Can I read Biowaiver Monograph for Diclofenac on EtoBox?

Biowaiver Monograph for Diclofenac by serdaralpan is a document available to read on EtoBox.

What is Biowaiver Monograph for Diclofenac about?

This document reviews literature data to determine if a biowaiver of in vivo bioequivalence testing is advisable for immediate release solid oral dosage forms containing diclofenac potassium or diclofenac sodium. Both salts are classified as BCS Class II drugs due to their high permeability and variable solubility. A biowaiver can be recommended if the test and comparator products use the same salt, have identical dosage forms, contain only excipients approved for diclofenac products, and demonstrate simila

Author

serdaralpan

Language

EN