Issues Relating to the Release of Proprietary Information and Data for Use in the Validation of Alternative Methods

This is the report of the twenty-seventh 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 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 vitro tests and their potential uses, and make recommendations about the best ways forward (1). The workshop on Issues Relating to the Release of Proprietary Information and Data for Use in the Validation of Alternative Methods was held in Munich, Germany, on 9–11 May 1997, under the co-chairmanship of Martin Todd (ZENECA Pharmaceuticals, Macclesfield, UK) and Bernward Garthoff (Bayer, Leverkusen, Germany). The main Issues Relating to the Release of Proprietary Information and Data for Use in the Validation of Alternative Methods The Report and Recommendations of ECVAM Workshop 27

[1]  W Slob,et al.  Conversion factors estimating indicative chronic no-observed-adverse-effect levels from short-term toxicity data. , 1996, Regulatory toxicology and pharmacology : RTP.

[2]  A M Goldberg,et al.  The Three Rs: The Way Forward , 1995, Alternatives to laboratory animals : ATLA.

[3]  J. P. Van Oosterhout,et al.  The utility of two rodent species in carcinogenic risk assessment of pharmaceuticals in Europe. , 1997, Regulatory toxicology and pharmacology : RTP.

[4]  Horst Spielmann,et al.  Alternatives to the Animal Testing of Medical Devices , 1996 .

[5]  S. Walker,et al.  The value of chronic animal toxicology studies of pharmaceutical compounds: A retrospective analysis. , 1985, Fundamental and applied toxicology : official journal of the Society of Toxicology.

[6]  U. Sauer,et al.  Current Status and Future Developments of Databases on Alternative Methods , 1997 .

[7]  Michael Balls,et al.  The three Rs: the way forward: the report and recommendations of ECVAM Workshop 11. , 1995, Alternatives to laboratory animals : ATLA.

[8]  W. Russell,et al.  The Three Rs: The Way Forward , 1995 .

[9]  J B Houston,et al.  Pharmacokinetics in Early Drug Research , 1997, Alternatives to laboratory animals : ATLA.

[10]  Alessandro Giuliani,et al.  The Integrated Use of Alternative Approaches for Predicting Toxic Hazard , 1995 .

[11]  P. H. Bach,et al.  The Use of Tissue Slices for Pharmacotoxicology Studies , 1996 .

[12]  S. Walker,et al.  An International Appraisal of the Minimum Duration of Chronic Animal Toxicity Studies , 1992, Human & experimental toxicology.

[13]  M. Pieters,et al.  A No-Observed-Adverse-Effect Level of 1000 Mg/Kg in A 28-Day Repeated-Dose Study as a Limit Value for Acute Toxicity Testing , 1998 .