X hits on this document

Word document

FOOD AND DRUG ADMINISTRATION - page 174 / 263

644 views

0 shares

0 downloads

0 comments

174 / 263

1

version because I work for generic drugs, but this is the simple version for the usual non-endogenous oral drug product.  It simply flows again from this first step where we have a solid oral dosage form and that dosage form, I think we can all agree, needs to release the drug and make it available to the body, and so it seems like a simple concept but the drug has to leave the formulation and get into the body to eventually create a therapeutic effect.  And sometimes by therapeutic effects, I mean any effects that a drug caused, both desirable and undesirable.

So the first step usually for an oral product is that product has to disintegrate and then go into solution and once in solution pass across the gut wall.

So when you look at bioequivalence specifically, what you're really looking at ‑‑ and it's an important concept that people get confused about ‑‑ is you're looking at formulation performance and some way to adequately assess how these comparator formulations behave when taken by patients, or if you're doing a study by normal subjects, how they behave, and can a formulator make another product that behaves in exactly the same way.

Document info
Document views644
Page views644
Page last viewedThu Dec 08 05:04:53 UTC 2016
Pages263
Paragraphs1551
Words48110

Comments