Dissolution testing plays many important roles throughout the pharmaceutical industry, from the research and development of drug products to the control and evaluation of drug quality. However, it is ...
The US Food and Drug Administration (FDA) on Wednesday released final guidance for sponsors on when a standard release test and criteria may be used in lieu of extensive method development and ...
The British Pharmacopoeia on Monday released its response to its consultation on dissolution testing and announced its plans to update its approach within its product monographs. The British ...
Dissolution testing plays an important role throughout the life cycle of a pharmaceutical product, i.e., from evaluating how quickly a compound dissolves into solution in controlled conditions to ...
Many solid-dose oral drug products are engineered to release their active ingredients into the body at a certain rate. Techniques for measuring the dissolution or degradation of a drug product in ...
The dissolution profile of inhaled drugs underpins therapeutic efficacy and is an area of increasing regulatory scrutiny, particularly for the demonstration of bioequivalence in a generic. The new ...
FDA agents recall 100 out of 1,000 bottles of Chlorthalidone sold nationwide because they “failed dissolution specifications.” ...