Can A Design Space Be Built On Material Attributes Alone?

  • Type:
    Conference Presentation
  • Conference Type:
    AIChE Annual Meeting
  • Presentation Date:
    November 10, 2010
  • PDHs:

Share This Post:

In April, 2009, the PhRMA Drug Product Technical Group sponsored an industry workshop to explore the practicality and limitations of defining a design space in terms of material attributes rather than process variables. This presentation summarizes and expands on the output of this workshop. A material-attribute design space would be independent of scale and configuration of process equipment and the associated process variables. For this reason, it would be portable in the sense that post-approval changes of equipment scale, nameplate, or location would not require regulatory approval. A hypothetical case study of an immediate release oral tablet is presented to illustrate how such a design space could be constructed and implemented.
Once the content has been viewed and you have attested to it, you will be able to download and print a certificate for PDH credits. If you have already viewed this content, please click here to login.



Do you already own this?

Log In for instructions on accessing this content.


AIChE Member Credits 0.5
AIChE Members $15.00
AIChE Undergraduate Student Members Free
AIChE Graduate Student Members Free
Non-Members $25.00