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Bioequivalence, Dissolution & IVIVC

  • 07/11/2018 - 09/11/2018
  • Athens, Greece

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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

key takeaways

Understand

  • How to design a bioequivalence study

  • The statistical design needed to getregulatory approval

  • The role of dissolution studies inscreening formulations and as a regulatory requirement

  • In vivo-In vitro correlation:connecting the dissolution data to pharmacokinetics

Learn

  • About the predictive power of pilotstudies and fed state
  • How to develop dissolution tests andhow to interpret them

  • About the use of dissolution studies toobtain biowaivers

Gain

  • An understanding of the relationship between formulation and bioavailability
  • A fundamental knowledge of drug absorption and its effect on dissolution and pharmacokinetics
  • An appreciation of what to look forwhen auditing a biostudy house in terms of validation

  • Project management skills in terms oftiming and planning of biostudies

training features

Interactive way of lecturing through stimulation of discussions

Individual case by case consultancy with the trainers

Comprehensive printed and digital course documentation

8h+ of networking with other industry experts

Case studies from the trainer's experience

Certificate of Completion issued by trainers

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Athens is the capital of Greece. It was also at the heart of Ancient Greece, a powerful civilization and empire. The city is still dominated by 5th-century BC landmarks, including the Acropolis, a hilltop citadel topped with ancient buildings like the colonnaded Parthenon temple.

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