"The block of toxicology studies would consist of subacute and/or subchronic toxicity studies including safety pharmacology, pharmacodynamic and reproduction performance end points, stand-alone safety pharmacology studies (telemetry studies), pharmacokinetic studies. Non-clinical toxicity studies must be performed when the biological drug candidate is progressing through the clinical development (from Phase I to Phase III) i.e., chronic toxicity studies and reproduction toxicology studies (enhanced pre- and postnatal development studies in non-human primates or the classical segment II and III reproduction.
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Citation: Costa SL (2014) Antiglioma Potential of Flavonoides. J Bioanal Biomed 6: e124."
Last date updated on July, 2025
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