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Future Vision of Regulatory Science in the Global Development of Pharmaceuticals and Medical Devices.
PMID: 27040332 [PubMed - in process] (Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan)
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Nakamura M, Ikeda K Tags: Yakugaku Zasshi Source Type: research

New Medical Device Evaluation.
Abstract In this presentation, as a member of the Harmonization by Doing (HBD) project, I discuss the significance of regulatory science in global medical device development and our experience in the international collaboration process for medical devices. In Japan, most innovative medical therapeutic devices were previously developed and exported by foreign-based companies. Due to this device lag, Japanese had minimal opportunities for receiving treatment with innovative medical devices. To address this issue, the Japanese government has actively accepted foreign clinical trial results and promoted global clinical...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Ikeda K Tags: Yakugaku Zasshi Source Type: research

Future Regulatory Science through a Global Product Development Strategy to Overcome the Device Lag.
Abstract Environment that created "medical device lag (MDL)" has changed dramatically, and currently that term is not heard often. This was mainly achieved through the leadership of three groups: government, which determined to overcome MDL and took steps to do so; medical societies, which exhibited accountability in trial participation; and MD companies, which underwent a change in mindset that allowed comprehensive tripartite cooperation to reach the current stage. In particular, the global product development strategy (GPDS) of companies in a changing social environment has taken a new-turn with international ha...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Tsuchii I Tags: Yakugaku Zasshi Source Type: research

Quantitative Decision Making in Drug Development: Pharmacometrics.
Abstract According to the US Food and Drug Administration, pharmacometrics is an emerging science that quantifies drugs, diseases, and trial information to aid efficient drug development and/or regulatory decisions. Quantitative decision making occurs at all stages of drug development. In general, patient-level data are not made available to competitors. However, summary-level data are available. Model-based meta-analysis (MBMA) is a powerful tool for decision making which identifies the candidate position in the market. The limitation of MBMA is the heterogeneity of the treatment effect. In the near future, MBMA a...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Suzuki A Tags: Yakugaku Zasshi Source Type: research

Role of Academia in Regulatory Science for Global Drug Development.
Abstract As diseases know no national boundaries, drug development must be designed at a global level. Drugs are highly regulated to maximize the benefits to public health, which is assessed on a regional basis. The complexity and diversity of stakeholders increase dramatically once multiple international regions are involved. Each stakeholder in drug development depends on customized criteria to make decisions for its own benefit. Thus, a huge gap exists among drug discovery researchers, developers, clinicians, patients, and regulatory bodies. With reasonable scientific evidence gathered and analyzed, mutual agree...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Tsukamoto K, Takenaka T Tags: Yakugaku Zasshi Source Type: research

Analysis of Spontaneously Reported Adverse Events.
Abstract Observational study is necessary for the evaluation of drug effectiveness in clinical practice. In recent years, the use of spontaneous reporting systems (SRS) for adverse drug reactions has increased and they have become an important resource for regulatory science. SRS, being the largest and most well-known databases worldwide, are one of the primary tools used for postmarketing surveillance and pharmacovigilance. To analyze SRS, the US Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report Database (JADER) are reviewed. Authorized pharmacovigilance...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Nakamura M Tags: Yakugaku Zasshi Source Type: research

Regulatory Science in the Review of Drugs and Medical Devices.
Abstract The review of drugs and medical devices is an integral part of regulatory science. The Pharmaceuticals and Medical Devices Agency (PMDA) evaluates the efficacy, safety, and quality of drugs and medical devices after applications are submitted for regulatory approval. The products are approved when their benefits exceed their risks, i.e., an application is approved if the efficacy of the product in patients was demonstrated and the safety of the product is acceptable in view of its observed benefits. However, drugs and medical devices for which efficacy was not clearly demonstrated in clinical trials makes ...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Koide A Tags: Yakugaku Zasshi Source Type: research

