Before a new candidate drug enters human clinical trials, safety and tolerability must be assessed in preclinical rodent and non-rodent toxicology studies. The studies are not just as a regulatory requirement, more importantly, to assess, limit and manage risk to human volunteers or patients. Generally, acute and chronic toxicity work begins with MTD/DRF studies that establish the maximum tolerated dose and define the dose-response curve to set doses for the one-month rodent and non-rodent GLP studies. The data from the one-month GLP studies form the basis of the risk assessment for Phase I, are used to set starting doses and exposure limits based on the nonclinical no adverse effect level (NOAEL) and may inform any additional clinical monitoring. Data from subsequent chronic toxicology studies is used to support larger phase II and phase III clinical trials and is required for registration.
All these preclinical toxicity detections can be conducted at Creative Animodel. Acute Toxicity— Describe the adverse effects of a substance that result either from a single exposure or from multiple exposures in a short space of time (usually less than 24 hours).Accumulation Toxicity— Investigate the accumulation of drugs and their metabolic byproducts in organs can be toxic, leading to organ damage.Sub-chronic Toxicity— Study if the toxic substance has the ability to cause effects for more than one year but less than the lifetime of the exposed organism.Chronic Toxicity— Test the toxic effects on a living organism under continuously or repeatedly exposed to a toxic substance.Dose Ranging Study— Estimate the response and dose given, so as to analyze the efficacy and safety of a substance or treatment.Maximum Tolerated Dose (MTD) Study— Describe the highest dose of a treatment or medicine that will produce the desired effect without causing unacceptable side effects or overt toxicity in a specific period of time.
Our AdvantagesWide range of species (rodents, rabbits, mini pigs and non-human primates)Multiple routes of administration (oral, intravenous (IV), intramuscular (IM), subcutaneous (SC), intradermal (ID) and inhalation)High-quality data and low time-cost
Creative Animodel's work is GLP compliant and AAALAC-accredited. Plus, we have a thorough understanding of global regulatory issues and can help ensure that you are conducting the right studies at each step of the process. Moreover, our facilities are outfitted with the very latest technology for data measurement, data collection, and animal care. Please let us know how we can help you.
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