A strategic approach towards mass balance investigations in pharmaceutical drug substance release testing: A peculiar out of specification case study encountered during API manufacture.

Mass balance in drug substances release testing is a critical quality attribute in pharmaceutical manufacturing that continues to challenge modern analytical characterization. This specific perspective of mass balance is lacking in literature, and the following work addresses the knowledge gap related to this topic by examining an in-depth case study and detailing the systematic investigation into mass imbalance observed during release testing of a small molecule API. The process followed a logical stepwise progression beginning with most probable causes and expanded to more obscure causes that require a deeper examination of the API in question until the undetected impurity in question was finally identified.

Capturing what matters: A retrospective observational study of advance care planning documentation at an academic medical center during the COVID-19 pandemic.

Background: Advance care planning allows patients to share their preferences for medical care with the aim of ensuring goal-concordant care in times of serious illness. The morbidity and mortality of the COVID-19 pandemic has increased the importance and public visibility of advance care planning. However, little is known about the frequency and quality of advance care planning documentation during the pandemic.

Ask About What Matters: An Intervention to Improve Accessible Advance Care Planning Documentation.

Context: Advance care planning (ACP) informs future medical decision-making, especially for patients with advanced age or serious illness. For clinicians to act on these preferences, or continue the ACP conversation as illness progresses, documentation of ACP discussions must be readily accessible within the electronic health record (EHR).

Objectives: Develop an intervention to improve accessible ACP documentation for hospitalized patients and assess its impact on viewing and documentation of ACP conversations within a specific EHR location.