31 Papers
288 Citations
Michael Balls is an academic researcher from Fund for the Replacement of Animals in Medical Experiments. The author has contributed to research in topics: European union & Drug development. The author has an hindex of 9, co-authored 31 publications.
Chat about Author
Papers
An analysis of the use of animal models in predicting human toxicology and drug safety.
TL;DR: Likelihood Ratios show that the absence of toxicity in the animal provides little or virtually no evidential weight that adverse drug reactions (ADRs) will also be absent in humans, and that alternative methods are urgently required for predicting human toxicity.
Toxicity testing: creating a revolution based on new technologies
TL;DR: The current and likely future value of these new technologies in relation to toxicological evaluation and the protection of human health are reviewed.
125
An analysis of the use of dogs in predicting human toxicology and drug safety.
TL;DR: Likelihood Ratios for an extensive dataset of 2,366 drugs with both animal and human data, including tissue-level effects and Medical Dictionary for Regulatory Activities Level 1–4 biomedical observations show that the absence of toxicity in dogs provides virtually no evidence that adverse drug reactions will also be absent in humans.
The Use of Basal Cytotoxicity and Target Organ Toxicity Tests in Hazard Identification and Risk Assessment
Michael Balls,Julia H. Fentem +1 more
TL;DR: It is concluded that the intelligent and strategic use of in vitro test systems, in conjunction with predictive computer modelling, could markedly improve the scientific basis of human risk assessment.
63
•Journal Article
Validation of alternative methods for the potency testing of vaccines.
Coenraad F.M. Hendriksen,Jean-Marc Spieser,A. Akkermans,Michael Balls,Lukas Bruckner,Klaus Cussler,A. Daas,J. Descamps,Roland Dobbelaer,Julia H. Fentem,Marlies Halder,M D van der Kamp,R. Lucken,Julie Milstien,Dorothea Sesardic,Donald W. Straughan,A. Valadares +16 more
TL;DR: This is the report of the thirty-first of a series of workshops organised by the European Centre for the Validation of Alternative Methods on specific topics, at which small groups of invited experts would review the current status of various types of in vitro tests and their potential uses, and make recommendations about the best ways forward.
45