PK/PD assays integrate pharmacokinetic and pharmacodynamic data to fast-track drug development and reduce attrition rates. The current article discusses the importance of PK/PD models for optimizing drug discovery and development.
PK/PD assays to accelerate drug discovery and development
Like complex assessments, such as multiplex cytokine analysis, PK/PD evaluation requires robust systems. Hence, effective PK/PD modeling during drug development needs insights from diverse scientific experts in complementary departments of the pharmaceutical and biomedical industries. Pharmacokinetics/pharmacodynamic modeling employs mathematical and statistical approaches to improve the study design and help make better-guided decisions at each drug discovery and development stage.
The pharmacodynamic part of PK/PD valuations is often performed in a pharmacology laboratory by experts in a given disease area. On the other hand, PK data analysis is performed by DMPK laboratories. In some scenarios, researchers don’t even determine pharmacokinetic evaluations in the same animal utilized in pharmacodynamic studies. Rather, the pharmacokinetic and pharmacodynamic data sets might be developed independently. Moreover, these data points would have been generated in separate time frames and in distinct laboratories. When these data sets are generated at different time frames, it often happens in isolation, and researchers face difficulties while evaluating these results.
Ideally, PK/PD analysis is designed and performed by pharmacological experts and DMPK scientists to generate interpretations and conclusions with insights from other applicable stakeholders, such as mathematical and formulation modeling experts. Hence, the resulting data integrates all relevant information and addresses the question or hypothesis asked in a study model. Moreover, the generated data captures assumptions made during analysis and subsequent evaluation that will rightly reflect the responsibility and ownership of all associated parties.
The pharmacological audit trail is a framework to help make rational decisions during drug development. Integrating PK/PD data with this framework gives a codified tool with a series of biomarker-based questions that should be addressed sequentially at appropriate drug discovery and development stages. Addressing and resolving these issues will decrease the likelihood of drug failure. The pharmacological audit trail framework addresses all aspects of a bioanalytical process, including identifying the patient population that will likely respond to a therapeutic intervention, developing biomarkers for therapeutic response, understanding resistance and its mechanism, and establishing a system to overcome resistance.
Conclusion
The primary objective of early drug discovery and development is to identify promising compounds and determine effective and safe doses. Fulfilling this objective requires an in-depth understanding of the drug molecule and the mode of administration. Integrating PK/PD analysis in drug development can help identify compounds and guide them through efficient clinical drug development phases.
