the Design, Analysis, and Interpretation of Long-Term Animal Studies
First Statement of Responsibility
edited by Harold C. Grice, Joseph L. Ciminera.
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Berlin, Heidelberg
Name of Publisher, Distributor, etc.
Springer Berlin Heidelberg
Date of Publication, Distribution, etc.
1988
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
(xix, 279 pages)
SERIES
Series Title
ILSI monograph.
CONTENTS NOTE
Text of Note
Biological and Statistical Assumptions in Analyses of the Bioassay --; Value of Historical Control Data --; Dose Selection --; Criteria for Classifying Neoplasms and Use of Data on Nonneoplastic Lesions --; Observer Bias in Histopathological Examinations --; Modulating Factors: Challenges to Experimental Design --; Options for Aggregation of Incidence Data --; Reevaluation of Pathology Data in Regulatory Decision Process --; Interpretation of Multiple Studies and Design of Repeat Studies --; Issues in Decision Making --; Index.
SUMMARY OR ABSTRACT
Text of Note
Critical issues in the design, evaluation and interpretation of long-term animal carcinogenicity studies are addressed in this volume. The presentations are by top pathologists, toxicologists and statisticians in the USA, Canada and Europe, representing industry, academia and regulatory agencies. The discussions involve controversial as well as conventional issues and are presented from statistical and biological or toxicological perspectives. Although more work has been done and published on long-term animal carcinogenicity studies than in any other phase of chemical or drug safety assessment, many issues still remain unresolved. Some solutions have been proposed, but in many instances they have not proven to be completely remedial. This volume continues important discussion of these issues and proposed solutions, and should be of interest to scientists engaged in long-term animal carcinogenicity testing.
PARALLEL TITLE PROPER
Parallel Title
Proceedings of the Interdisciplinary Discussion Group on Carcinogenicity Studies Held in Chapel Hill, NC, June 23-26, 1986