Our Non-clinical Pharmacokinetics services include:
Toxicokinetics
The primary objective of Toxicokinetics is to describe the systemic exposure achieved in animals and its relationship to dose level and the time course of the toxicity study. In addition, toxicokinetic data can aid design of future studies with respect to dose level and dose regimen. Using toxicokinetic data, we can help interpret the relevance of toxicology findings to humans.
Our Toxicokinetics services include:
- Non-compartmental analysis
- Statistical assessment of dose proportionality
- Assessment of time-invariance and effect of sex
- Input into study design including optimization of PK sampling
Industry standard software used within our Non-Clinical Pharmacokinetics Group include SAS (SAS Institute, Inc.) and WinNonlin Pro (Pharsight Corporation). These applications are validated according with our Computer System Validation procedures and meet the requirements stipulated by regulatory bodies. Our validation documentation is available for review onsite.
Interspecies Scaling
Interspecies Scaling can be used to estimate the pharmacokinetic parameters in man. Predicted PK parameters can be used to determine the first dose in man and associated safety margin, as well as predict oral bioavailability.
Our Interspecies Scaling methods used include:
- Allometric Scaling
- In vitro (human liver) to in vivo
- In vitro assessment of oral bioavailability (Caco-2)
Reports
Our reports are comprehensive and concise with data presentation (tabular and graphical) designed to clearly answer the objectives of the study. An independent audit of the draft report and associated data are routinely performed by our Aptuit Quality Group unless specified otherwise.
Our work is analyzed and reported in accordance with GLP and relevant ICH, EMEA, and FDA guidelines, as appropriate.