X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 170 / 263

570 views

0 shares

0 downloads

0 comments

170 / 263

1

are still here, that you actually came and gave us your input on that.

The topic today that I'm starting off with is a much more general topic than was discussed during the comment period in that it's the bioavailability and bioequivalence of endogenous substance drug products in general and what are the concepts behind generally looking at those things in endogenous drug substances.

So I'm again the lead-off person for this topic.  You'll be seeing later on a couple of very nice examples of this that we've had some experience with, and we're going to try and work this into a discussion of what are the general principles of dealing with these type of products and what are the variables and things you have to look at in deciding how to determine bioavailability and bioequivalence.  So this is again, to use Ajaz's previous term, an awareness topic discussion or it's the first step in the discussion that may follow on this general topic, and the purpose of this whole discussion is to provide information to the committee on the challenges for BA and BE assessment of endogenous drugs in general.

Perhaps at later times, we'll take this, after

Document info
Document views570
Page views570
Page last viewedMon Dec 05 09:17:16 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments