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

Jan 4, 2018

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 TDS. ...

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