Quality by Design for Generic Drugs

  • Type:
    Conference Presentation
  • Conference Type:
    AIChE Annual Meeting
  • Presentation Date:
    October 17, 2011
  • Duration:
    30 minutes
  • Skill Level:
  • PDHs:

Share This Post:

To facilitate the implementation of Quality by Design (QbD) for abbreviated new drug application (ANDA), Office of Generic Drugs (OGD) has developed mock QbD examples for immediate release (IR) and modified release (MR) dosage forms. This presentation will provide insight into OGD’s current thinking on QbD filing requirement and definition of some QbD nomenclatures. The Question-based Review (QbR) system is to be revised in 2011 and 2012 and is expected to be fully implemented by January 2013. This presentation will also discuss some practical tools and types of pharmaceutical development studies ANDA applicants may use as they implement QbD in their pharmaceutical development process.
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?



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