X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 37 / 263

939 views

0 shares

0 downloads

0 comments

37 / 263

1

assessment of pharmaceutical equivalence, manufacturing process, labeling.  These are all components to that that makes a decision whether a product is therapeutically equivalent or not.

We also discussed yesterday the concept of the comparability protocol which is directly linked to this, but at the same time, I think when you look at the information base that we use to set specifications and identify critical formulation variables and so forth, there's a lot of information that exists today that is not effectively used.

One of the concepts that was discussed yesterday was design your own SUPAC or make your own SUPAC or customized SUPAC, whatever you would like to call that.

I think we need to find effective and efficient methods for ensuring that product performance is unchanged and the manufacturing process changes that occur keep improving the efficiency, and that's sort of a continuous improvement model that comes about.  So that's a challenge and that's what we discussed yesterday.

Today, we'll discuss a proposal on a parametric tolerance interval approach to dose content

Document info
Document views939
Page views939
Page last viewedSun Jan 22 22:47:30 UTC 2017
Pages263
Paragraphs1551
Words48110

Comments