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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

Clinical Trials and Bioanalyses

 

Bioanalyses

Extent of provided services:

  • Development and validation of bioanalytical methods in different biological matrices
  • Complete bioequivalence study in human and/or animals
  • Pharmacokinetic/toxicokinetic study in human and/or animals
  • Analysis of drugs and metabolites in different biological matrices
  • Identification of metabolite chemical structures

Bioanalytical methods are developed and validated in accordance with the GLP rules and guidelines of ICH/FDA and EMA. The current list of validated bioanalytical methods contains more than 100 items.

Most activities of the bioanalytic department, in cooperation with the Clinical Department, are concentrated on a complete bioequivalence study (complete biopackage includes clinical/non-clinical, analytical, pharmacokinetic and statistical evaluation parts

Quinta-Analytica has successfully performed more than 300 biostudies since its foundation; most of which include pharmacokinetic and statistical evaluations. These analyses have been carried out for pharmaceutical companies in Europe, USA, India and Australia in compliance with international rules and regulations.

The Bioanalytical Department has a disposition of experienced analysts and laboratory personnel. The LC/MS laboratory is equipped with six high-technology Triple-Stage Quadrupole LC/MS/MS instruments. Depending on the complexity of the analyses, the capacity of the bioanalytical department enables the performance of up to 1500 analyses of biological samples per day

In addition to its own company’s Clinical Department, the Bioanalytical Department cooperates with many other clinics, which are involved in Phase I clinical studies. Highly trained and experienced staff are also involved in the determination of the metabolite chemical structure and their isolation from biological matrices.

The new scope of the bioanalytical department is the analysis of diagnostic biomarkers.