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This unit describes the functional observational battery (FOB), a behavioral screening procedure commonly used in safety pharmacology and toxicology studies to assess potentially adverse effects of… Continue Reading
In conclusion, high quality cardiovascular telemetry recording is now possible in non-human primates pair-housed in large cages, therefore complying with the new directive 2010/63/UE. The new housing… Continue Reading
The integration of safety pharmacology endpoints into early toxicology studies brings scientific, practical and ethical benefits, and there has been increasing interest in such approaches. In this… Continue Reading
The ICH S7b Guideline requires the use of the most appropriate in vivo species for the assessment of test substance potential to delay ventricular repolarization. Dogs and monkeys are the non-rodent… Continue Reading
Evaluation of the auditory function is part of the functional assessment of the Central Nervous System in the follow-up studies mentioned in ICH S7A guideline for Safety Pharmacology Studies for… Continue Reading
Assessment of a drug effect on the Central Nervous System (CNS) during the preclinical development of a new chemical entity is part of the ICH S7A guideline on Safety Pharmacology studies for human… Continue Reading