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In Vitro Release Testing (IVRT)

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.

IVRT

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.

Our Services

  • 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

Services

Bioanalysis

We analyze low volume samples from all biological matrices to determine PK/PD profiles and to support your biomarker research.

Bioequivalence testing

Fast and efficient PK based bioequivalence testing of topical generics.

Biostatistics

We offer a wide range of specialized biostatistical services to manage all aspects of your study from design to data analysis.
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