10. September 2018

Disintegration is a physical process related to the mechanical breakdown of a tablet or granulate particle into smaller particles. This review investigates disintegration mechanisms, pharmacopeial use of the disintegration test and scientific studies showing its utility and potential as a pharmaceutical performance test. With a proper dosage form understanding and demonstration/justification of the mechanistic details of drug dissolution from a dosage form, dissolution testing might be replaced...

01. November 2017

The FDA guidance on application of the Biopharmaceutics Classification System (BCS) for waiver of in-vivo bioequivalence (BE) studies was issued in August 2000. Since then, this guidance has created world-wide interest among biopharmaceutical scientists in regulatory agencies, academia, and industry towards its implementation and further expansion.