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Multi-site studies and field studies
Published 2012Table of Contents: “…Contents: Conduct of multi-site and field studies in compliance with the OECD Principles of GLP -- Context, issues and complexities -- Responsibilities of test facility and test site personnel and sponsor -- Importance of communication -- Master schedule requirements for test sites -- Study plan requirements (with special reference to flexibility required for field studies) -- Performance of the study (with special reference to general facilities and to facilities for handling test and reference items and documentation required for field studies) -- Equipment, control and accountability of study materials for multi-site studies -- Reporting of study results -- Standard Operating Procedures -- Archives.…”
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Electronic Video -
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In vitro studies and short term studies
Published 2013Table of Contents: “…Contents: In vitro studies -- Short-term studies -- Acute toxicity studies -- Acute ecotoxicological studies -- Genetic toxicity testing -- Standardized general study plan -- Study-specific supplement -- Standardised final report -- Process-based inspections -- Standard operating procedures -- Test item -- Reference item -- Contamination of batches -- Characterisation of culture media -- Predictive capacity of in-vitro studies -- Assessment of health effects.…”
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Electronic Video -
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