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Product Sheet

Acute eye irritation test in rabbit

Determining the degree of ocular irritation resulting from the test item introduced in a single dose

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Acute skin irritation test in rabbit

Testing of possible irritant effects of the test item on rabbit’s skin after a single application

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Anti-drug antibody (ADA) assay

Prediction of potentially serious adverse effects to the immune system caused by the test item

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Antibody dependent cell-mediated cytotoxicity (ADCC)

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Bacterial reverse mutation test (Ames test)

Evaluation of the mutagenic potential of the test item by measuring its ability to induce reverse mutations

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Bioanalytical method development

Development of a selective method to quantify the compound in biological matrices

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Bioanalytical method validation

Validation of a method to quantify a test item in biological matrices

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Bioanalytical part of toxicokinetic studies

Investigation of systemic exposure and evaluate its gender-, time- and dose-dependency

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Bioanalytical support of clinical trials

Bioanalytical development, validation, measurement and PK evaluation in clinical studies

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Bioavailability study

Determining the absolute or relative bioavailability of the test item

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Bioequivalence studies in animals

Assessment of the expected in vivo biological equivalence of two alternative test item formulations

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CaCo-2 transmembrane permeability/efflux assay

Prediction of bioavailability of an orally administered test item with an in vitro assay

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Coagulation assay

Detection of possible coagulation effects of the test item in human blood

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Colony forming assay in V79 cells

Cytotoxicity screening based on colony formation of V79 cells

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Complement dependent cytotoxicity (CDC)

The aim of this assay is to test the complement activation ability of test antibodies or protein-based drugs

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Cytokine release assay

Measurement of cytokine release as a part of the immunological response investigation

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Cytotoxic T-cell (CTL) function assay

Investigating the influence of a test item on presence and cytotoxic activity of T cells

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Dose range finding

Determination of the feasible test item dose for the start of the in vivo safety program

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ELISA method transfer/development and validation

Detection and quantification of target molecules in biological matrices

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Euglycemic clamp test

Assessment and quantification of insulin sensitivity in the (mini)pig

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Excretion in bile (14C, 3H, 125l, 32P)

Investigation of the rate and extent of total radioactivity excretion in bile

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Formulation analysis of dose formulations in toxicity studies

Developing and using of reliable HPLC/UV methods for the determination of test item concentration in dose formulations

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Formulation analytical method development

Set up a method to determine quantitatively the test item concentration in animal dosing formulations

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Formulation analytical method validation

Performing a GLP-compliant validation of formulation analytical methods

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Glucose tolerance test

Assessment and quantification of insulin sensitivity and investigation of its biological potency

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Hemolysis assay

Assessing the in vitro hemolytic potential of the test item in human whole blood

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Immediate hypersensitivity reaction (IHR) / Passive Cutaneous Anaphylaxis (PCA)

Evaluating the ability of a test item to induce an immediate hypersensitivity reaction

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Immune cell phenotyping

Determination of the number/ratio of different immune cells to follow the changes in the immune function/immune status of the animals

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Immunohistochemical analysis

Demonstrating the presence and location of a protein in tissue sections

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Immunohistochemistry of immune tissues

Demonstrating the presence and location of proteins in immune tissues

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Immunotoxicological evaluation within toxicity studies

Gaining initial information about the effect of the test item on the immune system in the given species

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In vitro and in vivo metabolic profiling

Obtaining information on the number and type of metabolites

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In vitro inter-species comparison of metabolism

Comparison of metabolic behavior of the test item in different species in vitro

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In vitro mammalian cell gene mutation assay

Detection of gene mutations induced by the test item

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In vitro metabolic stability

Obtaining information on the metabolic behavior of the test item in in vitro

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In vitro plasma protein binding

Determining the binding properties of the test item to plasma proteins

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In vitro potency assay of the expression level of protein of interest

The in vitro potency of the tested vaccine batch is evaluated

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In vitro potency assay of the infectivity of an oral vaccine

The vaccine uptake and infectivity of test batches are compared to those of reference material in an in vitro test

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In vitro T-cell proliferation assay

A useful assay to analyze the immunomodulatory potential of a test item is to analyze T-cell proliferation in vitro

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Intracutaneous reactivity in the rabbit

Irritation potency assessment of a medical device following intradermal injection of extracts of the material

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Local effects after implantation of medical device

Assessment of biological safety after implantation of the biomaterial

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Local lymph node assay in the mouse

Assessment of delayed-type of hypersensitivity reactions and identification of skin sensitizing substances

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Local tolerance testing (in vivo)

Test to assess the tolerance at the site of administration or potential unintended/accidental administration

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Magnusson and Kligmann maximisation test

Assessment of delayed type of hypersensitivity reaction caused by the test item

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Mammalian chromosome aberration test

Identifying agents that cause structural chromosome aberrations in cultured mammalian cells

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Mammalian erythrocyte micronucleus test

Determination if the test item can cause genotoxic effects

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Mass balance (14C, 3H, 125l, 32P)

Investigating the rate and extent of the total radioactivity excretion in urine and feces

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Measurement of protein/nucleic acid level with ELISA

ELISA is a specific method to measure protein/nucleic acid levels in biological samples

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Measurement of protein/nucleic acid level with Luminex Multiplex Assay

Measurement of desired protein/nucleic acid levels in biological samples

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Natural killer cell (NK) activity assay

Assessment of effects on NK cells caused by the test item

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Pharmacokinetic support of pharmacological/ toxicity studies

Investigation of the relationship between the pharmacodynamic/toxicity response and the exposure of the test item

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Providing blank samples for bioanalysis

Biological sample collection from test item free animals

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Quantitative whole body autoradiography

Investigation of the distribution properties of the total radioactivity

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Repeated dose toxicity studies

Identify the test item toxicity after repeated administration

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Safety pharmacology core battery: Cardiovascular system

Evaluating the cardiovascular effect of the test item in vivo (in telemetered animals) and in vitro

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Safety pharmacology core battery: Nervous system

Determination of neurobehavioral effects of the test item

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Safety pharmacology core battery: Respiratory system

Evaluating the effects of the test item on the respiratory functions

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Single and multiple dose pharmacokinetic study

Investigation of the pharmacokinetic properties of a test item after single administration and under steady state

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Single dose toxicity study / Extended single dose toxicity

Identification of the test item toxicity after one or more doses during a period not exceeding 24 hours

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Skin irritation test in the rabbit (single and repeated exposure)/ medical device

Assessment of dermal irritation potency of the test item in the rabbit

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Support for formulation development

Development of an animal test item dosing formulation to be administered in animal trials

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T-cell dependent antibody response (TDAR)

Assessing the ability of a test system to mount an antibody response after immunization

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Target animal safety studies

Detection of adverse effects of veterinarian products in the target species

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Tentative metabolite identification

Identification of the possible structure of metabolites produced in vitro and/or in vivo

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Tissue cross reactivity (TCR) testing

Immunohistochemical technique to characterize the binding of monoclonal antibodies to antigenic determinants in different tissues

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Tissue distribution with non-radiolabeled test item

Investigating the distribution properties of the test item

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Tissue distribution with radiolabeled test item

Investigating the distribution properties of the total radioactivity

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Wound healing in db/db mice or in Zucker-rat

Efficacy evaluation of a test item in a wound healing model using db/db mice or Zucker rats

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Wound healing in the (mini) pig

Investigating the influence of the test item on wound healing in healthy pigs or minipigs

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XTT cytotoxicity assay

Assessment of the response of cells in culture to direct contact with devices or to their extracts in different concentrations

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