Pharmacokinetics and Bioequivalence

Pharmacokinetics and Bioequivalence

BLIRT Analytical Department offers bioanalytical services in qualitative and quantitative determination of drugs in biological samples, such as biological fluids (blood, serum, plasma, saliva, urine) or tissues. Analyses are performed using ultrahigh performance liquid chromatography coupled with tandem mass spectrometry (UHPLC-MS/MS).

These determinations can be particularly helpful in pharmacokinetic or bioequivalence studies of pharmacological preparations which are necessary in the registration process of generic medicines. The Analytical Department provides services such as the determination of pharmacokinetic parameters, including: elimination rate constant (Ka), maximum drug concentration and time of its occurrence (Cmax, tmax), area under the concentration-time curve (AUC), average residence time of the drug in the body (MRT), volume of distribution (Vd), biological half-life (t0.5), elimination rate constant (Kel), clearance (Cl) and others.

Analyses meet the requirements of the relevant regulatory agencies responsible for the registration of drugs. Research reports with statistical treatment of the obtained results are prepared using certified software. Analytical Department offers calculation of the pharmacokinetic parameters of drugs for all routes of application, regardless of the dosing regimen:

  • independent of the model calculations,
  • compartmental models,
  • modeling consistent with the theory of statistical moments,
  • modeling parameters of PK / PD.

The offer includes a full bioanalysis in accordance with the GLP requirements:

  • development of methods for the determination of the drug obtained in biological material,
  • bioanalytical method validation according to EMA or FDA guidelines,
  • sample preparation (including pre-treatment in place of volunteers, if needed),
  • the appropriate marking (usually with the use of copyright methods),
  • development of an analytical report, in accordance with international laboratory standards and the needs of the customer.

The substantive development of the study includes:

  • calculations and pharmacokinetic analysis (WinNonlin),
  • development of a complete final report including a general section, clinical, analytical, pharmacokinetic and statistical requirements in CTD format (Module5).

The offer may be supplemented with a consultation on:

  • the design of clinical medicine including an analysis of the pharmacokinetics, bioavailability and bioequivalence,
  • a preparation of the proper documentation for the registration of medicines.