Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies.

In consideration of the recent ICH Quality Discussion Group (QDG) recommended revision to the ICH series of stability guidelines, the IQ Consortium (International Consortium for Innovation and Quality in Pharmaceutical Development) Science- and Risk-based Stability Working Group conducted a comprehensive review of ICH Q1A, Q1B, Q1C, Q1D, Q1E, and Q5C to identify areas where the guidelines could be clarified, updated, and amended to reflect the potential knowledge gained from current risk-based predictive stability tools and to consider other science- and risk-based stability strategies in accordance with ICH Q8-12. The recommendations propose a holistic approach to stability understanding, utilizing historical data, prior knowledge, modeling, and a risk assessment process to expand the concept of what could be included (or would be acceptable) in the core stability data package, including type and amount of stability evidence, assignment of retest period and shelf-life for a new product, and assessment of the impact of post-approval changes.

Exploring cancer survivors' attitudes, perceptions, and concerns about using medical cannabis for symptom and side effect management: A qualitative focus group study.

The purpose of this study is to gain a greater understanding of cancer survivors' attitudes, perspectives, and concerns about medical cannabinoids (MCs) for cancer symptom and side effect management. Using qualitative methods, we conducted four focus groups (n = 19) with cancer survivors recruited from a community-based cancer wellness center. Groups were audio-recorded and facilitated by experienced co-moderators who directed discussion using a semi-structured interview guide. Transcripts were coded using principles from Grounded Theory. Analyses revealed the following ten themes and percentages of codes applied: 1) Attitudes & Beliefs (25.3%), 2) Access (17.1%), 3) Information (15.5%), 4) Concern (14%), 5) How MCs Helped (12.6%), 6) Comfort (4.3%), 7) Confusion (3.6%), 8) Trust/Distrust (3.1%), 9) Behaviors (2.3%), and 10) Support (2.2%). Participants reported that MCs offer potential benefits for symptom management and side effect relief, especially in reducing and managing pain. Despite the growing number of states that are legalizing MCs, significant barriers exist that make knowledge and adequate access a challenge for many.

Long-Term Use of Mixed-Oil Lipid Emulsion in Adult Home Parenteral Nutrition Patients: A Case Series.

BACKGROUND: Despite providing significant benefits, home parenteral nutrition (HPN) can be associated with complications such as infections, intestinal failure-associated liver disease, and metabolic abnormalities. Soybean oil (SO)-based intravenous lipid emulsion (ILE) has been noted to contribute to some of these complications, leading to the development of alternative sources of ILE. Mixed-oil (MO) ILE has recently been approved for use in adults with short-term studies revealing a benefit over SO ILE. Currently there is a paucity of data regarding long-term use in the HPN population. METHODS: The current study reports our experience with MO ILE in 9 HPN patients. RESULTS: A total of 9 patients (3 women and 6 men) with average age of 48.1 ± 15.1 years and a median HPN use of 9.9 years (9.0 months-30.7 years) were transitioned from SO ILE to MO ILE as a result of intolerance. The 9 patients tolerated MO ILE well for 140.7 ± 29.7 days. The percentage of calories provided through ILE increased from 7.6 ± 6.5% to 18.4 ± 8.2% (P = .003), whereas the dextrose decreased from 66.9 ± 8.4% to 56.9 ± 5.5% (P = .0007). Although statistical significance was not reached, there was a trend toward improvement in alkaline phosphatase from 138.0 (52-884) to 106 (47-512; P = .09). CONCLUSION: MO ILE was well tolerated in this small cohort and led to improvement in the macronutrient composition of HPN while providing a trend toward improvement in liver studies. These results are promising; however, additional randomized control trials are needed to delineate the true benefit.