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Bioequivalence, Dissolution & IVIVC

14th November - 16th November 2016
Courtyard by Marriot Berlin City Center, Axel Springer Strasse 55, Berlin, Germany

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Key topics

  • Development of dissolution tests and their biomimetic value
  • Prediction of drug substance pharmacokinetics
  • Consideration of pKa and sites of adsorption
  • Design of a biomimetic dissolution test
  • Value of IVIV correlations - regulatory viewpoint
  • Biostudy results vs. statistical requirements
  • Use of dissolution studies to obtain biowaivers
  • Relationship between formulation and bioavailability

Why to attend

  • How to design a bioequivalence study
  • The statistical design needed to get regulatory approval
  • The role of dissolution studies in screening formulations and as a regulatory requirement
  • In vivo-In vitro correlation-connecting the dissolution data to pharmacokinetics
  • About the predictive power of pilot studies
  • The requirements for fed and fasted studies
  • How to develop dissolution tests and how to interpret them
  • About the use of dissolution studies to obtain biowaivers
  • A fundamental knowledge of drug absorption and its effect on dissolution and pharmacokinetics
  • An understanding of the relationship between formulation and bioavailability
  • An appreciation of what to look for when auditing a biostudy house in terms of validation
  • Project management skills in terms of timing and planning of biostudies


Who should attend

Regulatory affairs professionals, Dissolution testing specialists

Pharmacokineticists, IVIVC specialists, BA/BE managers

Formulation managers, Solid dosage formulators

Want to know more?

Learn the full details about the event program in the downloadable agenda.