(PRE)CLINICAL STUDIES
Preclinical studies
Orientating cytotoxicity studies for formulation
ThioMatrix performes orientating cytotoxicity studies in order to evaluate the influence of auxiliary agents and excipients on the toxicological potential of your drug. These studies include:
Development and validation of quantification methods
For in vivo studies with a new drug it is essential to establish an accurate and validated quantification method in order to be able to determine drug concentrations in compartments such as plasma or cerebrospinal fluid even in the picogram per ml range. ThioMatrix develops and validates such quantification methods and/or can assist you thereby.
In vivo studies
ThioMatrix designs and performs in vivo studies in small and large animals. Based on the results of such studies drug delivery systems can be optimised. ThioMartix is specialized on:
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tolerability studies
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dose finding studies
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pharmacokinetic studies
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biofeedback studies
Preparation of Common Technical Documents (CTDs) / Quality Overall Summaries (QOSs)
ThioMatrix has technical writing expertise and experience in all major therapeutic areas. We can help organize and prepare CTD and QOS in strict accordance with EU/ICH guidelines and regulations. In addition to traditional paper documents, we provide e-submission services.
Clinical studies
Orientating studies in humans
ThioMatrix organizes, designs and coordinates orientating studies in humans. In comparison to phase I-III clinical trials such orientating studies are more cost-effective in order to provide a proof of concept and/or to obtain data on which further improvements of the drug delivery system can be done.
Phase I-IV clinical trials
ThioMatrix works in conjunction with various CROs for clinical trials. ThioMatrix can therefore coordinate and/or assist projects from first orientating in vitro studies, through the resulting design of the delivery system, preclinical and clinical studies to final approval.
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