We are testing drug release in a fast and reliable way by using in vitro release testing (IVRT) based on vertical diffusion cells and synthetic membranes.
Drug release of the active pharmaceutical ingredient (API) from its formulation strongly depends on the composition of the drug product. We use IVRT for formulation optimization, quality control, generic drug approval and to prove product sameness after postapproval changes.
Development of new IVRT methods for e.g. diclofenac, acyclovir
Adaptation of existing IVRT methods
Validation of IVRT methods according to EMA and FDA guidelines
IVRT experiments and product testing according to GLP guidelines
Development of analytical methods
Validation of analytical methods according to ICH guidelines
Sample analysis, clinical data management and statistical evaluation according to GLP guidelines