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Health

In Vitro Release Tests (IVRT)

IVRT, In vitro release test, diffusion, API,

We test drug release in a fast and reliable way using IVRT based on vertical diffusion cells and synthetic membranes.

IVRT, In vitro release test, diffusion, API,

The release of an active pharmaceutical ingredient (API) from its formulation is highly dependent on the composition of the drug. We use IVRT for formulation optimization, quality control, generic drug approval and to demonstrate product equivalence for post-approval 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 trials and product tests according to GLP guidelines
  • Development of analytical methods
  • Validation of analysis methods according to ICH guidelines
  • Sample analysis, clinical data management and statistical evaluation according to GLP guidelines
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