The conference demonstrated that consensus is difficult to achieve and only small steps are possible wherever diverging standards have been defined long ago. Yet, when authorities are still struggling for the best solution, early contribution of experts from industry, CROs and academia is extremely fruitful. This became evident for irritation and sensitisation studies with patches as well as for studies with liposomal formulations.
As new and innovative feature, a monkey survey was introduced allowing the participants to vote for solutions.
The GBHI conference starts with a summary of the preceding conference in 2016 in Washington, followed by the topics “Necessity of multiple dose studies”, “Transdermal Therapeutic Systems” and “Liposomal parenteral formulations”. Vivid discussions between authorities, industry and university are expected.
This meeting is a must-attend for everyone involved in planning and realisation of bioequivalence trials. For more information, please visit the official website.