Pharmacokinetics (PK-PDrugs)

Ultra High Resolution Liquid Chromatography and Mass Spectrometry

The Xevo TQD® (Waters, Massachusetts, USA) ultra-high resolution liquid chromatography equipment connected to a triple quadrupole tandem mass spectrometry detector provides us with the maximum sensitivity, specificity and analytical versatility for the determination of drugs. and metabolites. It is the reference technique for the determination of most chemical substances. The equipment allows the interpretation of the data obtained, mainly the mass spectra and the chemical structure of the molecules that are analyzed.

On the other hand, ultra-high resolution liquid chromatography equipment is also available with photodiode detectors that cover the UV/Vis spectrum and fluorescence, and with radioactivity detectors.

Biological drug and immunogenicity analyzer

Biological drug monitoring offers key information on exposure and immunogenicity in patients who are prescribed these biological therapies, widely used for the treatment of chronic inflammatory diseases, oncological processes, etc.

In addition, we have the Promonitor Quick device (PQ Reader), a portable and compact device that allows instant quantification of these biological therapies.

Immunoassay system

The Alinity ci-series, a compact immunoassay system, provides fast, reproducible results thanks to proven CHEMIFLEX chemiluminescent detection technology. It offers a wide variety of assays, as well as being able to work with different matrices (whole blood, plasma, serum, cerebrospinal fluid, etc.) and can perform up to 1,550 determinations per hour.

The unit (PK-PDrugs) coordinated from the Research and Innovation Unit of the Pharmacy Service of Santiago de Compostela, is committed to the most sophisticated analytical technologies focused on the determination of drugs and metabolites in the different fields of biomedical research.

CLINICAL RESEARCH

Determination of drugs and metabolites in biological matrices: To be able to carry out determinations in all types of biological matrices (blood, plasma, serum, urine, bile, ascitic fluid, cerebrospinal fluid…) and pharmaceutical forms (solutions, suspensions, eye drops, etc.). We have the necessary pre-analytical equipment with vacuum evaporators, nitrogen systems and solid extraction phase cartridges. In addition, ultra-low temperature freezers are available that guarantee the safe storage of the preparations, as well as the setting of the highest safety standards for the user, as they are in accordance with DIN 58375 and Medical Devices according to MDR (EU) 2017/745, Class IIa. or 21CFR Part 864.9700, Class II.

Clinical pharmacokinetic studies: In addition to the plasma determination of drugs, a fundamental added value is offered, such as pharmacokinetic and pharmacodynamic (PK/PD) analysis as a precision medicine tool at a clinical level, and this service can also be complemented with advice and performance of pharmacogenetic studies. Population pharmacokinetic (popPK) studies are already a fundamental pillar in all stages of development, both preclinical, clinical and post-marketing of a drug. The PK/PD drugs platform will offer the development of population pharmacokinetic and pharmacodynamic models and their subsequent implementation in interactive web applications (R, shiny) that allow the end user to work and carry out simulations in a much more user-friendly interface.

DEVELOPMENT AND CHARACTERIZATION OF MEDICINES

Biopharmaceutical characterization of new formulations in development: The concepts of bioavailability and bioequivalence are closely related to pharmaceutical development and particularly to the manufacturing procedures of pharmaceutical forms. The platform has the capacity to carry out analytical determinations of drugs included in new formulations under development, with studies of release, absorption, distribution, metabolism and excretion both in vitro and in vivo. Likewise, there is a radiopharmacy unit for the radiolabeling of compounds and pharmacokinetic monitoring with molecular imaging equipment.

Drug stability studies: We have clean rooms for the preparation of drugs that require the strictest conditions of sterility. In addition, there is specific equipment for carrying out drug stability studies and Memmert climatic chambers that allow temperatures and humidity to be maintained with excellent homogeneity, essential to comply with ICH – WHO – EMA – ASEAN – GMP – GLP specifications and GCCP.

Fees are available here.

VAT not included.