X hits on this document

Powerpoint document

Quality by Design: Next Steps to Realize Opportunities? - page 8 / 37

114 views

0 shares

0 downloads

0 comments

8 / 37

Example Attribute: Bioavailability

Objective: Maximize & reproducible

Absorption mechanism (passive, active, site specific)

Physico-chemical attributes (solubility, dissolution rate, salt selection, particle size, morphic form, stability of drug substance ….)

Formulation design (disintegrating agent, wetting agent, solubilizer, pH modifiers, absorption enhancers,..)

Process design (wet/dry granulation, lubrication, compaction,….)

Specifications and controls on all critical variables

Document info
Document views114
Page views114
Page last viewedThu Jan 19 13:28:40 UTC 2017
Pages37
Paragraphs609
Words2099

Comments