Ramon Verduzco

2 Questions 2 Answers 0 Followers

Questions related from Ramon Verduzco

Re: In vitro release testing; How to reject outlier data?

I developed an IVRT test for a cream using 200 mL mini-paddle type 2 with immersion cell. Sometimes I observe one or two abnormally fast release rates, where most of the results are of a certain...

09 May 2018 5,367 0 View

Question regarding an FDA guidance on topical dermatological Drug Product NDAs and ANDAs. ?

"For a topical solution drug product, in vivo bioequivalence may be waived if the inactive ingredients in the product are qualitatively (Q1 ) identical and quantitatively (Q2 ) essentially the...

24 April 2017 4,485 1 View