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Background: For pharmaceutical products, an in-depth understanding of manufacturing processes and quality risks associated with quality by design (QbD) development enables the production of high-quality products. Product recall due to quality issues could be minimized for QbD-developed products. Furthermore, the review period instituted by regulatory authorities could be shortened by allowing reviewers to access technical documents with QbD elements. The aim of this study was to examine the impact of QbD development from the viewpoints of regulatory flexibility, product quality related to recall, and review period in Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Methods: QbD developments for new active ingredients, approved from 2009 to 2018, were surveyed in the PMDA review reports, and review periods were investigated on the PMDA website. Voluntary product recalls and their rationale were investigated using the website of the Japan Ministry of Health, Labour and Welfare. Results: Although the developmental ratio with QbD elements was increased from 9% in 2009 to 71% in 2018, the development of design space for drug substances and products between 2009 and 2018 was only 2%, and real time release testing (RTRT) for drug products was limited to 3%. Voluntary recall and extension of the review period for QbD-developed products were not observed. Conclusion: The advantages of systematic QbD development were suggested for no voluntary recall of QbD-developed products. Conversely, applicants did not actively seek regulatory flexibility with design space or RTRT, and QbD development failed to impact the PMDA review period. [ABSTRACT FROM AUTHOR]

An emotional event can provoke somatic symptoms as a consequence of brain responses accompanying reactions of the autonomic nervous system (ANS). ANS consists of the sympathetic nervous system and the parasympathetic nervous system, and their anatomical and physiological mechanisms are different. The aim of this study was to evaluate the time lag between the responses of electroencephalography (EEG) and the parasympathetic nervous system (from electrocardiography; ECG) during emotional recall. EEG and ECG of healthy young adults were simultaneously recorded during the recall of emotionally pleasant and unpleasant audiovisual stimuli, with three repetitions. A time series (TS) of relative power spectra from EEG and a TS of power spectral values in high frequency (HF) of RR intervals in ECG were obtained using fast Fourier transform. The time lag between the TS of EEG and HF was calculated using wavelet cross‐correlation analysis. The results indicated that the cerebral cortex responded earlier than the parasympathetic nervous system to the pleasant stimuli. In contrast, the parasympathetic nervous system responded earlier than the cerebral cortex to the unpleasant stimuli. These events constantly appeared in both unfamiliar and familiar situations. This study quantitatively shows that the parasympathetic nervous system quickly and constantly reacts to emotionally unpleasant stimuli. © 2019 Institute of Electrical Engineers of Japan. Published by John Wiley & Sons, Inc. [ABSTRACT FROM AUTHOR]

The current paper presents two experiments investigating the effect of presence versus absence of compulsory number marking in a native language on a speaker's ability to recall number information from photos. In Experiment 1, monolingual English and Japanese adults were shown a sequence of 110 photos after which they were asked questions about the photos. We found that the English participants showed a significantly higher accuracy rate for questions testing recall for number information when the correct answer was "2" (instead of "1") than Japanese participants. In Experiment 2, English and Japanese adults engaged in the same task as in Experiment 1 with an addition that explored reasons for the results found in Experiment 1. The results of Experiment 2 were in line with the results of Experiment 1, but also suggested that the results could not be attributed to differences in guessing patterns between the two groups or the type of linguistic constructions used in the test situations. The current study suggests that native language affects speakers' ability to recall number information from scenes and thus provides evidence for the Whorfian hypothesis., (© 2020 Cognitive Science Society, Inc.)