Determining the degree of ocular irritation resulting from the test item introduced in a single dose
Testing of possible irritant effects of the test item on rabbit’s skin after a single application
Prediction of potentially serious adverse effects to the immune system caused by the test item
Evaluation of the mutagenic potential of the test item by measuring its ability to induce reverse mutations
Development of a selective method to quantify the compound in biological matrices
Validation of a method to quantify a test item in biological matrices
Investigation of systemic exposure and evaluate its gender-, time- and dose-dependency
Bioanalytical development, validation, measurement and PK evaluation in clinical studies
Determining the absolute or relative bioavailability of the test item
Assessment of the expected in vivo biological equivalence of two alternative test item formulations
Prediction of bioavailability of an orally administered test item with an in vitro assay
Detection of possible coagulation effects of the test item in human blood
Cytotoxicity screening based on colony formation of V79 cells
The aim of this assay is to test the complement activation ability of test antibodies or protein-based drugs
Measurement of cytokine release as a part of the immunological response investigation
Investigating the influence of a test item on presence and cytotoxic activity of T cells
Determination of the feasible test item dose for the start of the in vivo safety program
Detection and quantification of target molecules in biological matrices
Assessment and quantification of insulin sensitivity in the (mini)pig
Investigation of the rate and extent of total radioactivity excretion in bile
Developing and using of reliable HPLC/UV methods for the determination of test item concentration in dose formulations
Set up a method to determine quantitatively the test item concentration in animal dosing formulations
Performing a GLP-compliant validation of formulation analytical methods
Assessment and quantification of insulin sensitivity and investigation of its biological potency
Assessing the in vitro hemolytic potential of the test item in human whole blood
Evaluating the ability of a test item to induce an immediate hypersensitivity reaction
Determination of the number/ratio of different immune cells to follow the changes in the immune function/immune status of the animals
Demonstrating the presence and location of a protein in tissue sections
Demonstrating the presence and location of proteins in immune tissues
Gaining initial information about the effect of the test item on the immune system in the given species
Obtaining information on the number and type of metabolites
Comparison of metabolic behavior of the test item in different species in vitro
Detection of gene mutations induced by the test item
Obtaining information on the metabolic behavior of the test item in in vitro
Determining the binding properties of the test item to plasma proteins
The in vitro potency of the tested vaccine batch is evaluated
The vaccine uptake and infectivity of test batches are compared to those of reference material in an in vitro test
A useful assay to analyze the immunomodulatory potential of a test item is to analyze T-cell proliferation in vitro
Irritation potency assessment of a medical device following intradermal injection of extracts of the material
Assessment of biological safety after implantation of the biomaterial
Assessment of delayed-type of hypersensitivity reactions and identification of skin sensitizing substances
Test to assess the tolerance at the site of administration or potential unintended/accidental administration
Assessment of delayed type of hypersensitivity reaction caused by the test item
Identifying agents that cause structural chromosome aberrations in cultured mammalian cells
Determination if the test item can cause genotoxic effects
Investigating the rate and extent of the total radioactivity excretion in urine and feces
ELISA is a specific method to measure protein/nucleic acid levels in biological samples
Measurement of desired protein/nucleic acid levels in biological samples
Assessment of effects on NK cells caused by the test item
Investigation of the relationship between the pharmacodynamic/toxicity response and the exposure of the test item
Biological sample collection from test item free animals
Investigation of the distribution properties of the total radioactivity
Identify the test item toxicity after repeated administration
Evaluating the cardiovascular effect of the test item in vivo (in telemetered animals) and in vitro
Determination of neurobehavioral effects of the test item
Evaluating the effects of the test item on the respiratory functions
Investigation of the pharmacokinetic properties of a test item after single administration and under steady state
Identification of the test item toxicity after one or more doses during a period not exceeding 24 hours
Assessment of dermal irritation potency of the test item in the rabbit
Development of an animal test item dosing formulation to be administered in animal trials
Assessing the ability of a test system to mount an antibody response after immunization
Detection of adverse effects of veterinarian products in the target species
Identification of the possible structure of metabolites produced in vitro and/or in vivo
Immunohistochemical technique to characterize the binding of monoclonal antibodies to antigenic determinants in different tissues
Investigating the distribution properties of the test item
Investigating the distribution properties of the total radioactivity
Efficacy evaluation of a test item in a wound healing model using db/db mice or Zucker rats
Investigating the influence of the test item on wound healing in healthy pigs or minipigs
Assessment of the response of cells in culture to direct contact with devices or to their extracts in different concentrations