E-BOOK: Preclinical Toxicology Reference Guide, 1st Edition

Toxicity is categorized as acute or chronic depending on the exposure of a molecule to biological tissues.

The stepwise preclinical toxicity evaluation in drug development has the primary goal to characterize the potential dose-related adverse effects at the level of tissue, organs, and organ system. Preclinical toxicity and safety evaluation can be helpful to determine a safe starting dose of a pharmaceutical
for human testing.

This guide provides an overview of preclinical and non-clinical safety and toxicology studies necessary to be conducted for a successful IND submission and advance a drug candidate through the development phase and covers the following concepts:

  • REGULATORY CONSIDERATIONS FOR CONDUCTING PRE-CLINICAL TOXICOLOGY STUDIES 
  • CONSIDERATIONS FOR GENERAL TOXICOLOGY EVALUATION 
  • COMPONENTS OF GENERAL TOXICITY EVALUATION IN GLP STUDIES
  • OCULAR TOXICITY EVALUATION
  • DERMAL TOXICITY EVALUATION

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