EMA and EFPIA workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products

By William Chin, PhD, Scientific Coordinator, EUCRAF

Dose-finding study is an essential phase of drug development where studies need to be conducted to determine the drug dose to be administered to patients with the best expected balance of safety and efficacy. The drug dose will then be used in confirmatory phase-III trials and for marketing authorisation of the drug in the market. However these studies are often insufficiently documented in marketing-authorisation applications received by the EMA. Therefore a joint workhop was organised by the European Medicines Agency (EMA) and the European Federation of Pharmaceutical Industries and Associations on the 4-5 December 2014 at London to address the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicines. 

The aims of the workshop were:

  • To find consensus on methods that medicine developers can use for the estimation of the dose-exposure-response relationship and dose finding
  • To reach agreement on a decision tree to guide the practical implementation of these methods in medicine development
  • To raise awareness of the importance of investigating and understanding the dose-exposure-response relationship as part of medicine development in a systematic way
  • To improve dose recommendations for patients included in the medicines’ summary of product characteristics and for the lifecycle management of the medicine

This 2-day workshop consisted of 6 sessions:

  • Session 1: Setting the scene
  • Session 2: Designs and Methods
  • Session 3: Gap analysis by different therapeutic area
  • Session 4: The importance of D-E-R characterisation in dose selection, labelling and B/R assessment
  • Session 5: Impact on licensing decisions, post-authorisation commitments and lifecycle management of medicinal products 
  • Session 6: Conclusions and Directions for the future

All the presentations are now available at the EMA website.

Source

1.European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products, European Medicines Agency, London, UK, From: 04-05-Dec-2014 (updated), 7 January 2015