Creative Diagnostics offers the Pharmacokinetics ELISA Kits for the quantitation of serum protein drug levels to provide accurate pharmacokinetic (PK) data that will guide the optimization of drug dosing regimens. Each of our kit goes through fit-for-purpose validation and stability testing to ensure high accuracy, sensitivity and specificity.
Pharmacokinetics ELISA Kits:
Pharmacokinetic (PK) analyses are essential components of the drug discovery and development process. Particularly in early clinical trials, it is of great importance to study PK to serve itself as an “auxiliary biomarker”, helpful for the selection of doses in further trials and promotion of clinical rational drug use. Traditional PK models including compartment models and Michaelis –Menten (M –M) model were widely used in the PK analyses of various drugs, especially in small-molecule drugs. They provided a convenient way to character drugs' properties with model parameters, such as half-life (T1/2), maximum concentration (Cmax), area under the concentration –time curve (AUC), clearance (CL), and so on. However, much more complex PK properties were showed by mAbs compared to those typically associated with small-molecule drugs, and traditional PK models failed to well describe the complex PK process of mAbs. For instance, complex nonlinear PK was encountered frequently by mAbs. The drug exposure or responses did not proportionally vary with dose increasing, and PK parameters such as CL and apparent volume of distribution (V) were not constant in different dosage. Moreover, PK parameters derived from a compartment model fitting and/or an M –M model fitting were significantly varied among patients, in the case they were hard to provide useful information for personalized medicine. For this reason, some new models have been proposed to fit the nonlinear PK of mAbs in recent years.
Monoclonal antibody drugs exhibits much more complex PK properties probably due to significant differences from small-molecule drugs not only in their pharmacological mechanism of action but also in their elimination mechanism. Compared to small-molecule drugs, renal elimination is relatively unimportant for mAbs, as its large size prevents efficient filtration through the glomerulus. Specific to its targets such as antigen, receptor, and some protein or polypeptide, mAbs will encounter a target-mediated endocytosis as most kinds of endogenous IgG. Moreover, a phagocytosis of lymphocyte and even some incompletely explained pathways further complicate the elimination of mAbs.