Pharmacokinetic and toxicokinetic evaluation.
Kinesis has a long history of performing non-clinical PK and TK evaluations, in accordance with Good Laboratory Practice (GLP) procedures. Kinesis participates in the GLP compliance program of the Dutch monitoring authorities, and is accredited to claim GLP for non-clinical PK and TK evaluations. The Kinesis data analysts routinely participate as Principal Investigator in multi-site (GLP) studies and make use of validated software.
Assured quality within non-clinical PK/TK studies
One of the services offered by the non-clinical development department of Kinesis Pharma is the PK/TK evaluation of bioanalytical data obtained from non-clinical studies. The majority of these studies are performed under GLP.
In this respect, Kinesis has already been inspected several times by the Dutch GLP Inspectorate (Voedsel- en Waren Autoriteit) and, in June 2009, the endorsement of Good Laboratory Practice compliance was obtained for the third consecutive time. This strongly motivates the non-clinical department to continuously monitor and optimize the Kinesis quality system in close collaboration with the quality assurance (QA) department.
The involvement of the Kinesis QA department in studies is significant. For non-clinical GLP studies all critical phases such as the study plan, study procedures, raw data and the final report are audited. Even for non-GLP studies, which are also performed frequently, the Kinesis Pharma QA department is involved in checking the final reports (QC-check). 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 checked by QA.
The non-clinical 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 (non-clinical) knowledge and the constant pursuit of quality excellence make Kinesis Pharma a good choice for the outsourcing of non-clinical PK/TK studies.
Track record PK/TK evaluations
• GLP accreditation since November 2003
• Number of GLP studies since November 2003: > 90
• Number of non-GLP studies: > 100
• Performed ghostwriting of PK/TK and metabolism reports for > 35 studies