22. March 2016
The International Conference on Harmonization Q8 (R2) includes a requirement that “Critical formulation attributes and process parameters are generally identified through an assessment of the extent to which their variation can impact the quality of the drug product,” that is, the need to assess the robustness of a formulation. In this article, a quality-by-design–based definition of a “robust formulation” for a biopharmaceutical product is proposed and illustrated with a case study....
03. February 2016
The chairs of each of the 8 Special Interest Groups of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation have compiled opinions with regard to major challenges for the pharmaceutical sciences over the next 5-10 years. Areas covered are drug design and discovery, natural products, formulation design and pharmaceutical technology, pharmacokinetics /pharmacodynamics and systems pharmacology, translational and personalized medicine, biotechnology, analytical...
21. April 2015
Nicole Buist, Ph.D. is a principal scientist in the Discovery Pharmaceutical Sciences department at Merck & Co., Inc. She is also the 2015 chair of the Excipients Focus Group and a Merck Fellow for Global Health. Coauthors: Ken Liljegren and Thiago Carvalho I often find myself reflecting on how it’s a wonderful time to be alive. New technologies give us new degrees of freedom... http://aapsblog.aaps.org/2015/04/16/no-room-for-boredom-whats-new-in-pharmaceutical-excipients/