes and Human Skin Models for Predicting Skin Irritation

Johannes van de Sandt, Roland Roguet, Catherine Cohen, David Esdaile, Maria Ponec, Emanuela Corsini, Carol Barker, Norbert Fusenig, Manfred Liebsch, Diane Benford, Anne de Brugerolle de Fraissinette and Manigé Fartasch

This is the report of the thirty-eighth of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM’s main goal, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine or replace the use of laboratory animals.
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:27:00+00:00 Tags: , |

Biomarkers as Predictive Tools in Toxicity Testing

Diane J. Benford, A. Bryan Hanley, Krys Bottrill, Sarah Oehlschlager, Michael Balls, Francesco Branca, Jean Jaques Castegnaro, Jaques Descotes, Kari Hemminiki, David Lindsay and Benoit Schilter

This is the report of the fortieth of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM’s main goal, as defined in
1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine or replace the use of laboratory animals.
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:27:08+00:00 Tags: , |

Three Rs Approaches in the Production and Quality Control of Avian Vaccines

Lukas Bruckner, Johan Bongers, Peter Castle, Pieter H. Flore, Michèle Guittet, Marlies Halder, Carmen Jungbäck, François Xavier Le Gros, Maria Tollis, Venugopal K. Nair, Manfred Wilhelm, Joseph Zeegers and Guy Zigterman

This is the report of the forty-first of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM’s main goal, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine or replace the use oflaboratory animals. One of the first priorities set by ECVAM was the implementation of procedures which would enable it to become well informed about the state-of-the-art of non-animal test development and validation, and the potential for the possible incorporation of alternative tests into regulatory procedures. It was decided that this would be best achieved by the organisation of ECVAM workshops on specific topics, at which small groups of invited experts would review the current status of various types of in vitrotests and their potential uses, and make recommendations about the best ways forward (1).
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:27:09+00:00 Tags: , |

ECVAM News & Views

ATLA Staff Writer

Statement on the Application of the Epiderm ™ Human Skin Model for Skin Corrosivity Testing
Statement on the Validity of the Local Lymph Node Assay for Skin Sensitisation Testing
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:27:11+00:00 Tags: |

ECVAM News & Views

ATLA Staff Writer

Statement on the Application of the ELISA Procedure for the Batch Potency Testing of Tetanus Vaccines for Human Use
Statement on the Application of the CORROSITEX® Assay for Skin Corrosivity Testing
Statement on the Use of Animals in Research
Statement on the Application of the ToBI Test for the Batch Potency Testing of Tetanus Vaccines for Human Use
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:28:08+00:00 Tags: |

Novel Pyrogen Tests Based on the Human Fever Reaction

Thomas Hartung, Ingeborg Aaberge, Susanne Berthold, Gunnar Carlin, Emmanuelle Charton, Sandra Coecke, Stefan Fennrich, Matthias Fischer, Martin Gommer, Marlies Halder, Kaare Haslov, Michael Jahnke, Thomas Montag-Lessing, Stephen Poole, Leonard Schechtman, Albrecht Wende and Gabriele Werner-Felmayer

This is the report of the forty-third of a series of workshops organised by the European Cen - tre for the Validation of Alternative Methods (ECVAM). ECVAM’s main goal, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences, and which reduce, refine or replace the use of laboratory animals. One of the first priorities set by ECVAM was the implementation of procedures which would enable it to become well informed about the state of the art of non-animal test development and validation, and the potential for the possible incorporation of alternative tests into regulatory procedures. It was decided that this would best be achieved by the organisation of ECVAM workshops on
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:28:08+00:00 Tags: , |

The Establishment of Human Research Tissue Banking in the UK and Several Western European Countries

Robert Anderson, Michael Balls, M. Danny Burke, Marie Cummins, Deirdre Fehily, Neil Gray, Marleen G. de Groot, Heikki Helin, Charles Hunt, David Jones, David Price, Lysiane Richert, Rivka Ravid, David Shute, Dariusz Sladowski, Helena Stone, Wolfgang Thasler, Jacki Trafford, Jan van der Valk, Thomas Weiss, Chris Womack, and Timo Ylikomi

This is the report of the forty-fourth of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM’s main goal, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine or replace the use of laboratory animals. One of the first priorities set by ECVAM was the implementation of procedures that would enable it to become well-informed about the state-of-the-art of non-animal test development and validation, and the potential for the possible incorporation of alternative tests into regulatory procedures. It was decided that this would be best achieved by the organisation of ECVAM workshops on specific topics, at which small groups of invited experts would review the current status of in vitro tests and their potential uses, and make recommendations about the best ways forward (1). In addition, other topics relevant to the Three Rs concept of alternatives to animal experiments have been considered in several ECVAM workshops.
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:28:10+00:00 Tags: , |

The Importance of the Prediction Model in the Validation of Alternative Tests

Andrew P. Worth and Michael Balls

An overview is presented of the validation process adopted by the European Centre for the Validation of Alternative Methods, with particular emphasis on the central role of the prediction model (PM). The development of an adequate PM is considered to be just as important as the development of an adequate test system, since the validity of an alternative test can only be established when both components (the test system and the PM) have successfully undergone validation. It is argued, however, that alternative tests and their associated PMs do not necessarily need to undergo validation at the same time, and that retrospective validation may be appropriate when a test system is found to be reliable, but the case for its relevance remains to be demonstrated. For an alternative test to be considered "scientifically valid", it is necessary for three conditions to be fulfilled, referred to here as the criteria for scientific relevance, predictive relevance, and reliability. A minimal set of criteria for the acceptance of any PM is defined, but it should be noted that required levels of predictive ability need to be established on a case-by-case basis, taking into account the inherent variability of the alternative and in vivo test data. Finally, in view of the growing shift in emphasis from the use of standalone alternative tests to alternative testing strategies, the importance of making the PM an integral part of the testing strategy is discussed.
You need to register (for free) to download this article. Please log in/register here.

ECVAM News & Views

ATLA Staff Writer

Statement on Proposals for a Seventh Amendment to Directive 76/768/EEC on the Approximation of the Laws of the Member States relating to Cosmetic Products
ECVAM Staffing
The ECVAM Initiative on Alternative Methods for Chemicals Testing
Comments on the ESAC statement on proposals for a seventh amendment to the Cosmetics Directive
Participation in ECVAM studies
ECVAM reports
You need to register (for free) to download this article. Please log in/register here.
2017-01-09T06:28:29+00:00 Tags: |

The Role of ECVAM in Promoting the Regulatory Acceptance of Alternative Methods in the European Union

Andrew P. Worth and Michael Balls

The roles played by the European Centre for the Validation of Alternative Methods (ECVAM) and its advisory committee, the ECVAM Scientific Advisory Committee (ESAC), in the evolution of alternative methods are described. Particular emphasis is given to the process by which ECVAM and the ESAC assess the scientific validities of alternative methods, and, in appropriate cases, initiate the progression of scientifically validated methods toward regulatory acceptance.
You need to register (for free) to download this article. Please log in/register here.