12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.

Creating Value in Healthcare: The Need for Innovative Solutions.

The combined impact of an aging population's healthcare needs and the growing prevalence of chronic disease has, and will continue to have, a significant impact on healthcare capacity and economics. In the context of resource constraints there is a tendency to focus on doing more with less. However, the real opportunity may lie in building capacity by doing things differently. The authors propose a new paradigm for innovative hospital care and illustrate its potential by examining recent endeavours at a large, full-service hospital in Southern Ontario. Innovation is about finding new ways of doing things that lead to better outcomes. Many healthcare leaders characterize their organizations as innovative, asserting they are committed to identifying and implementing best practices in clinical care. Despite this pledge, the lag time in the clinical implementation of translational research can be up to 17 years (Morris et al. 2011). Clearly, there is an opportunity to achieve better outcomes by developing a more systematic approach to implementing this type of research. Creating a culture of innovation in which ideas thrive and there is a commitment to adopting proven best practices should be part of the solution.

Atomoxetine treatment of attention-deficit/hyperactivity disorder in young adults with assessment of functional outcomes: a randomized, double-blind, placebo-controlled clinical trial.

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is associated with significant impairment in multiple functional domains. This trial evaluated efficacy in ADHD symptoms and functional outcomes in young adults treated with atomoxetine. METHODS: Young adults (18-30 years old) with ADHD were randomized to 12 weeks of double-blind treatment with atomoxetine (n = 220) or placebo (n = 225). The primary efficacy measure of ADHD symptom change was Conners' Adult ADHD Rating Scale (CAARS): Investigator-Rated: Screening Version Total ADHD Symptoms score with adult prompts. Secondary outcomes scales included the Adult ADHD Quality of Life-29, Clinical Global Impression-ADHD-Severity, Patient Global Impression-Improvement, CAARS Self-Report, Behavior Rating Inventory of Executive Function-Adult Version Self-Report, and assessments of depression, anxiety, sleepiness, driving behaviors, social adaptation, and substance use. RESULTS: Atomoxetine was superior to placebo on CAARS: Investigator-Rated: Screening Version (atomoxetine [least-squares mean ± SE, -13.6 ± 0.8] vs placebo [-9.3 ± 0.8], 95% confidence interval [-6.35 to -2.37], P < 0.001), Clinical Global Impression-ADHD-Severity (atomoxetine [-1.1 ± 0.1] vs placebo [-0.7 ± 0.1], 95% confidence interval [-0.63 to -0.24], P < 0.001), and CAARS Self-Report (atomoxetine [-11.9 ± 0.8] vs placebo [-7.8 ± 0.7], 95% confidence interval [-5.94 to -2.15], P < 0.001) but not on Patient Global Impression-Improvement. In addition, atomoxetine was superior to placebo on Adult ADHD Quality of Life-29 and Behavior Rating Inventory of Executive Function-Adult Version Self-Report. Additional assessments failed to detect significant differences (P ≥ 0.05) between atomoxetine and placebo. The adverse event profile was similar to that observed in other atomoxetine studies. Nausea, decreased appetite, insomnia, dry mouth, irritability, dizziness, and dyspepsia were reported significantly more often with atomoxetine than with placebo. CONCLUSIONS: Atomoxetine reduced ADHD symptoms and improved quality of life and executive functioning deficits in young adults compared with placebo. Atomoxetine was also generally well tolerated.

Heavy and light beer: a carbon isotope approach to detect C(4) carbon in beers of different origins, styles, and prices.

The carbon isotope ratios (delta(13)C) of 160 beers from around the world ranged from -27.3 to -14.9 per thousand, primarily due to variation in the percentage of C(3) or C(4) plant carbon in the final product. Thirty-one percent of beers had a carbon signature of C(3) plants (barley, rice, etc.), whereas the remaining 69% contained some C(3)-C(4) mixture (mean of mixtures, 39 +/- 11% C(4) carbon). Use of C(4) carbon (corn, cane sugar, etc.) was not confined to beers from any particular region (Pacific Rim, Mexico, Brazil, Europe, Canada, and the United States). However, the delta(13)C of European beers indicated mostly C(3) plant carbon. In contrast, U.S. and Canadian beers contained either only C(3) or C(3)-C(4) mixtures; Brazilian, Mexican, and Pacific Rim beers were mostly C(3)-C(4) mixtures. Among different lagers, U.S.-style lagers generally contained more C(4) carbon than did imported pilsners. Among different ales, those brewed by large high-production breweries contained significant proportions of C(4) carbon, while C(4) carbon was not detected in microbrewery or home-brew ales. Furthermore, inexpensive beers generally contained more C(4) carbon than expensive beers.