Current Status and Future Prospects of Nonalcoholic Fatty Liver Disease (NAFLD) in Japan-Feedback from Clinical and Basic Researches to Medical Therapy and Pharmacist Activities.
PMID: 27040339 [PubMed - in process] (Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan)
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Tokuyama S, Ih Kim K Tags: Yakugaku Zasshi Source Type: research

An Overview of NAFLD/NASH in Japan.
Abstract Clinical identity of nonalcoholic steatohepatitis (NASH) has established it as a chronic liver disease since the 1990s in the USA and in the 21st century in Japan, although its significance is not well recognized in Japanese society. It is characterized as a chronic liver disease, differentiated from viral liver disease and alcoholic liver disease. Nonalcoholic fatty liver disease (NAFLD) comprises nonalcoholic fatty liver (NAFL) and NASH. NASH is considered to be the hepatic manifestation of a metabolic syndrome. It is understood that among individuals with NAFLD, NAFL is a benign condition, whereas NASH ...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Ryang Kim S, Ih Kim K Tags: Yakugaku Zasshi Source Type: research

Incretin as a Novel Treatment Strategy for NAFLD/NASH.
Abstract Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) have been recognized as metabolic disorders characterized by fatty accumulation in the liver without alcohol consumption. The diseases can cause metabolic syndromes, consisting of obesity, diabetes mellitus (DM), dyslipidemia and hypertension. For the treatment of NAFLD/NASH, losing weight by exercise or diet remains the standard treatment, because no effective pharmacological therapy has yet been developed for NAFLD/NASH. Two incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Takeda Y, Ikeda R, Kondo T Tags: Yakugaku Zasshi Source Type: research

Drug-induced Nonalcoholic Steatohepatitis.
Abstract Nonalcoholic steatohepatitis (NASH) is a chronic progressive liver disease characterized by intense liver steatosis accompanied by hepatocyte destruction, inflammation and fibrous, despite little or no history of alcoholic consumption. There are also cases of drug-induced secondary steatohepatitis. Drug-induced steatohepatitis is a relatively rare type of drug-induced liver disease, but close attention to the possible onset of steatohepatitis is needed when drugs with the potential to induce fatty liver are prescribed for long term use. Estrogen is a factor indispensable to smooth fatty acid β-oxidation i...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Miyamura M, Yokota J, Saibara T Tags: Yakugaku Zasshi Source Type: research

A Future Perspective on the Involvement of n-3 Polyunsaturated Fatty Acid in the Development of Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis.
Abstract Nonalcoholic fatty liver disease (NAFLD) is characterized by the pathological accumulation of fat in the liver in the absence of any other disease related to liver steatosis, which includes a wide spectrum of liver diseases ranging from mild asymptomatic fatty liver to nonalcoholic steatohepatitis (NASH) and cirrhosis. Recently, it was reported that NAFLD is characterized by the impaired bioavailability of liver n-6 and n-3 long-chain polyunsaturated fatty acids (PUFAs). That is, compared with healthy individuals, steatosis and steatohepatitis patients have higher n-6/n-3 PUFA ratios. Furthermore, per rece...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Nakamoto K, Obata T, Hirasawa A, Ih Kim K, Ryang Kim S, Tokuyama S Tags: Yakugaku Zasshi Source Type: research

Characteristics and Functional Roles of Opioids Originally Present in Vivo.
Abstract The characteristics and functional roles of opioids originally present in vivo (endogenous opioids) in guinea-pig ileum were investigated. The release of endogenous opioids was determined by the inhibitory twitch response evoked by 0.1 Hz stimulation after 10 Hz stimulation (post-tetanic twitch inhibition). The effects of peptidase inhibitors increased the post-tetanic twitch inhibition, prevented by β-funaltrexamine and nor-binaltorphimine, which are selective μ- and κ-opioid receptor subtype antagonists, respectively. Dopamine receptor antagonists (haloperidol, sultopride and domperidone) increased th...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Ozaki M Tags: Yakugaku Zasshi Source Type: research

