Analytical assay services are crucial for PK assessments, PD assays, and DMPK profiling of drug products. Analytical assay services play a vital role in characterizing, validating, and documenting study results for all types of biomolecules, including small and large-molecule bioanalysis. They offer PK/PD assays compliant with GLP/GMP requirements and aligned with international regulatory standards such as FDA, ICH, and EMEA. Therefore, the current article discusses how analytical assay services for PK/PD in clinical trials can support drug development.
Importance of PK/PD Modeling
Pharmacokinetics evaluates the effect a body has on a drug product. It does so by assessing the absorption, distribution, metabolism, and excretion properties of a drug. By comprehending the pharmacokinetic properties of a drug in different biological materials, we can understand drug interaction and the duration and intensity of drug efficacy.
On the other hand, pharmacodynamics describes the effect a drug product has on the body. These effects include physiological, molecular, and biochemical effects. Researchers employ numerous assessments such as receptor binding, chemical interactions, and post-receptor effects, to evaluate pharmacodynamic data.
However, PK/PD data together is beneficial to determine the dose/response relationship and design the dose route and schedule of drug administration for generating maximum efficacy while reducing adverse reactions.
How can sponsors benefit from deep and diverse expertise of analytical assay services during PK/PD modeling?
Analytical assay service providers are experienced in generating PK data in multiple study species, including humans, nonhuman primates, and rodents, and in numerous biological matrices such as serum, plasma, saliva, and urine. Besides, they have in-depth knowledge and understanding of factors that could affect data validity, and hence they consider these challenges for delivering optimal assay results.
In addition to detecting monoclonal antibodies, analytical assay services can develop and validate PK assay for different therapeutic proteins having endogenous components. Moreover, they are well-versed in performing PK assessments for comparing original drugs with other biosimilar products.
All PK assessments are compliant with GLP/GMP regulations. Besides, pharmacodynamic assessments are supported by reliable bioanalytical assays such as receptor occupancy assays. Notably, most analytical assay services can function as a central laboratory for clinical studies. These laboratory services can collect samples and isolate and process them to conduct and deliver robust results.
Analytical assay services have multiple optimal platforms at their disposal. These platforms include ELISA, MSD-ECL assay, Gyrolab, luminous, flow cytometry, QPCR, and LC-MS systems. The scientists at analytical assay services can help sponsors select the best technique depending on their projects. They ensure that the platform chosen has both enhanced sensitivity and regulatory compliance. Besides, analytical assay services can develop and validate PK/PD assay throughout different phases of drug development.
Analytical assay services combine multiple robust platforms with a team of seasoned scientists and experts in handling PK/PD complexities. Such a reliable team offers scientific excellence and delivers results on a global scale. Importantly analytical assay services have proven expertise in interpreting PK/PD data and can help sponsors understand the ADME and DMPK properties of the drug product.