Harnessing PK Analysis Data In Early Covid-19 Bioanalysis Studies

Amidst the ongoing Covid-19 pandemic, several approved and potential drug candidates have been repurposed to test their safety and efficacy to be employed in the Covid-19 treatment regimen. The preliminary selection of these potent drug candidates was preliminary based on their in vitro potency. However, the unfavorable pharmacokinetics (in vivo studies) proved to be challenging for their clinical translation efficacies.

Accurate collection of the pharmacokinetic testing data and the supplementary pharmacodynamics characteristics have become the need of the hour. Thus, extrapolating PK data from remaining clinical situations is in constant requirement of the specific precautionary measures due to varying degrees of the physio-pathological conditions.

Both the drug research and development processes require reliable supporting facts from pharmacokinetic as well as pharmacodynamic assays. This enables the PK analysis researchers to arrive at a timely decision regarding the critical parameters. These critical parameters are inclusive of the starting drug dose involved in the first clinical trials and the dosing time evaluation of a pharmaceutical compound in plasma.

Popular approaches relying on PK-PD pharmaceutical drug modeling has often proved its efficacy in handling sparse data derived from different sources. Further, the covariates involved in the Pk sample analysis effectively identify both the pharmacokinetics and pharmacodynamic parameters. Both the population-Pk analysis and PK-PD models have successfully justified their applicability in the infectious disease area, thereby supplementing mankind with a variable tool to explore and predict effective dosing regimens.

Pharmacokinetic studies in patients is employed for the retrospective detection of those various subpopulations wherein the pharmaceutical drug candidate behaves differently. This estimation is usually achieved by co-relating the Pk study data with other available covariate information related to age, smoking status, body weight, disease state, gender, and/or genomic data.

Pk analysis helps analyze a pharmaceutical drug in patients within the initial phases of drug discovery and development. This is when the adverse events associated with the pharmaceutical substances and their metabolites result in possessing safety risks for justifying their reason for the administration to healthy volunteers. Such studies are usually performed in those candidates who suffer from the disease the pharmaceutical drug candidate in trials is intended to treat.

Available PK-PD, cro services and PK assay studies, however, suffer from several limitations, which in turn, contribute to unpredictable conditions. These unpredictable conditions are especially related to dosing optimization studies. Even at this point in the ongoing critical medical emergency, the world still lacks high-quality evidence for supporting the applicability of the repurposed pharmaceutical drugs for Covid-19 treatment. Therefore, the world needs to re-direct its focus on implementing the well-designed pharmacokinetics services to obtain relevant PK and PD data. This specifically targeted data is a pre-requisite for increasing the comprehension regarding the dose-exposure relationships for the repurposed pharmaceutical candidates put into clinical trials. Without establishing a thorough grip over this PK study data, it becomes irrelevant to evaluate and develop an effective dosing regimen.

Thus, no matter whether it is the ongoing Covid-19 pandemic or any other medical emergency, pharmaceutical companies should strictly rely on the pk analysis data for arriving at a final conclusion regarding drug efficacy and reliability.