Quality by Design in Pharmaceutical Development

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
2010 AIChE Annual Meeting
AIChE Annual Meeting
November 7, 2010 - 7:00pm
More than 70% of the prescriptions in the US are now filled with generic products, and therefore, the industry has the responsibility to continue to provide safe, effective, and affordable medications. In 2009 GPhA initiated a dialogue between the Industry and the US FDA Office of Generics on Quality by Design (QbD) - a systematic approach for designing quality in our products. To facilitate the discussion between the two, FDA provided hypothetical cases on quality target product profile, compatibility between drug and excipients, formulation and process development, and scale-up and control strategies. While many questions still remain to be addressed, there is general agreement between the industry and the FDA on the benefit of quality by design. The purpose of this presentation is to provide the generic industry perspective on QbD.
Professional Development Hours
0.5 PDHs
You will be able to download and print a certificate for these PDH credits once the content has been viewed. If you have already viewed this content, please click here to login.
Presenter(s): 

Would you like to access this content?

No problem. You just have to complete the following steps.

You have completed 0 of 2 steps.

  1. Log in

    You must be logged in to view this content. Log in now.

  2. Purchase Technical Presentation

    You must purchase this technical presentation using one of the options below.
    If you already purchased this content recently, please click here to refresh the system's record of ownerships.

Pricing

Credits 0.5 Use credits
List Price $25.00 Buy now
AIChE Members $15.00 Buy now
AIChE Undergraduate Student Members Free Free access
AIChE Graduate Student Members $15.00 Buy now