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Genesis Drug Discovery & Development is a proud member of Genesis Drug Discovery & Development (GD3), a fully integrated CRO providing services to support drug discovery programs of our clients from target discovery through IND filing and managing Phase I-III clinical trials.
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Dose range finding, MTD and MABEL Determination
In order to give your compounds their best chance of success in future preclinical models, a dose-range finding study will be required to get a preliminary understanding of tolerability. Careful observation of the effect of the compound on animal behavior, measurement of body weight, complete blood count (CBC) analysis and examination of organs for gross changes at necropsy can all provide additional information and understanding. Those organs in which changes are seen can be processed and fixed to allow optional histopathological examination. The development of biologics has resulted in the need to determine the minimum anticipated biological effect level (MABEL) to select the maximum recommended starting dose and dose escalation plan in the clinic. The MABEL is based on all appropriate information, including relevant animal models and ex vivo and in vitro mechanistic and toxicological studies, accounting for species-specific differences that impact the interpretation of study results.
GD3 scientists can collaborate with you in designing and interpreting these studies to select optimal doses for preclinical efficacy or toxicology studies and to provide data to assist in determining the MABEL.
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