Biocytogen provides high-quality pharmacokinetic services or PK studies that include:
- Dose range finding
- Drug administration by any route (iv, ip, sc, po, it, im)
- Sample collections over specified time points from blood/plasma/serum and any other tissues
- Blood and tissue-specific PK analysis for biotherapeutics where detection antibodies are available
- Biodistribution including tissue collection and drug concentration determination of biotherapeutics where detection antibodies are available
PK Studies Analysis of Anti-human CTLA-4 Antibody
PK Studies workflow
PK studies analysis of an anti-human CTLA4 antibody in MC38-bearing B-hCTLA4 mice, where the extracellular domain of human CD40 replaces that of mouse CD40 via genomic knock-in. Anti-human CTLA4 antibody was administered i.v. at 0.1, 0.3, 1, 3 mg/kg. Plasma antibody concentrations were determined by ELISA (A) and PK parameters were derived by the non-compartmental model with Phoenix Winnolin 8.0. AUC0-∞ showed dose linearity (B) while half time (T1/2) was unchanged across the doses administered.
|Group||T1/2 (h)||Cmax (ng/mL)||AUC0-576h (h*ng/mL)||AUC0-∞||Vd (mL/kg)||Cl (mL/h/kg)|
|G1(CTLA4 mAb 0.1 mg/kg)||73||469||33563||39581||260||3|
|G1(CTLA4 mAb 0.3 mg/kg)||60||587||72898||83861||313||4|
|G1(CTLA4 mAb 1.0 mg/kg)||43||15717||774191||835554||76||1|
|G1(CTLA4 mAb 3.0 mg/kg)||95||61189||3330696||4513387||103||1|
PK studies analysis results of anti-human CTLA4 in MC38-bearing B-hCTLA4 mice. Data was fitted by the non-compartmental model with Phoenix Winnolin 8.0.