X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 171 / 263

687 views

0 shares

0 downloads

0 comments

171 / 263

1

this initial discussion and information sharing, to the Biopharmaceutic Subcommittee meetings or to perhaps another ACPS meeting where we can talk about and debate in general in a more in-depth fashion.  So at this meeting, we seek your recommendations on how to develop this information needed to enhance the science in this area.

So as you may have figured out already from some of the comments, the bioavailability and bioequivalence of endogenous drug substances needs special considerations.  And I'll go over my infamous diagrammatic explanations in a second.  These considerations were not addressed in our general bioavailability/bioequivalence guidance, and if you're familiar with that document, which I think we're very proud of, it still left out those considerations for those type of products and hence our need to really discuss what we've done so far successfully on several of the products and how that success can be extended to other products where it's not quite as clear-cut.

The specific things that we do have guidances on that relate to this topic are specifically two compounds or two endogenous substances, the first being a

Document info
Document views687
Page views687
Page last viewedFri Dec 09 16:13:55 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments