X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 173 / 263

529 views

0 shares

0 downloads

0 comments

173 / 263

1

Again, the next slide or two or three is something that the committee saw yesterday in my other talk.  It's just important to point out that these are pharmaceutical equivalents.  So we're not dealing with therapeutic substitution or any substitution of different types of dosage forms.  When we do these comparisons or bioequivalence comparisons, we're dealing with the pharmaceutical equivalents containing the exact same amount of drug substance in the same type of dosage form.

And I think that I went over this particular slide, that we're really in the long run or at the end, we're interested in assuring therapeutic equivalence, and we, through our very extensive experience in a wide variety of drugs, some endogenous, some others, we've arrived at, through many years of experience in assuring TE, or therapeutic equivalence, the most efficient ways to do proper bioequivalence tests with proper analysis and acceptance criteria.

I said yesterday this is my favorite slide and I can't be restrained from throwing it into every talk.  It actually is relevant, and I have three versions of this.  Here's my general.  I don't want to call it generic

Document info
Document views529
Page views529
Page last viewedSun Dec 04 02:35:12 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments