CSU "Analytical Spectrometry" provides a range of services to the pharmaceutical and biotechnology industries. We focus on quantitative determination of pharmaceuticals and biomarkers in physiological fluids and tissues (BE, PK, PD, BA, and TDM) in accordance with the most recent regulatory agencies requirements (FDA, EMA) and GCLP principles.
Our services include:
- Biowaiver studies for solid oral dosage forms;
- Clinical trial planning and design based on specific requirements for blood sampling, biosamples transporting and storage;
- Bioanalytical methods for drugs and metabolites development and validation in biological fluids;
- Sample analysis for clinical and non-clinical studies;
- Pharmakinetic and statistical data evaluation using SAS and/or WinNonLin;
- Study results reporting and documenting according to international requirements;
- Samples storage at -20оС and -70оС;
- Safety report and final report development for clinical and pre-clinical studies in accordance with local and international requirements.
The method validation is implemented in compliance with local requirements (Guideline for the Evaluation of Medicinal Products, 2013), FDA and EMA standards and includes the following parameters:
- Method linear range;
- Lower limit of quantification determination;
- Inter- and intra- day accuracy and precision;
- Analyte selectivity; endogenous level determination if required;
- Analytes mutual impact when multi compound mixtures analyzing;
- Analyte and internal standard recoveries;
- Long-term stability in biological fluids;
- Post-preparative stability of analyte;
- Analyte stability in stock and working solutions;
- Short-term stability
- Freeze and thaw stability;
- Matrix effects evaluation with assessment that of hemolyzed samples;
- Carryover effect;
- Dilution integrity.
More than 135 bioanalytical methods for drugs and biomarkers determination were developed in CSU "Analytical Spectrometry". We ensure that our clients receive professional and reliable bioanalytical support with high quality levels and delivery schedules. We use state-of-the-art equipment and the latest techniques to develop highly exacting analytical methods that are validated in accordance with FDA and EMA standarts.
If you have any questions. don`t hesitate to contact us.
Gzhatskaya st.27, office 240