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Bioavailability and Bioequivalence

6 - 7 December 2017

Radisson Blu Edwardian Grafton, London

Bioavailability (BA) is defined as the rate and extent to which the unchanged active substance is absorbed and becomes available in the systemic circulation.  Understanding bioavailability is essential during drug development as it is one of the fundamental properties of drug formulation. Information on bioavailability is also used to determine bioequivalence (BE) when submitting a generic dossier.

Through interactive sessions and multiple case studies this 2-day course will evaluate every aspect of BA/BE from the regulations and types of protocol studies to bioanalysis, statistical analysis and reporting. The course will also examine key aspects of biowaivers such as the regulatory hurdles, types of biowaivers, data needed and the risk associated with submitting a biowaiver.

  • Understand the fundamentals of bioavailability, bioequivalence and biowaivers
  • Determine when a BA/BE study is obligatory
  • Identify the various BA/BE protocol studies that are used
  • Develop strategies for testing highly variable drugs and design studies for different types of formulation
  • Examine bioanalytical method validation and requirements in the US and EU
  • Learn to calculate pharmacokinetic parameters on various types of studies and formulations
  • Assess the regulations in the EU, US, Russia, Brasil, China and Japan for bioequivalence studies to gain a global perspective and maintain compliance
  • Learn to interpret biowaiver regulations in the US and EU and meet compliance
  • Evaluating the risk associated with submitting a biowaiver
  • Examine issues with metabolites, endogenous products, enantiomers, long half-life’s and narrow therapeutic index drugs

This course is designed for professionals working in the following areas:

  • Clinical Drug Development
  • Quality Assurance
  • Regulatory Affairs
  • Project Management
  • Bioanalytics
  • Biostatistics
  • IVIVC
  • R&D

Jean-Michel Cardot is a professor and Head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Universite d’Auvergne, France. His laboratory research fields are dissolution, bioequivalence and IVIVC. His personal research fields are biopharmaceutical development of drugs, in vivo bioequivalence and IVIVC.

To find out more about Jean-Michel Cardot, you can watch 'Meet our Trainers' video featuring Jean-Michel on our YouTube channel by clicking here.


                             Bioavailability and Bioequivalence Course Reviews

"The course itself was extensive and broad. The trainer had an excellent ability to communicate."

Director, Regivet BV

"I chose this course to support my knowledge collected by 'learning by doing' with facts and additional background. The course was very interactive and the trainer had a great amount of knowledge."

Head of Clinical Development & Drug Safety, AOP Orphan Pharmaceuticals

"The bioanalytical part, regulatory tips and in vitro parts are the aspects of the course I enjoyed the most." Project Lead, Tecnimede S.A.

 "This was the only in-depth course on Bioequivalence I could find. The knowledge and experience of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past."

Regulatory Affairs Development Manager, Regivet BV

IVIVC - A Way to Speed up Development Using Dissolution as a Surrogate Tool.

Led by Jean-Michel Cardot, course leader for Practical Solutions for Establishing IVIVC and Bioavailability and Bioequivalence.
In 30 minutes, this webinar explores hot to optimise IVIVC using your dissolution data.

Topics covered:

  • Basis of IVIVC
  • Why IVIVC and dissolution are important
  • Use in development: interest and limitations
  • Optimisation of formulation based on IVIVC
  • Conclusions and Q&A session

The trainer was very experienced with many examples and encouraged time for questions.


Regulatory Affairs International Project Manager, Medac GmbH

The trainer was very knowledgeable and had good presentation skills.

Director, Northumbria Pharma


The knowledge of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past.

Regulatory Affairs Development Manager, Regivet BV


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