Applying Bioavailability and Bioequivalence (BABE) Guidelines

Date posted 27 July 2020

Event date: 27-28 August 2020

An important workshop for those working in both innovator and generic companies. This ARCS Australia workshop aims to enable attendees to gain an understanding of basic concepts of pharmacokinetics and develop the ability to critically review and provide justification to support the BABE data presented in submissions.

With a focus on oral formulations, the topics to be covered include:

  • Basic principles of pharmacokinetics and bioavailability
  • Understanding the various BABE study designs and how they relate to product types
  • Analytical validation
  • Statistical evaluation
  • Understanding of the regulatory requirements pertaining to BABE studies in Australia and how these compare to other key jurisdictions
  • BABE study test product batch and strength considerations
  • Preparing justifications for the absence of BABE data
  • Common deficiencies in BABE study reports and results

Event details

Date: 27-28 August 2020

Where: ARCS Virtual Classroom

Registration Price: Non Member – AU $ 2275; Member – AU $1415 ; Early Bird – AU $ 1760 (before 30 July)

Registrations close: 24 August 2020

Find out more and register

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