Synthetic Studies of Bioactive Heterocyclic Natural Products and Fused Heterocyclic Compounds Based on the Thermal Electrocyclic or Azaelectocyclic Reaction of 6π-Electron or Aza-6π-electron Systems.
Abstract Since 1979, synthetic studies of bioactive heterocyclic natural products and condensed heteroaromatic compounds based on the thermal electrocyclic reaction of 6π-electron or aza-6π-electron systems incorporating the double bond of the principal aromatic or heteroaromatic ring have been conducted by our research group. In this review, five types of electrocyclic and azaelectrocyclic reaction are described: 1) the synthesis of the carbazole alkaloids hyellazole and 6-chlorohyellazole through the electrocyclic reaction of 2,3-bisalkenylindoles; 2) synthetic studies of the pyridocarbazole alkaloids elliptici...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Hibino S Tags: Yakugaku Zasshi Source Type: research

Molecular Mechanisms of Early-stage Adipocyte Differentiation and Multi-functional Roles of Newly Isolated Adipogenic Factors.
Abstract Obesity is a major risk factor for diabetes, hypertension, hyperlipidemia, and arteriosclerosis. Although the middle and late stages of adipocyte differentiation are well characterized, the earliest step in the differentiation process has remained largely unknown. We isolated 102 genes expressed at the beginning of the differentiation of a mouse preadipocyte cell line, 3T3-L1 cells. Because approximately half of these genes were unknown, we named them factor for adipocyte differentiation (fad) genes. I first show how these genes regulate the early stage of adipocyte differentiation. We next generated fad10...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Imagawa M Tags: Yakugaku Zasshi Source Type: research

Development of Radiolabeled Molecular Imaging Probes for in Vivo Analysis of Biological Function.
Abstract Molecular imaging is a newly emerging field aimed at advancing our understanding of biology and medicine through the noninvasive in vivo investigation of cellular molecular events involved in normal and pathologic processes. In this field, researchers and/or clinicians are combining modern tools of molecular and cell biology with state of the art technology in order to noninvasively image living subjects. Various imaging modalities such as optics (fluorescence and luminescence), nuclear magnetic resonance imaging, ultrasound, and radiation are being used to visually capture and study molecular and cellular...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Ueda M Tags: Yakugaku Zasshi Source Type: research

Exploring New Drug Targets through the Identification of Target Molecules of Bioactive Natural Products.
Abstract With the development of cell biology and microbiology, it has become easy to culture many types of animal cells and microbes, and they are frequently used for phenotypic screening to explore medicinal seeds. On the other hand, it is recognized that cells and pathogenic microbes present in pathologic sites and infected regions of the human body display unique properties different from those under general culture conditions. We isolated several bioactive compounds from marine medicinal resources using constructed bioassay-guided separation focusing on the unique changes in the characteristics of cells and pa...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Arai M Tags: Yakugaku Zasshi Source Type: research

Evaluation of Gastric Mucosal Injury Model Animals of Rebamipide Formulation-Study of Therapeutic Equivalence.
Abstract The introduction of generic drugs is promoted from the perspective of medical economics. In this context, we need to understand not only the bioequivalence of generic drugs specified in "the Guidelines for Bioequivalence Studies of Generic Products", but also formulation properties to consider their effect on pharmacological therapy. We evaluated the pharmaceutical characteristics of rebamipide formulations, a brand-name drug and two generic drugs, and their clinical functionality by using rat models of gastric mucosal injury induced by non-steroidal anti-inflammatory drugs (NSAIDs). Pharmaceutical evaluat...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - April 7, 2016 Category: Drugs & Pharmacology Authors: Abe N, Funato H, Hirata A, Nakai M, Iizuka M, Shiraishi H, Jobu K, Yagi Y, Kadota A, Ogi K, Yokota J, Miyamura M Tags: Yakugaku Zasshi Source Type: research

