Application of model-informed drug development (MIDD) for dose selection in regulatory submissions for drug approval in Japan.

Model-informed drug development (MIDD) is an approach to improve the efficiency of drug development. To promote awareness and application of MIDD in Japan, the Data Science Expert Committee of the Drug Evaluation Committee in the Japan Pharmaceutical Manufacturers Association established a task force, which surveyed MIDD applications for approved products in Japan. This study aimed to reveal the trends and challenges in the use of MIDD by analyzing the survey results.

Diffusion of White-Hat Botnet Using Lifespan with Controllable Ripple Effect for Malware Removal in IoT Networks.

Self-propagating malware has been infecting thousands of IoT devices and causing security breaches worldwide. Mitigating and cleaning self-propagating malware is important but challenging because they propagate unpredictably. White-hat botnets have been used to combat self-propagating malware with the concept of fight fire-with-fire.

Botnet Defense System: Observability, Controllability, and Basic Command and Control Strategy.

This paper deals with the observability, controllability, and command and control strategy in the Botnet Defense System (BDS) that disinfects malicious botnets with white-hat botnets. The BDS defends an IoT system built over the Internet. The Internet is characterized by openness, but not all nodes are observable and controllable.

Preparation of a Bioadhesive Poly(Acrylic Acid)/Polyvinylpyrrolidone Complex Gel and Its Clinical Effect on Dental Hemostasis.

Poly(acrylic acid) (PAA) is a water-soluble synthetic polymer that exhibits bioadhesive properties and has been applied in various novel medical devices, such as drug-delivery carriers and hemostatic agents. PAA forms a water-insoluble complex when mixed with polyvinylpyrrolidone (PVP). If PAA and PVP are mixed in water, they form an aggregated precipitate, which neither swells nor adheres to tissues.

Machine Learning White-Hat Worm Launcher for Tactical Response by Zoning in Botnet Defense System.

Malicious botnets such as Mirai are a major threat to IoT networks regarding cyber security. The Botnet Defense System (BDS) is a network security system based on the concept of "fight fire with fire", and it uses white-hat botnets to fight against malicious botnets. However, the existing white-hat Worm Launcher of the BDS decides the number of white-hat worms, but it does not consider the white-hat worms' placement.

Monitoring and Predicting the Size of Fine Particles Prepared in a Fluidized-Bed Granulator Using a Handheld-Type Raman Spectrometer.

We prepared two kinds of fine particles by treating lactose monohydrate (Lac) with the same formulation in a fluidized-bed granulator, which differed in the spraying air pressure. Raman intensities of treated Lac during processing were measured using a handheld-type Raman spectrometer and plotted against particle size. As particle size increased, Raman intensity decreased in both operating conditions.

Combinations of Drug Candidate Properties Affecting Development Success and Discontinuation for 5 Diseases: Lymphoma, Non-Small Cell Lung Cancer, Arthritis, Depression, and Alzheimer Disease.

The effects of the properties of drug candidates on their successful approval for the treatment of diseases are substantial. However, the success rate of candidates when their properties are combined has not been sufficiently evaluated. We aimed to identify combinations of properties (target, action, and modality) that increased the approval success rate of drug candidates for 5 diseases as well as to understand the characteristics of discontinued candidates.

Approval success rates of drug candidates based on target, action, modality, application, and their combinations.

The current success rate of a drug candidate, from the beginning of the clinical trial to receiving marketing approval, is about 10%-20%, and it has not changed during the past few decades. Therefore, pharmaceutical companies are under pressure to select one compound, among many others, with a high probability of success. The differences in drug features affect their probabilities of approval success.

White-Hat Worm to Fight Malware and Its Evaluation by Agent-Oriented Petri Nets .

A new kind of malware called is spreading like wildfire. Mirai is characterized by targeting Internet of Things (IoT) devices. Since IoT devices are increasing explosively, it is not realistic to manage their vulnerability by human-wave tactics.

Gene expression profiling of granule cells and Purkinje cells in the zebrafish cerebellum.

The structure of the neural circuitry of the cerebellum, which functions in some types of motor learning and coordination, is generally conserved among vertebrates. However, some cerebellar features are species specific. It is not clear which genes are involved in forming these conserved and species-specific structures and functions.

Type IV Collagen Controls the Axogenesis of Cerebellar Granule Cells by Regulating Basement Membrane Integrity in Zebrafish.

Granule cells (GCs) are the major glutamatergic neurons in the cerebellum, and GC axon formation is an initial step in establishing functional cerebellar circuits. In the zebrafish cerebellum, GCs can be classified into rostromedial and caudolateral groups, according to the locations of their somata in the corresponding cerebellar lobes. The axons of the GCs in the caudolateral lobes terminate on crest cells in the dorsal hindbrain, as well as forming en passant synapses with Purkinje cells in the cerebellum.

Establishment of Gal4 transgenic zebrafish lines for analysis of development of cerebellar neural circuitry.

The cerebellum is involved in some forms of motor coordination and motor learning. Here we isolated transgenic (Tg) zebrafish lines that express a modified version of Gal4-VP16 (GFF) in the cerebellar neural circuits: granule, Purkinje, or eurydendroid cells, Bergmann glia, or the neurons in the inferior olive nuclei (IO) which send climbing fibers to Purkinje cells, with the transposon Tol2 system. By combining GFF lines with Tg lines carrying a reporter gene located downstream of Gal4 binding sequences (upstream activating sequence: UAS), we investigated the anatomy and developmental processes of the cerebellar neural circuitry.