Register

Company Profile

Sourcing Inquiry Logo ATRC Aurigon Toxicological Research Center

ATRC Aurigon Toxicological Research Center

Regions
Europe
Countries
Hungary
Size
50-100
Specialty
Human Medicines, Biopharmaceuticals, …
Specialty
Human Medicines, Biopharmaceuticals, Generics, Animal Medicines, Medical Devices
Service category
Pre-clinical development and testing, pre-clinical CRO, Analytical laboratory and testing services
Content posted and uploaded by users. Want to add your company?
Your company? Get access to this profile.

Key services

Services

A brief overview of our comprehensive range of services:

 

Wide range of pharmaceutical / healthcare categories

  • New Chemical Entities (NCE)
  • Generics
  • Herbal Medicinal Products
  • Food / Food Ingredients
  • New Biological Entities (NBE)
  • Biosimilars / Biobetters
  • Vaccines / Immunotherapies
  • Cell-Based Therapies (ATMPs)
  • Medical Devices

Bioanalytics

  • Quick method development / method transfer for small molecules, peptides, proteins (including antibodies)
  • Most appropriate techniques (LC-MS/MS, HPLC-UV, ELISA, Triple quad, Ion-trap, Flow-cytometry, Luminex, FACS, RIA, Radiometry: 14C, 3H, 125I, 32P, liquid scintillation and γ-counters, TopCount and online LC radioactivity detectors)
  • Method validation according to latest FDA, EMA and ICH guidelines
  • Stability testing in formulation and different matrices
  • Bioanalytical support of both clinical and non-clinical studies

ADME/PK

  • Pharmacokinetic and bioavailability studies in rodents, non-rodents andhumans
  • Tissue-distribution, protein-binding and excretion balance studies
  • Toxicokinetics in toxicity and safety pharmacology studies
  • In vitro and in vivo metabolism studies with profiling and metabolite identification
  • Biopharmaceutical assessment (pre-formulation and formulation studies)
  • PK, TK and statistical evaluation with acknowledged and validated tools
  • First-in-man dose prediction
  • Dosimetry calculation for human metabolism study

Preclinical Safety and Toxicology

  • Identification of the Most Human-Like Species
  •      In Vitro Metabolism
  •      Tissue Cross-Reactivity (TCR)
  • General Toxicity
  •      Genotoxicity (in vitro and in vivo)
  •      Single-Dose Toxicity / Dose-Range Finding (DRF)
  •      Repeated Dose Toxicity
  •      Safety Pharmacology
  • Particular Toxicity Testing
  •      Immunotoxicity
  •      Hepatotoxicity
  •      Phototoxicity
  •      Local Tolerance and Irritation
  •      Reproductive Toxicity
  •      Juvenile Studies
  •      Carcinogenicity
  •      Drug-Drug Interaction (DDI)
  •      Impurities Testing

Approvals, Certificates, Authorisations

  • GMP
  • GLP

You might be also interested in

Sourcing this company's services?

Send inquiry anonymously »

Or add this Company to
Sourcing cart