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Quality by Design: Next Steps to Realize Opportunities? - page 9 / 37

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BA Data from pre-CAN and

Exp Toxicology Studies

Simulations Using Dissolution

Absorption Model**

BA is expected to

be significantly

PS Dependent**

Tablet Content Uniformity Model

BA is expected to be PS Independent**

In vivo studies in animals

PS Analysis

Drug

Substance

Delump

(e.g. pass

through

20 mesh)

Is desired PS readily achievable?

Consistent with Model ?

No

Yes

Improve

Model

No

Yes

Recommend Appropriate PS

In-process

Sample

Done

PS Reduction

** At expected dosing range in humans

integrating data from pre-clinical studies.

Christopher Sinko, Ph.D.

Pfizer Global Research & Development

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