Bioequivalence, Dissolution & Biowaivers 2020

Bioequivalence, Dissolution & Biowaivers Date 16 – 17 March, Location – Berlin, Germany

Course description
A unique training course that integrates the in-vitro dissolution testing, pharmacokinetics and biostudies as related to solid dosage formulations

Key topics

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

Key takeaways
• 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 studies in fasting and fed state
• 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

Registration Fee


Per Participant

About Berlin, Germany

Berlin, Germany’s capital, dates to the 13th century. Reminders of the city’s turbulent 20th-century history include its Holocaust memorial and the Berlin Wall’s graffitied remains.

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Start Time

9:00 am

March 16, 2020

Finish Time

5:00 pm

March 17, 2020


Berlin, Germany

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