QbD for Generic Drugs: A Case Study for Immediate-Release Products

  • Type:
    Conference Presentation
  • Conference Type:
    AIChE Annual Meeting
  • Presentation Date:
    November 7, 2010
  • Skill Level:
  • PDHs:

Share This Post:

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.
Quality by design (QbD) is a systematic approach for product and process design and development to ensure predefined product quality. Although the recent ICH guidelines (Q8-Q10) have provided an outline for development of “high quality” pharmaceutical products based on a comprehensive QbD approach, there are very few publications describing how to implement the QbD principles on the development of generic drug products. This presentation will discuss a case study of the pharmaceutical development report for an immediate-release drug product, which was developed by the FDA/Industry Working Group in 2010. This example built on the Conformia ACE case study by treating that product as the reference product for development of a generic product. The purpose of this case study is to illustrate how to implement the principles contained in ICH guidelines (Q8 , Q9, and Q10) during the development of generic drug products.



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