Comments on the scientific validation and regulatory acceptance of in vitro toxicity tests

M Balls, RH Clothier - Toxicology in vitro, 1991 - Elsevier
The 1980s saw widespread acceptance of the Three Rs (reduction, refinement,
replacement) concept of alternatives, and a great deal of effort was put into the development …

The validation and acceptance of alternatives to animal testing

M Balls, JH Fentem - Toxicology in vitro, 1999 - Elsevier
Validation is the key to the regulatory status of alternative methods. A series of questions are
put, to which answers are given, including the following: What is validation? What is meant …

How Much Flexibility is Possible When Validating New In Vivo and In Vitro Toxicity Test Methods?

RD Combes, M Balls - Alternatives to Laboratory Animals, 2003 - journals.sagepub.com
Validation involves assessing the reliability and relevance of a test method for a specific
purpose. 1 The need to validate a test method can arise from its possible use in-house, or its …

Scientific validation: a crucial and unavoidable prerequisite to the acceptability of new tests and testing strategies

M Balls - Alternatives to Laboratory Animals, 1995 - journals.sagepub.com
—The use of in vitro techniques in fundamental pharmacotoxicological research is
widespread, but relatively little progress has been made in applying the knowledge and …

Practical Aspects of the Validation of Toxicity Test Procedures: The Report and Recommendations of ECVAM Workshop 5,

M Balls, BJ Blaauboer, JH Fentem… - Alternatives to …, 1995 - journals.sagepub.com
This is the report of the fifth of a series of workshops organised by the European Centre for
the Validation of Alternative Methods (ECV AM). ECV AM's main goal, as defined in 1993 by …

Validation: A highly charged concept

H Koeter - Toxicology in vitro, 1995 - Elsevier
In order that a proposal for an alternative to an animal test be developed as an
internationally accepted guideline, there needs to be consensus on the validity of the …

Workshop overview: scientific and regulatory challenges for the reduction, refinement, and replacement of animals in toxicity testing

IFH Purchase, PA Botham, LH Bruner, OP Flint… - Toxicological …, 1998 - Elsevier
Public concern for animal welfare has been expressed through legislative control of animal
use for experimental purposes since the first legislation was introduced in 1876 in the United …

The Third FRAME Toxicity Committee: working toward greater implementation of alternatives in toxicity testing

RD Combes, M Balls, L Bansil… - Alternatives to …, 2004 - journals.sagepub.com
FRAME (the Fund for the Replacement of Animals in Medical Experiments; http://www.
frame. org. uk) is a scientific charity, which has, for over 30 years, been advocating and …

Acceptance of in vitro testing by regulatory authorities

MJ Van den Heuvel, RJ Fielder - Toxicology in vitro, 1990 - Elsevier
National regulatory authorities have responsibility for taking decisions that possibly affect the
health of whole populations and it is therefore to be expected that they will be reluctant to …

Validation of alternative methods for toxicity testing

LH Bruner, GJ Carr, M Chamberlain, RD Curren - Toxicology in Vitro, 1996 - Elsevier
Many studies have been conducted in order to assess the validity of alternative methods as
replacements forin vivo toxicity tests. The purpose of this review is to build on what has been …