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Case Study

Bacterial reverse mutation test (Ames test)

Bacterial reverse mutation assay with a quinolone analogue

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Case Study

Bioanalytical support of clinical trials

Phase I trial: serum levels of parent drug in a Phase I/a ascending dose trial (N=30)

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Case Study

Bioavailability study-1

Plasma kinetics of the total radioactivity (LSC) and the parent compound (LC-MS/MS) in rats.

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Case Study

Bioavailability study-2

Relative bioavailability study: comparison of different doses and formulations after repeated topical administration in minipigs

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Case Study

CaCo-2 transmembrane permeability/efflux assay

Bidirectional P-glycoprotein assay of a radiolabelled test compound

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Case Study

Coagulation assay

In vitro coagulation test of an anticancer compound in human whole blood

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Case Study

Cytokine release assay

Cytokine measurement within a 14-day intravenous toxicity study with a humanized immunoglobulin in rats

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Case Study

Euglycemic clamp test

Investigation of in vivo biological potency of an intravenous insulin compound with euglycemic clamp technique in minipigs

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Case Study

Excretion and metabolite mass balance

Urinary excretion of the non-radiolabelled parent drug and its metabolites in humans

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Case Study

Excretion balance

Excretion (mass balance) study with radiolabeled test item

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Case Study

Food effect on plasma kinetics

Food Effect Study of a non-competitive AMPA antagonist

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Case Study

Hemolysis assay

Investigation of hemolytic potential of an anticancer compound using validated in vitro hemolysis assay in human whole blood

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Case Study

Immune cell phenotyping

Lymphocyte phenotyping within a 14-day intravenous toxicity study with a humanized immunoglobulin in rats

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Case Study

Immunohistochemical analysis

Quasi-quantitative analysis of protein expression in minipig skin tissue – Ki67

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Case Study

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

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

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Case Study

In vitro potency assay of the infectivity of an oral vaccine

Phagocytosis assay with bacteria – uptake of bacteria with induced human histiocytic lymphoma U937 cells

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Case Study

Mammalian erythrocyte micronucleus test

In vivo mouse micronucleus test with an NK-1 antagonist

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Case Study

Pharmacokinetic support of pharmacological/toxicity studies

Toxicokinetic study with administration by inhalation route: plasma kinetics of the parent compound in rats on first & last days.

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Case Study

Quantitative whole body autoradiography

Tissue distribution study with a 14C-labeled test item in the rat

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Case Study

Repeated dose toxicity study

Repeated dose toxicity study by intranodal administration of an allergen in the beagle dog

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Case Study

Safety pharmacology core battery: Cardiovascular system

Assessment of cardiovascular effects and potential for QT interval prolongation after single intravenous administration of an NK-1 antagonist in telemetered conscious dogs

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Case Study

Safety pharmacology core battery: Respiratory system

Assessment of respiratory effects after single intravenous administration of an NK-1 antagonist in Wistar rats

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Case Study

Tissue cross reactivity-1

Tissue cross reactivity investigation of an antibody product in human frozen tissues

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Case Study

Tissue cross reactivity-2

Tissue cross reactivity investigation of an antibody product in human frozen tissues

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Case Study

Tissue distribution and persistence study with non-radiolabeled test item

Non-clinical ADME-PK: pharmacokinetics of a a1-antagonist in various tissues of the rat

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Case Study

XTT cytotoxicity assay

In vitro XTT cytotoxicity assay with a medical device

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