Elemental Impurity Analysis in Pharmaceuticals and Implementation of ICH Q3D

whitePaper | July 1, 2023

As its title implies, Annex 1 is the European guidance document for good manufacturing practices of medicinal products. As such, it serves as the road map for sterile drug manufacturers to follow in order to arrive at the pathway to the highest level of sterility, assuring that their medicinal drug products deploy operational best practices, are certifiable, and regulatorily safe.

whitePaper | March 28, 2023

About 70% of new chemical entities (NCEs) are highly insoluble.1 It’s a fact that troubles small biotechnology companies and other drug manufacturers. Indeed, insoluble drugs present a wide range of challenges during development and, if not addressed, can ultimately render drugs ineffective in patients.

whitePaper | December 19, 2019

Welcome to European Pharmaceutical Review’s Application Notes & Whitepapers Supplement 2019. This year’s topics range from analytical techniques for bioprocess investigation, host cell protein analysis and Raman imaging to advice on outsourcing services for product characterisation.

whitePaper | March 27, 2023

European countries have been experiencing medicine shortages due to disruptions in the supply chain. Reshoring the productions of active pharmaceutical ingredients (APIs) is considered as an approach to secure the supply.

whitePaper | November 18, 2022

Small molecule drug development has changed substantially in recent years. With the heightened focus on molecularly targeted therapies, small molecule active pharmaceutical ingredients (APIs).

whitePaper | November 8, 2022

The Asia-Pacific region has emerged as a clinical trial hub due to the ease of regulatory compliance, low trial costs, rising patient population, and the availability of top clinical institutions.