Pharmacokinetics-Pharmacodynamics (PK-PD) Modeling: A translational path to brain-targeted drug delivery

Pharmacokinetic-pharmacodynamics (PK/PD) modeling has been recognized as an essential tool for the planning and execution of clinical pharmacology investigations throughout the formulation development process. The utilization of PK/PD modeling to optimize dosage recommendations and therapeutic medication monitoring is on the rise, and PK/PD model-based dose individualization is going to play a crucial role in personalized medicine. In recent years, higher costs and low productivity in drug development have got a lot of attention. Fewer than 10% of innovative medications that survive clinical trials are commercialized, while many more fail in preclinical research. Based on preclinical and clinical data, the FDA now defines model-based drug development as a key tool in the assessment of therapeutic efficacy and safety of medications. As successful drug delivery to central nervous system (CNS) diseases has been a tough challenge, effective use of PK/PD models can permit merging data from clinical trials with quantified exposure and provide highly convincing explanations for disparities in the results of distinct investigations. To improve CNS therapies and drug development, details of inter-species and inter-condition variations are needed to enable target site pharmacokinetics and associated CNS effects between disease states. The present review covers the potential of PK/PD modeling in the current scenario of drug development with a special emphasis on CNS-based targeted delivery. Additionally, challenges associated with the field have also been addressed.