Dose reduction versus dose-interval prolongation in eribulin mesilate monotherapy in patients with metastatic breast cancer: A retrospective comparative study.
Abstract <bibitem lang="en"> It is often necessary to modify the dose or schedule of Eri (eribulin mesilate) because of adverse events. Therefore, we retrospectively investigated the optimal approach for Eri dose adjustment and/or dosage interval adjustment. Patients who received Eri at the institutions affiliated with the Division of Oncology of the Aichi Prefectural Society of Hospital Pharmacists between July 2011 and November 2013 were enrolled in this study. We compared the group that underwent dose reduction without changes to their dosage interval (dose reduction group) with the group that had a ch...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 31, 2016 Category: Drugs & Pharmacology Authors: Sasaki T, Oshima Y, Mishima E, Ban A, Katsuragawa K, Nagamatsu H, Yoshioka Y, Tsukiyama I, Hisada T, Itakura Y, Mizutani M Tags: Yakugaku Zasshi Source Type: research

New Developments to Break the Limitations of the Integrated Program-Inclusive Reform of Teaching and Learning by the Jigsaw Method.
PMID: 26935071 [PubMed - in process] (Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan)
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Kodama N, Nagai N, Yasuhara T Tags: Yakugaku Zasshi Source Type: research

Introduction and Evaluation of an Integrated Program to Develop Pharmacotherapeutic Management Skills.
Abstract   Pharmacists must be able to select and collect important information for patient care, to accurately assess and monitor the status of patients, to develop care plans, propose optimal formulations, and provide advice to patients about pharmacotherapy. The core curriculum of Japan's pharmacy education model was revised in 2013 based on the "Basic competencies required of a pharmacist" that should be developed by the time of a student's graduation. Specific behavioral objectives to be acquired include competency in "The ability to implement pharmacotherapeutic management", which involves gaining the abili...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Yamashita M, Norose T, Hayakawa T Tags: Yakugaku Zasshi Source Type: research

Theory and Practice of the Constructive Jigsaw Method in Advancing Domain Knowledge and Skills in Parallel.
Abstract   The Learning Sciences constitute a rapidly expanding discipline that focuses on the learning potential of humans. In this paper, I will discuss the particular learning mechanism involved in the concomitant advancement of domain knowledge and 21st century skills, as well as the Constructive Jigsaw Method of knowledge construction through collaboration-that is, collaborative problem solving. An especially important focus on knowledge construction separates routine experts from adaptive experts. While routine experts develop a core set of skills that they apply throughout their lives with increasing effic...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Masukawa H Tags: Yakugaku Zasshi Source Type: research

Jigsaw Method Is Used to Promote a First Year-student's Understanding of Integrated Subjects at Kobe Pharmaceutical University.
Abstract   In the School of Pharmacy, collaborative learning that includes both problem-based learning (PBL) and team-based learning (TBL) methods, has been introduced as an active learning method into the education of first-year pharmacy students. These methods are an educational approach to teaching and learning that involve groups of students working collaboratively to resolve a problem, complete a task, or develop a product. However, these methods might not aid students who focus more on the results than on the problem-solving process. In addition, the self-efficacy and learning motivation of students who dis...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Kodama N, Koyama J Tags: Yakugaku Zasshi Source Type: research

The Synergistic Effect of Problem-based Learning Combined with the Jigsaw Method in a Pharmacotherapy Course.
Abstract   To promote problem-solving ability within a pharmacotherapy course, we developed new problem-based learning (PBL) and information and communication technologies (ICT) support systems, and introduced the "Jigsaw Method," an active learning method in which, similar to parts of a jigsaw puzzle, students are dependent on each other to create the full picture, to succeed. We conducted 10 PBL modules (one case per module), each lasting one week. To encourage constructive group work, information sharing, and student understanding in the individual modules, we implemented a Jigsaw Method-based wiki worksheet s...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Ohtsu F, Nagamatsu T, Nadai M, Hasegawa Y, Goto N Tags: Yakugaku Zasshi Source Type: research

Approach to the Education of Kampo Medicine by Pharmacognosy Faculty.
PMID: 26935076 [PubMed - in process] (Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan)
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Mimaki Y, Kobayashi Y, Makino T Tags: Yakugaku Zasshi Source Type: research

