Characterizing a therapeutic’s pharmacokinetics (PK) and pharmacodynamics (PD) begins during nonclinical development and continues throughout clinical development. The methods used to perform clinical PK analyses (for example, noncompartmental analysis) are identical to those used for nonclinical PK analyses, and by extension, toxicokinetic (TK) analyses. The only difference is that nonclinical PK involves doses in the anticipated clinically therapeutic range whereas TK involves higher doses as part of toxicology or safety pharmacology studies.
These analyses generate PK parameters that are useful measures of systemic exposure. The exposures may be correlated with therapeutic or toxic responses and can even be linked with biomarkers that represent PD effects (which, in the case of safety and toxicity are often referred to as toxicodynamic [TD] effects). Determining exposure-response (E-R) and PK/PD relationships are important for early evaluation of the therapeutic index of a new molecular entity (NME) and are important for translation of nonclinical results to predict likely outcomes in humans for first-in-human (FIH) dose selection.
Our experts at Allucent can support the entire range of toxicity studies that are required from early development through clinical development and registration. We provide nonclinical PK, TK, and PD analyses across all types of therapeutics (small to large molecules) and every route of administration. We have experience designing, analyzing, and interpreting PK, TK, and PD data from complex nonclinical study designs, such as immunogenicity and biodistribution data for safety and efficacy evaluation. Whether you need PK, TK, or PD analyses, interpretation of results, translational modeling and simulation of E-R and PK/PD relationships, advice on next steps, or any other nonclinical consulting services, our team will work with you to determine the most appropriate and cost-effective options for your program.