Provided below are:
● the table of contents (p.1) ● information about IPQ (p.2), and ● the editor’s note on the issue (p.3).
In this issue, IPQ explores the need for excipients that are fit-for-purpose in meeting the complex challenges of formulating, manufacturing, and delivering the new generation of medicines and making them as safe, efficacious, and patient- and distribution-friendly as possible. The five parts of the story focus on: ● a novel excipient review proposal from FDA and stakeholder comments ● industry thought leaders on the novel excipient drivers ● the issues involving subcutaneous biotherapeutics, pediatrics, and delayed release ● USP initiatives supporting novel excipient development, and ● assessing and managing excipient risks.