Drug Delivery Leader

Oct 1, 2024 | drugdeliveryleader.com | Will Parker

By Will Parker, Manager, Extractables & Leachables The scrutiny of extractables and leachables (E&L) from pharmaceutical packaging and delivery systems has intensified significantly since its inception in the mid-1990s. Regulatory agencies have become more knowledgeable, leading to heightened expectations for the industry. Guidelines such as USP and, along with injectable drug recommendations from the Product Quality Research Institute (PQRI), exemplify this evolving landscape.

Jun 28, 2024 | drugdeliveryleader.com | Jason Brown

By Jason Brown, Senior Manager, Analytical Sciences, R&D, Adare Pharma Solutions Following the release of the FDA’s guidance on Nitrosamine Drug Substance-Related Impurities (NDSRIs), pharmaceutical companies need to adopt a systematic approach for identifying susceptible Active Pharmaceutical Ingredients (APIs). Despite extensive research and industry efforts, a clear definition of APIs at risk for NDSRI formation remains elusive.

Jun 6, 2024 | drugdeliveryleader.com | Fran DeGrazio

Source: Kymanox Corporation By Fran DeGrazio, Executive Advisor, Kymanox Corporation Materials used in a drug package or device design are fundamental to ensuring a safe and effective drug development program. The recent growth in complex therapeutics has increased demand for sophisticated packaging and device designs as these products are extremely sensitive to their environmental and storage conditions.

Jun 4, 2024 | drugdeliveryleader.com | Jessica Sanford

By Jessica Sanford, Ph.D., Senior Human Factors Engineer The COVID-19 pandemic has significantly impacted education, resulting in a notable decline in literacy rates among children and adolescents. This decline is reflected in reading test scores and national assessments, raising concerns about long-term effects and disproportionate impacts on vulnerable groups.

Jun 4, 2024 | drugdeliveryleader.com | Jessica Sanford

By Jessica Sanford, Ph.D. Senior Human Factors Engineer, Battelle As the US population ages and the prevalence of cognitive decline increases, new research into cognitive and memory-related drug and combination device development is on the rise. This surge brings a heightened need for human factors testing that includes target users, potentially requiring study participants with cognitive impairments to determine if they can self-administer treatments.