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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
Understand
• 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

Learn
• 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

Gain
• 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


€2496


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

Address

Berlin, Germany

Online Registration.

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For More Details/ Queries

:+44 2032 398083


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