QPS Holdings has completed a 24-bed annex to its phase I clinic at the University Medical Center Groningen in the Netherlands, bringing to 58 its bed capacity for the conduct of first-in-man and early-phase research on novel and complex therapeutic agents.
The expansion was prompted by rising demand for QPS to conduct a greater diversity of large, complex phase I studies, including single- and multiple-ascending dose trials following allometric (first) dose selection to define maximum tolerated doses in first-in-man exposures; PK/PD modeling studies to define the pharmacokinetic and metabolic characteristics of new chemical entities and biologicals; 14C mass balance trials with analysis of both "hot" and "cold" species in the on-site bioanalytical and 14C radionuclide laboratories; food-effect studies, alone or combined with single-ascending dose trials; BA/BE studies for formulation development, generic comparison or pivotal confirmation of a final formulation; drug-drug interaction trials; in-vitro/in-vivo comparisons (IVIVC); and phase Ib/IIa patient studies using clinical endpoint/proof-of-concept in common therapeutic areas and particularly in early pharmacodynamic profiling of CNS compounds (imaging and continuous CSF sampling), respiratory agents (bronchoprovocation challenge testing) and gynecological products (transvaginal ultrasound).
"In the Netherlands, where regulatory timeframes are fast and reliable for phase I studies, client demand is growing. For tight schedules, the Netherlands CTA approval timelines of 14 days are very attractive," said Dr. Wim Tamminga, division director, clinical pharmacology for QPS Netherlands.
QPS also offers IND and NDA program partnering. It employs more than 900 at 10 sites in nine countries on four continents.