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  • 04/11/2019 - 06/11/2019
  • 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 absorption

Value of iViV correlations – regulatory viewpoint

Biostudy results vs. statistical requirements

Dissolution testing has been around for some 50 years. During that period we have put a man on the moon, we have made huge advances in computer software and hardware and have moved from vinyl through open reel tapes, cassettes, CD's and mpeg in terms of recording, and yet most dissolution testing is carried out on essentially the same equipment that was introduced into the Pharmaopias back in the '70's.  However the regulatory authorities are demanding more and more data and interpretation of that data derived from equipment that was never intended as anything beyond a relatively crude quality control technique.

It is not surprising therefore that chemists, formulators and regulatory staff are still battling to provide answers to many of the regulatory demands. In order to meet these challenges it is necessary to understand the limitations of the equipment and the dosage form-equipment artifacts that can be created. Unfortunately very often dissolution testing suffers from the classic problem of silo thinking. The analytical chemist (dissolution scientist) looks at the test as a physicochemical process, often not understanding the principles involved in formulating products and the formulator looks at the results as a set of numbers which may or may not satisfy what may appear to be arbitrary requirements of QA or regulatory departments. This is all without even starting on the question as to the relevance or correlation with what is actually happening to the product in the patient.

This course will attempt to tear down the walls of these silos. We will be looking at dissolution from the limitations of the testing procedures, the way different formulations behave in test procedures through to the concepts of pharmacokinetics and the regulatory requirements for submission for marketing authorization.

by Malcolm Ross, President at Generapharm, Switzerland

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

REGISTRATION

Delegate fee

from 2596 € Buy

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Electra Hotel Athens

Electra Hotel Athens

JOIN US IN Athens

Athens is the capital and largest city of Greece. Athens dominates the Attica region and is one of the world's oldest cities, with its recorded history spanning over 3,400 years and its earliest human presence starting somewhere between the 11th and 7th millennium BC.