Our expert staff have the competence to creatively address real stake holders value through advanced analytics. Our analytical expertise in providing a complete data package for ” In-Vitro Bioequivalence Establishment ” that serves as a surrogate for the Clinical End Point study need is sought by our partners to waive the need of a clinical study for Bio-equivalence.

Services

• Q1 /Q2 Sameness (Qualitative and Quantitative composition similarity and sameness)
• Q3 Similarity (Micro-structural similarity and sameness) addressing :

  1. Particle size
  2. Globule Size
  3. Rheology
  4. Thixotropy
  5. Viscosity
  6. Yield stress
  7. Porosity
  8. Statistical inference
  9. Dissolution rates
  10. Release rates
  11. Permeation rates
  12. Crystal habits
  13. Insoluble & soluble fractions.
  14. physicochemical characteristics.

 

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