Pharmacokinetics (PK) and pharmacodynamics (PD) are important components of pharmacology. Pharmacokinetics (PK) mainly studies the dynamic changes of the body’s effects on drugs, including the process of drug absorption, distribution, metabolism, and excretion in the body, especially the changes in blood drug concentration over time. As for pharmacodynamics (PD), it is the effect of the drug dosage on the efficacy and the effect of the drug on clinical diseases.
The PK and PD of large molecule/biologic drugs utilize the ligand-binding assay (LBA) method to quantitatively determine the biological drugs in animal/human body fluids or tissues (i.e. monoclonal antibodies, peptides, fusion proteins, recombinant proteins, bispecific antibodies, etc.) and the concentration of drug soluble targets.
For PK and PD bioanalytical methods that support pre-clinical and clinical research, method verification (MV) needs to be carried out in compliance with current GLP regulations and guidance. The accuracy/precision, selectivity/matrix effect, dilution linearity and hook effect, parallelism, specificity, stability, etc. need to be evaluated.
- Ipilimumab (CTLA-4), Conbercept, ranibizumab, ramucirumab, Atezolimab (PD-L1), Pertuzumab, Cetuximab Erbitux (Cetuximab), CD40 antibody, SOST antibody, IgE antibody, MCF antibody, PCSK9 antibody, IL-6 antibody, IL-17A antibody, IL-23 antibody, etc.
- EqCAM/CD3, CD3/Her2, PDL1/TGF-β, PDL1/VEGF, (nanobody 1), EGFR/IL-10,CTLA-4/PD1, Her2/Her2