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November 28, 2017

Drug Delivery Systems for Peptides and Proteins

A summary presentation of drug delivery systems with a view to understanding  the specific challenges posed by administration  of peptides and proteins. All routes of administration are considered

November 28, 2017

Lyophilization: Development through Technology Transfer - a QBD Perspective

A presentation examining  Quality by Design challenges for the development of lyophilized products. The complexity of the process plus recent advances in technology make lyophilization quality by design a still much discussed  topic.

November 28, 2017

Sterile Drug Production Practices: USP <797> vs. CGMPs

An informative presentation by Ian Devau, (FDA Bureau Chief ) regarding the differences between the cGMPs and USP<797> with respect to the manufacture of sterile drug products in compounding pharmacies and drug product manufacturing sites. The presentation raises some interesting issues for this complicated topic. 

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