Profit from Aurigon’s long-standing expertise in the development of small molecules
For more than 30 years our scientists are gaining expert knowledge in the development of chemical compounds into pharmaceutical products. With a vita combining academic research, big pharma drug development experience and client oriented service performance, they are the perfect partner for testing of small molecules with challenging chemico-physical properties.
Our facilities and services cover all requirements of the non-clinical testing of NCEs:
Pharmaco- and toxicokinetic sample measurement including statistical evaluation with acknowledged and validated tools (WinNonLin, SAS)
Studies performed according to the latest FDA, EMA, ICH and OECD guidelines
GLP-compliant animal houses, quality assurance and audit reports for all GLP-compliant studies
Multiple modes of administration (incl. long-term infusion, s.c. osmotic mini-pump, transdermal)
Animal handling according to the 2010/63/EU guideline and under the control of the Institutional Animal Care and Use Committee
Explore our special services for the pharmaceutical development of small molecules:
Expertise in the bioanalytical support of clinical trials I to IV
Expert data interpretation: dosimetry calculation for human metabolic study and FIM dose prediction
SERVICE LIST
GENERAL TOXICOLOGY
- Dose range finding
- Single dose toxicity study / Extended single dose toxicity
- Repeated toxicity studies
- Local tolerance testing (in vivo)
- Target animal safety studies
GENOTOXICITY
- Bacterial reverse mutation test (Ames test)
- XTT cytotoxicity assay
- In vitro mammalian cell gene mutation assay
- Mammalian chromosome aberation test
SAFETY PHARMACOLOGYSTUDIES
- Safety pharmacology core battery: Nervous system
- Safety pharmacology core battery: Respiratory system
- Safety pharmacology core battery: Cardiovascular system
IRRITATION AND DELAYED-TYPE
HYPERSENSITIVITY
- Acute skin irritation test in the rabbit
- Acute eye irritation test in the rabbit
IMMUNOTOXICITY
- Immunotoxicological evaluation within toxicity studies
OTHER IN VITRO TESTS / STANDARD AND SPECIAL SERVICES
- Hemolysis assay
- Coagulation assay
PHARMACOKINETIC STUDIES
- Single and multiple dose pharmacokinetic studies
- Bioequivalence studies in animals
- Toxicokinetic support of toxicological/toxicity studies
- Bioavailability study
- CaCo-2 transmembrane permeability/ efflux assay
TISSUE DISTRIBUTION
- Tissue distribution study with non-radiolabeled test items
METABOLISM STUDIES
- In vitro metabolic stability
- In vitro inter-species comparison of metabolism
- In vitro metabolic profiling
- Tentative metabolite identification
BIOANALYTICAL ACTIVITIES
- Bioanalytical method development
- Bioanalytical method validation
- Bioanalytical part of toxicokinetic studies
- Bioanalytical support of clinical trials
QUALITY CONTROL ACTIVITIES
- Formulation analysis of dose formulations in toxicity studies
- Formulation analytical method development
- Formulation analytical method validation
- Support for formulation development
EXPERTISE
- Bacterial reverse mutation test (Ames test)
- Mammalian erythrocyte micronucleus test
- Safety pharmacology core battery: Cardiovascular system
- Safety pharmacology core battery: Respiratory system
- Hemolysis assay
- Coagulation assay
- Food effect on plasma kinetics
- Pharmacokinetic support of pharmacological/toxicity studies
- Bioanalytical support of clinical trials
- Bioavailability study – 1
- Bioavailability study – 2
- CaCo-2 transmembrane permeability/efflux assay
- Tissue distribution and persistence study with non-radiolabeled test item