Tissue specific PK and PD studies
As a service to the pharmaceutical industry, we investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of new drugs as well as the bioequivalence (BE) of new pharmaceutical formulations. We also carry out biomarker-based and metabolomic studies to pinpoint the causes of inflammatory diseases. We perform preclinical ex-vivo and in-vivo as well as clinical studies. In these studies we use microdialysis and our patented Open Flow Microperfusion (OFM) method.
Topics addressed in different target tissues
Skin: transport routes and effects of drugs within the dermal layer after topical or systemic administration, e.g. topical glucocorticoids or systemic antibodies in the case of psoriasis. Learn more.
Brain: transport across the blood-brain barrier (BBB), dose-response effects when the BBB is bypassed, monitoring of BBB function, e.g. highly lipophilic substances, psycho- and neuropharmaceuticals. Learn more.
Adipose tissue: transport routes and effects of drugs in adipose tissue, e.g. insulins. Learn more.
In addition to the tissue specific PK/PD studies we also offer accompanying services ranging from the development of research protocols to reporting project results. Our services include:
- developing study designs and research protocols.
- preparing and submitting documents to boards and authorities (e.g. ethics committee).
- developing, implementing and performing GLP compliant PK/PD bioanalysis for OFM samples in our bioanalytical lab.
- developing Source Data Forms and electronic Case Report Forms using OpenClinica(R) according to your database requirements.
- performing comprehensive data management including user training, data cleaning, plausibility checks, outlier handling, query management, data base release meetings, data base lock and archiving.
- developing the statistical analysis plan (including sample size calculation), performing and validating the clinical statistics.