How Pharmacokinetic Studies Can Improve Drug Safety and Efficacy?

Today the time and cost required to bring new drug products have continued to increase. However, this increase in difficulties is complemented by the decline in new drug approvals. Therefore, the drug development industry is continuously exploring initiatives to maximize the ROI and improve the success rates of drug development studies. 

Identifying inefficient compounds early during the drug discovery phase is an ideal method to reduce drug attrition rates. Hence understanding the root causes of drug failure can help reduce the overall drug development cost. Pharmacokinetics is one major factor concerned with poor drug safety and efficacy data. Therefore, the current article discusses the importance of pharmacokinetic studies for improving drug safety and efficacy. 

How Pharmacokinetics Assay Improves Drug Safety and Efficacy?

Today scientists have different PK assays, such as Meso Scale Discovery assay, for analyzing PK samples in clinical trials. These robust PK assays help researchers identify inappropriate pharmacokinetic characteristics such as poor absorption, low bioavailability, short elimination half-life, and excessive variability. Such evaluations have made pharmacokinetic input a crucial  drug discovery and development components. 

Today pharmacokinetic CROs have several advanced tools for predicting drug absorption, drug-drug interaction, drug clearance, and transitioning from animal to human PK analysis in clinical trials. This preliminary consideration of PK parameters has reduced the drug attrition rates in Discovery studies. Besides, evaluating pharmacokinetic parameters has further increased our understanding of drug safety and efficacy. 

Drug safety and efficacy can be partially evaluated by extending PK parameter studies to include pharmacodynamic data. Combining drug safety and efficacy data with pharmacodynamic studies instills confidence in the safety and rationality of new drug compounds. Besides, researchers employ an alternative strategy of considering the required drug exposure concerning undesired and desired pharmacological effects to quantify drug safety and efficacy. 

Pharmacogenetics is increasingly becoming a novel technique for assessing drug safety and efficacy. This field of science uses biological markers such as protein, DNA, or RNA to predict drug efficacy and the likelihood of adverse reactions in individual patients. Such targeted approaches help develop therapeutics for specific populations with reduced adverse effects. Enzymes can be polymorphic and may metabolize the drug compound. Hence pharmacokinetic CROs screen for compounds that are substrates for a polymorphic enzyme. This approach helps prevent inter-subject variability in drug exposure and improves drug safety and efficacy. 

Today, it is evident that a robust pharmacokinetic profile can prove extremely crucial for assessing drug safety and efficacy. Generally, PK data is predicted using in vitro and in Vivo preclinical pharmacokinetic evaluations. However, there can be cases where in vitro and in vivo data generated is incomplete. Here pharmacokinetic CROs employ an alternative series of experiments to understand pharmacokinetic properties or, in other cases, may progress to human studies to understand PK properties in humans. 

Human micro dosing is one approach that allows assessing PK parameters in human studies. This approach involves assessing drug exposure in humans at extremely low single doses of a drug product. In conclusion, pharmacokinetic studies are  key to reducing overall drug development costs and assessing drug safety and efficacy.