Safe and effective drug discovery and development approaches are critical for bringing promising drug therapy to the patient population. Discovery and development phases are one of the most robust pipelines for pharmaceutical drugs. However, recently many have claimed this process to be efficient. Exploring the parameters of pharmacokinetics as well as pharmacodynamics can prove beneficial in accelerating drug development and bringing safe yet effective products.
Pharmacokinetics (PK) is a crucial element in meeting stringent regulatory requirements. However, earlier development studies did not integrate the PK and PD characteristics of a product. The US FDA mandates PK studies to assess the absorption, distribution, metabolism, and excretion characteristics of a drug product. This guidance further emphasizes safety and toxicokinetic properties rather than focusing on PK/PD relationships.
Meso Scale Pharmacokinetics in drug development
Drug developers have several platforms available for PK bioanalytical assessments, including LC-MS and ELISA. However, Meso Scale Discovery assays based on electrochemiluminescence detection have emerged as a valuable tool in assessing the pharmacokinetics properties of a drug product. Along with the Meso Scale PK assay, the platform has several assay options, such as Meso Scale ADA bridging assay and cytokine assay. However, similar to LC-MS method development, adequate assay development and validation is crucial for generating robust and reliable results.
Meso Scale Discovery assays have numerous assay development kits and materials offering superior performance at every stage of drug development. Moreover, MSD assays have enhanced sensitivity and a broader dynamic range compared to traditional ELISA assays. This technology has the stimulation mechanism decoupled from the generated light signal, and hence it reduces background signals. Moreover, MSD assay reduces free drug interference and matrix effects to improve assay performance and workflow. Such benefits have made the Meso Scale Discovery assay ideal for pharmacokinetic testing. Besides, drug developers are increasingly relying on MSD assay to test immunogenicity drug tolerance and neutralizing capacity and pharmacodynamic studies. Let us now understand the working of the Meso Scale PK assay.
Pharmacokinetics studies drug movement through the body. It evaluates the absorption, distribution, metabolism, and elimination of a drug product, each of which is time-dependent. MSD assay focuses on identifying the effects of the body on the drug product. Pharmacokinetic studies often involve removing the serum at specific intervals after drug exposure. Generally, serum or plasma is the primary choice of the biological matrix to study the pharmacokinetic properties of a drug product.
The following section outlines a typical procedure of Meso Scale PK assay.
- Coat the MSD plate with the target
- Add the blocking reagent and incubate the plate for 1 hour
- Wash the MSD plates
- Add the study sample
- Incubate for 1 hour
- Wash the plates
- Add detection antibodies
- Wash the plate
- Add read buffer
- Read the MSD plate
Today drug development companies have newer strategies, such as population-based PK analysis. PK/PD-based approaches have shown consistent and reliable results. However, population-based PK assessments are proving reliable and more efficient. The primary differences between this individualized population-based therapy and PK/PD-driven drug development are using PK/PD data and incorporating model-building systems early during the preclinical phase.
Must Read: MSD Analysis: Techniques and Advancements in Immunogenicity Assays
