Nothing has come out of the meeting as the FDA is looking for input from the commitee. Here is the Agenda discussed in general in today's Bioequivalence markers for locally acting GI drugs: " DAY 2 (July 23, 2008) DAY 2 (Topic 1) – Bioequivalence Methods for Locally Acting Drugs that Treat Gastrointestinal (GI) Conditions The typical use of in vivo bioequivalence studies that compare pharmacokinetic parameters may not be an appropriate surrogate of pharmacological activity for locally acting drugs that are used to treat GI conditions. Selection of the most appropriate bioequivalence method requires understanding of physicochemical properties of drugs, product design, and drug product safety and efficacy profiles. After framing the topic, we will present an approach and proposal as to current thinking on the bioequivalence issues for these locally acting drugs." From what I can interpret a simple dissolution method simply won't cut it as Michel DeRosen as always claimed it.
" The typical use of in vivo bioequivalence studies that compare pharmacokinetic parameters may not be an appropriate surrogate of pharmacological activity for locally acting drugs that are used to treat GI conditions." Surrogate???. Does the FDA truly means Substitute?. The Street already knows more stringent assays need to be conducted thus reflected on late yesterday and today price action. As far as Art from Akorn, he already knew a simple dissolution method where 'you put an active ingredient in a test tube, shake it and say we have a generic oral Vancocin just won't work' as he bailed on june 25 of 2008 soon after the announcement of today meeting: http://biz.yahoo.com/ap/080625/akorn_insider_transactions.html?.v=1 And yes the little 'Limerick of Amando' still sticks!LOL.