Pharmacokinetic (PK) studies provide understanding of the biotransformation that a substance undergoes when it is introduced into the body during the ADME (Absorption, Distribution, Metabolism and Excretion) process. Valuable data that is generated in various closely related species such as rats, mice or monkeys enables the prediction of metabolism or PK in humans. ChemDiv's animal pharmacology labs provide maximum flexibility in selecting adequate animal platform and study design.
Case study:
Our partners value ChemDiv’s fast PK testing in monkeys (Macaque Rhesus and other species available) where a typical study design includes five animals with a single dose administered by IV, IP or PO at 6-8 time points. Bioanalytical is complete with LS/MS/MS analysis and a final report is supported with WinNonlin 5.2 data.
The data issued from blood samples are used to generate drug and/or metabolite concentration over time curves; urine and tissue samples are used to track the distribution. Basic PK parameters e.g.: AUC, Cmax, tmax, elimination half-life, volume of distribution, clearance, oral bioavailability, - are calculated in quick preliminary and final reports together with fundamental statistics.
All studies are performed in accordance with a Statement of Work (SOW) that is developed jointly with the project sponsor to meet the specific study objectives. Custom designed protocols may be developed with a Study Director.
| 
