Pharmacokinetics and Toxicokinetics (PK/TK)
Kinesis Pharma has a long history of performing non-clinical pharmacokinetic and toxicokinetic analysis of bioanalytical data obtained from nonclinical studies in accordance with Good Laboratory Practice (GLP) procedures. Kinesis Pharma participates in the GLP compliance program of the Dutch monitoring authorities, and is accredited to claim GLP for non-clinical PK and TK evaluations (since 2003). The Kinesis data analysts routinely participate as Principal Investigator in multi-site (GLP) studies and make use of validated software. In 2013 the Phoenix WinNonLin version 6.2.1 was validated and is now used for all studies to be analyzed.
Assured quality within non-clinical PK/TK studies
The involvement of the Kinesis QA department in studies is significant. For nonclinical GLP studies all critical phases such as the study plan, study procedures, raw data and the final report are audited. Furthermore, all studies are performed by competent and qualified staff, according to standard operating procedures (SOPs) using validated software. Additionally, all data and calculations are checked by an independent reviewer, before the final report is peer reviewed internally and subsequently audited by QA. Also non-GLP studies are performed according to the high internal quality standards.
The nonclinical department has gained extensive experience and expertise over many years in working according to the OECD GLP guidelines, particularly those concerning multi-site studies, in collaboration with various test facilities and test sites from all over the world. The combination of specific scientific knowledge on pharmacokinetics and toxicokinetics and the constant pursuit of quality excellence make Kinesis Pharma a good choice for the outsourcing of nonclinical PK/TK studies.
When Kinesis Pharma is responsible for the nonclinical pharmacokinetic / toxicokinetic analysis of study data within a project, it is assured that data within the same project are evaluated and reported in the same consistent way and that knowledge is built at Kinesis during data evaluation of different studies within such project. In addition, when the step is taken towards the clinical PK data, Kinesis Pharma already has internal knowledge on the ins and outs of the pharmacokinetic characteristics. A sponsor will surely benefit from this!