27. April 2018
This article reviews regulatory considerations for companies wishing to develop drugs for delivery via the respiratory tract (e.g., by oral inhalation or intranasally) using molecules previously approved for a different therapeutic indication and/or a different delivery route. Conceptually, such repurposing has many medical and business advantages, but turning promising ideas into real products requires overcoming a number of practical challenges. Obtaining regulatory approval to market a...
29. March 2017
ABSTRACT: Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products.Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by a lack of publically available information on elemental impurity levels in common...
14. February 2017
Abstract 5w?>The morbidity and mortality toll of pediatric cancer affects the public health of children worldwide, but despite the gains in the fight against cancer, more progress needs to take place against this disease, which is a leading cause of death and chronic disability in children. In response, leading regulatory authorities in the developed world have been ratcheting up their efforts to induce the private sector to expand their research and development focus during drug development...
22. September 2016
Abstract: Background: In this era of evolution, quality and safety of pharmaceutical dosage forms have been given a prime importance. In this context, a detailed knowledge about physical and chemical properties of excipients is not sufficient, but information about safety and regulatory status of these materials is now essential to know. The present work will be beneficial to focus more on the safety, quality and stability of pharmaceutical product. Objective: Study of regulatory mechanism for...