X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 206 / 263

728 views

0 shares

0 downloads

0 comments

206 / 263

1

attenuation of differences between non-equivalent formulations.

There are two other characteristics that we really need to think about with this correction procedure.

To summarize our study, all the correction methods are good for 25 percent differences.  They're not good for 12.5.  The horizontal correction method does have some biologic inconsistency.  We know the intrasubject variability in T4 is low.  We know it's a narrow therapeutic margin drug.  If we are to be serious about detecting 12.5 percent differences, then the standard 80 to 125 criteria are probably too broad for T4.  In using TSH, you get more discrimination.

Now, there are many physicians who don't understand or don't trust bioequivalence.  What they really want to know is if you can switch two products and pose no risk to the patient.

Another option to think about in biostudies is if we have a problem with correcting for baseline, why not get rid of the baseline?  Why not study the drug?  Why not study bioequivalence in subjects that don't have any thyroid function?  There's precedence for this for

Document info
Document views728
Page views728
Page last viewedSun Dec 11 06:35:23 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments