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Toxicological Studies
- Introduction
- Regulatory Requirements
- Study Design and Aim of Studies
- Acute Toxicity
- Single-Dose Toxicity
- Testing for Acute Dermal Irritation
- Testing for Acute Eye Irritation
- Test for Skin Sensitization
- Safety Pharmacology Studies
- Subchronic and Chronic Toxicity Studies
- Carcinogenicity Studies
- Genotoxicity Studies
- Methods for Detection of Gene Mutations
- Tests for Detection of Chromosome Aberrations
- DNA Indicator Tests
- Reproductive Toxicity Studies
- Aims and Issues in Statistical Analysis
- Aim of the Analysis
- Equivalence Tests—The Better Choice?
- Statistical Significance Vs. Toxicological Relevance
- Issue of Heterogeneous Variances
- Statistical Approaches
- Techniques to Improve Power of the Analysis
- Multiple Comparison Procedures
- Trend Test Vs. Pairwise Comparisons
- Pooling Control Groups
- One-Sided Testing vs. Two-Sided Testing
- Parametric Method Vs. Nonparametric Method
- Baseline Correction
- Statistical Tests
- Student’s t-Test
- Welch t-Test
- Williams Test
- Linear Contrasts Within an ANOVA
- ANOVA with Rank Transformations
- Wilcoxon Test
- Jonckheere–Terpstra Test
- Normal Range Comparisons
- Two Concepts for Analyzing Chronic or Subchronic Toxicity Studies
- Conclusion
- References
Abstract
Toxicology is defined as the knowledge of harmful effects of chemical substances on living organisms. The focus of this entry is on detailing several testing methods for determining toxicology and also stresses the importance of statistical analysis being performed before the study itself.
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