Pre-clinical biocompatibility testing of peritoneal dialysis solutions.
Pre-clinical biocompatibility testing of peritoneal dialysis (PD) solutions has become an integral part of new solution development. The construction of a pre-clinical screening program for solution biocompatibility should take a hierarchical approach, starting with in vitro cell viability and function assays. The selection of cell types and assay systems for the in vitro studies should be broad enough to permit a balanced interpretation. Whenever possible, animal models are recommended for the next hierarchical level of testing, followed by human ex vivo study designs. Designs of the latter sort provide evidence that a new solution formulation is exerting an altered biological response in vivo; the response is not purely an in vitro artifact or restricted to a given animal species. This article discusses the various approaches available for biocompatibility testing during the pre-clinical phase of solution development, with an emphasis on the advantages and drawbacks of each method.
Holmes
C J
CJ
Renal Division, Baxter Healthcare Corporation, McGaw Park, Illinois 60085, USA. holmesc@baxter.com
D000818:Animals; D002478:Cells, Cultured; D015314:Dialysis Solutions / Q000737:chemistry / Q000633:toxicity; D006801:Humans; D008422:Materials Testing; D010530:Peritoneal Dialysis; D010537:Peritoneum / Q000187:drug effects
D015314:Dialysis Solutions