An important goal of bioanalysis in the pharmaceutical industry is to study the pharmacokinetics (PK) and pharmacodynamics (PD) of the drug and its metabolites.
We are experts in large molecule bioanalysis and offer bioavailability studies as well as single dose and multiple dose PK studies. We use a wide range of techniques and technology platforms to meet your needs and always work to optimize existing methods to increase efficiency and robustness.
Our agile, flexible team of scientists is continually developing and validating new methods and technologies to meet the ever-changing and increasing demand of our clients.
There is no "one size fits all" approach to biosimilar product development and there are numerous challenges with BIOSIM development and in the online presentation we are looking at some of those considerations with a specific focus on the bioanalytical strategies that are applicable for PK assays.
Pharmacokinetics is the study of what happens to a pharmaceutical in the body from administration through absorption, distribution, metabolism to excretion.
Understanding the bioavailability, exposure, half-life, clearance and metabolism of a drug may be the difference between success and failure in the clinic. PK assays are a vital part of the drug development process and the data derived is used to help select dosage for clinical studies.
We conduct our high-quality PK services strictly in compliance with GCP regulations and in accordance with international regulatory guidelines (FDA, EMEA, ICH).
Furthermore, we perform measurement of drug concentration levels in healthy volunteers and patients as part of pharmacokinetic (PK) investigations for Biologics and Biosimilars in clinical phases. This service is performed on ELISA or the Meso Scale Discovery (MSD) platform.
Pharmacodynamic studies analyze the biochemical and physiological effects of the drug on the patient. Large molecule PD bioanalysis provides insight into the mechanism of action and how the drug works on a biochemical level.
These studies are crucial for the complete understanding of the therapeutic product.
PD bioanalytical studies can be used to investigate what molecules bind, how the targets are inhibited, what signaling pathway is affected and for identifying downstream effects.
We perform measurement of drug concentration levels in healthy volunteers and patients as part of pharmacodynamic (PD) investigations for Biologics and Biosimilars in clinical phases using ELISA or Meso Scale Discovery (MSD).