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Quality by Design Approaches for Orally Inhaled and Nasal Drug Products in the USA

Peri P.

RDD Europe 2007. Volume , 2007: 59-60.

Abstract:

An article with this title was submitted, reviewed and accepted for publication in the Proceedings of RDD Europe, 2007, but withdrawn by the authors as we went to press. The article was authored by the presenter, S. Prasad Peri and his colleague Richard T. Lostritto (Pharmaceutical Assessment Lead and Director of Division III, respectively) from FDA’s Office of New Drug Quality Assessment (ONDQA), Pulmonary and Allergy Drug Products, Silver Spring, Maryland. We apologize for any inconvenience this withdrawal may have caused. The article was withdrawn following an ONDQA senior management decision to withhold all future FDA articles on the topic of Quality by Design (QbD) until after the publication of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Expert Working Groups’ discussions on this subject. Progress in this area can be sought at the ICH website (www.ich.org). We are pleased to announce that Dr. Peri was allowed to present his work in a podium presentation at RDD Europe 2007, and engage in discussion with meeting registrants. We are also pleased that FDA have agreed that we may post Dr. Peri’s slides on our website (www.rddonline.com) as a substitute for the presentation of their article. These slides will be posted to coincide with the electronic publication of the proceedings on June 1, 2007.