Key areas of activity
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Key areas of activity

  • development of study design
  • development and validation of analytical procedures for assay of drug substances and their metabolites in biological samples
  • analysis of samples obtained during the clinical part of the study including incurred samples reanalysis;
  • calculation of pharmacokinetic parameters, assessment of bioequivalence
  • statistical analysis of data and preparation of reports about performed studies
  • development of bioequivalence study protocols

Ample opportunities for performance of bioanalytical studies are provided by:

  • high-technology instrumental basis
  • experienced team

Validation of bioanalytical procedures is performed in accordance with the requirements of international and Russian regulatory documents. Full validation of analytical procedure includes the following tests:

  • selectivity;
  • evaluation of lower limit of quantitation, LLOQ;
  • linearity;
  • accuracy;
  • precision;
  • carry-over effect;
  • matrix effect;
  • recovery;
  • dilution integrity;
  • evaluation of minimal values of analyte and internal standard (IS) response;
  • stability;
  • back-conversion of metabolites, if applicable.

Quinta-Analytica Yaroslavl Laboratory uses a wide range of bioanalytical procedures, which were extensively tested in practice of bioequivalence studies.

"Quinta Analytica Yaroslavl" LLC

Bioequivalence studies, phase I clinical trials, validation of bioanalytical techniques, pharmacokinetic calculations, statistical analysis, consulting services

Contacts

Address:
52G Leningradskiy Prospekt, Yaroslavl 150045

E-mail:
info@qayar.ru

Phone:
8 (4852) 58-09-90

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