Testing laboratory evaluation of medicine product quality

Pharmacokinetics and bioequivalence

We perform evaluation of bioavailability and bioequivalence of pharmaceutical drugs along with de-velopment of pharmacokinetic profiles and statistic analysis of data based on testing pre-clinical and clinical studies samples.

Bioequivalence is conformity degree of pharmacokinetic parameters of generic and innovator drugs. Its testing for generics is one of the most important stages in the process of drug registration.

Фармакинетика и биоэквивалентность

We offer performance of bioanalytical part of clinical trials, i.e. pharmacokinetics study, in vivo.

Cycle of clinical trials is performed in order to perform bioequivalence in the course of which a group of volunteers is administered test drug and reference drug under monitor of medical staff. Then subject to any procedure approved within the frames of clinical studies biological samples (blood, urine, etc.) are taken from volunteers and the material is transferred to bioanalytical laboratory for test.

We also provide development and validation of bioanalytical method for determination of new pharmaceutical drugs (HPLC, GS, UHP-LCMS/MS, IR, IR-Ft, UV methods, etc.) in very different biological matrices. 

 

Archive of laboratory is equipped as per GLP requirements:

  • Temperature for storage of deeply frozen samples — -96°C
  • Regular control of temperature parameters along with independent alerting system on failures which uses mobile communication for instantaneous transmission of alarms.

 

Main part of bioanalytical tests is performed using liquid chromatography mass spectrophotometer Shimadzu LCMS-8040 triple quad. In order to perform tests we use modern highly-precise analytical instruments of world leading manufacturers such as Mettler Toledo, Thermo Scientific, Sanyo, etc. It significantly allows increasing accuracy and sensitivity of bioanalytical test, minimizing effect of adverse effects and substantial reducing of study duration.

All bioanalytical methods pass validation as per the requirements of US FDA/EMEA/CHMP/EWP and Ministry of Health and Social Development of Russian Federation. Accuracy and reproducibility of methods is provided using modern methods of analysis of biological objects, high-grade equipment, internal audit and compliance with in-house standards of Quality Management System. 

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