|
Pharmacokinetics - Data analysis |
Kinesis has a long history of analyzing drug concentration-time data that derive from all stages of drug development i.e. toxicokinetic studies, first-dose-in-man studies, bioequivalence studies (including bioequivalence statistics), Phase II/III, special populations etc. - Fully trained Data Analysts perform the analysis under supervision of a senior pharmacokineticist
- In-house validated WinNonlin and SAS routines are used for the calculations of the pharmacokinetic parameters (e.g. Cmax, AUC, half-life) and reporting of the data in tables and graphs
- High quality GCP, GLP (including multi-site studies according to OECD guidelines) or GLP based procedures will be followed, depending on the request of the sponsor
- Compartmental analysis or evaluation of pharmacokinetic-pharmacodynamic relationships (PK/PD) is also part of our biometric services
| | | |  |
|
|
|