Current Edition

Quality by Design in the Development: Benefit or Bureaucratic Burden?

Petra Botzem and Dr Thomas Hille of LTS Lohmann
answer this provoking question in their paper on the
ICH guideline Q8, with focus on Transdermal Delivery
Systems (TDS) development, providing insight on why
it is beneficial. Due to its well-structured content, the
referenced guideline ICH Q8 describes well-established
development strategies, supplying a platform for
controlled and organised development, not only for