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Upon completion of this lecture of the eCourse, the participant should be able to:

• Review scale up & QbD aspects in manufacturing of amorphous solid dispersions. Describe how the QbD principles may be applied to the development of enabled formulations of poorly soluble drugs.
• Discuss scale up of HME and/or spray drying in brief. Discuss various CPPs, CQAs, and risk assessment in the manufacture of amorphous solid dispersions. 
• Discuss identification of CQAs of enabled formulations of poorly soluble drugs and key aspects of control during scale-up of these products.
• Discuss a systematic approach with the help of QbD principles to melt extrusion based on an understanding of the interplay between process and product enabling a rapid scale up.