What is PK/PD Analysis

Free Pharmacokinetic Software & Excels used in PK/PD analysis is pharmacokinetics (PK) refers to the process of how drugs move within the body, focusing on what the body does to the drug. It encompasses the stages of absorption, distribution, metabolism, and elimination of the drug within the human body.

PK studies play a crucial role in allowing drug developers to understand how doses (or the effects of other factors such as blood pressure, heart rate, etc.) correlate with the concentrations of drugs in the blood or plasma across different patient populations. Additionally, PK studies aid in identifying the necessity for dose adjustments based on PK variations among demographic subgroups or groups with impaired elimination. These studies also serve as the foundation for therapeutic drug monitoring, especially in rare patient populations, in the management of certain cancers (like methotrexate), or in situations where highly effective drugs with very narrow safe therapeutic ranges are required.

PK can be seamlessly integrated with both Statistics and Programming or utilized as a standalone service, particularly when clients already possess Statistics and Programming support.

please find below Excels and software for PK/PD analysis sample size, ANOVA estimation:

Our expertise extends to collaborating with Bioanalysis labs, which specialize in quantifying drug concentrations from clinical trials. Upon receiving Bioanalytical data, whether in Excel or SAS format, we employ PK software, such as Phoenix WinNonlin, to compute PK parameters.

Our PK Team is adept at working alongside Statistics and Programming departments in external companies, provided they possess such capabilities. Alternatively, we can collaborate with our in-house Statistics and Programming department as necessary, although it may not always be required, especially for rapid interim or ad-hoc analyses.

Pharmacodynamics (PD) analysis enables drug developers to measure the correlation between the dosage of a drug and its pharmacological or toxicological impact on patients. The outcomes of PD investigations are frequently influenced by receptor response, often attributable to the presence of competing drugs targeting the same receptor.