In order to develop a novel compound to become a safe and effective treatment, a package of studies is required. Often these study designs need to be tailored for each compound in development. This requirement is partnered with the need for accurate assessment of safety data, confidence in this data, and often requires delivery within tight timescales.
Aptuit’s Preclinical Biosciences group has the know-how and experience to design and execute all of these study requirements from a single source. More importantly, they have the experience and the confidence in their data to provide an accurate and balanced assessment of preclinical safety, even when these studies are on tight timelines.
This expertise is further enhanced with the support and experience of our Consulting and Project Management teams, ensuring your product moves beyond preclinical regulatory requirements, getting a significant head start to proof of concept and beyond.
Aptuit recognizes the important steps involved in taking a pharmaceutical new chemical entity from drug discovery through to IND submission and first in man dosing. Our pharmacology services provide early-stage efficacy evaluations to aid candidate selection. Our approach to evaluate early a biological target through the eyes of a toxicologist (Early Safety Prediction) and to raise early possible structure related effects of a molecule (Computational Toxicology), adds robustness to the discovery process. Our unique ‘First in Man-enabling’ fully integrated drug-development program provides the mandatory core battery of safety studies, and also a series of recommended in vitro drug metabolism studies to enhance understanding of the pharmacokinetic profile and metabolism.
Emerging Drug Technologies
Other families of compounds (e.g. biologics) or indications (e.g. oncology) warrant different strategies. Taking advantage of our immunology
expertise and immunoassay
platform, we are in the ideal position to support projects in biologics area. Moreover, thanks to our strong molecular expertise, we can perform the preclinical safety evaluation of gene therapy studies.
Our full complement of technologies includes: