"The toxicity profiling of biological molecules or biopharmaceuticals during the regulatory preclinical development is divided in two blocks, one consisting in a series of preliminary toxicity studies like the Dose Range Finder (DRF), the Maximum Tolerated Dose (MTD) and an early assessment of the pharmacokinetic behavior associated or not with a pharmacodynamic assessment. Most of those studies performed at this stage of the toxicity profiling are not required to be performed under Good Laboratory Practice.
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Citation: Maraschiello C (2014) The Relevance of Immunogenicity in Preclinical development. J Bioanal Biomed 6: 001-004."
Last date updated on September, 2020