Posting: # 20440
when Drugs@FDAdoes not have Rld label guidelines for a drug, which one should be referred? Its USFDA submission
Edit: See this post #3 and follow the Forum’s Policy. [Helmut]
Posting: # 20443
do you see Guidelines on top of the page?
What about the overarching “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA”? If in doubt, initiate a Controlled Correspondence. Otherwise, you risk an R-t-R.
The quality of responses received is directly proportional to the quality of the question asked. ☼