Kampo Education in the Faculty of Pharmaceutical Sciences at Toho University.
Abstract   In the Faculty of Pharmaceutical Sciences at Toho University, Kampo education commenced 40 years ago through a course titeled "Kampo", which has since been renamed as "Kampo Pharmacology". The current university curriculum offers courses in subjects such as Pharmacognosy and Practical Pharmacognosy for sophomores, Kampo Pharmacology for juniors, and Clinical Kampo Medicine for seniors. Kampo Pharmacology is a subject that bridges "Pharmacognosy" to "Clinical Kampo Medicine". The functions of the crude drugs included in Kampo prescriptions are explained both in terms of efficacy from the perspective of ...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Koike K Tags: Yakugaku Zasshi Source Type: research

Approach to Teaching Kampo Medicine at Kyoto Pharmaceutical University.
Abstract   An approach to educating our pharmaceutical students about Kampo medicine in the six-year system of undergraduate pharmacy education at Kyoto Pharmaceutical University is introduced, including the author's opinions. Curriculum revisions have been made in our university for students entering after 2012. In teaching Kampo medicine at present, a medical doctor and an on-site pharmacist share information difficult to give in a lecture with the teaching staff in my laboratory. For example, before the curriculum revision, we conferred with a pharmacist and a doctor in the course "Kampo Medicine A, B" for 4th...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Matsuda H Tags: Yakugaku Zasshi Source Type: research

How to Teach Kampo Medicine in the Age of Internationalization?
Abstract   Given the universal prevalence of complementary and alternative medicines, as well as integrative medicine, the usage of traditional medicine has been gaining in popularity worldwide. Japanese Kampo medicine and traditional Chinese medicine (TCM) are both derived from ancient medicines used in East Asia in the 5th-7th centuries, and have developed independently since the 14th century. Now Kampo medicine and TCM have different theories for the diagnosis and use of crude drugs. Unfortunately, Kampo medicine is not well known in Europe and the Americas; as a matter of practice, TCM is the international st...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Makino T Tags: Yakugaku Zasshi Source Type: research

Education Program of Kampo-medicine for Undergraduates in Preparation for Clinical Setting.
Abstract   Kampo-medicine has become popular in Japanese medical practice combined with western medicine. For example, Daikenchu-To for intestinal obstruction after surgical operation, Shakuyakukanzo-To and Goshajinki-Gan for anti-cancer agents-induced neuropathy, and Yokkan-San for behavioral psychological symptoms of dementia are alternatively used in addition to conventional treatments in Japan. However, combined use of Kampo-medicine and western medicine may cause unexpected adverse events including undesirable drug-drug interactions because Kampo-medicine was not originally developed to be used with western ...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Homma M Tags: Yakugaku Zasshi Source Type: research

Kampo Medicine in the New Model Core Curriculum of Pharmaceutical Education.
Abstract   What should we educate for Kampo medicine in the model core curriculum of pharmaceutical education? The curricular core should be discussed considering the points mentioned below. (1) Positioning of Kampo medicine in the Japanese medical care system. Kampo medicine is an authorized medical care category in the National Health Insurance (NHI) program in Japan. The NHI drug price list carries 148 Kampo formulations. According to the report of the Japan Kampo Medicines Manufacturers Association in 2011, approximately 90% of Japanese physicians prescribe Kampo medicines. (2) Differences between Kampo medic...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Kobayashi Y Tags: Yakugaku Zasshi Source Type: research

Evaluation and Exploring Technique for Drug Target Discovery.
PMID: 26935082 [PubMed - in process] (Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan)
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Kamada H, Inoue T Tags: Yakugaku Zasshi Source Type: research

Development of a Drug Discovery Method Targeted to Stromal Tissue.
Abstract   Several diseases are characterized by alterations in the molecular distribution of vascular structures, presenting the opportunity to use monoclonal antibodies for clinical therapies. This pharmaceutical strategy, often referred to as "vascular targeting", has promise in promoting the discovery and development of selective biological drugs to regulate angiogenesis-related diseases such as cancer. Various experimental approaches have been utilized to discover accessible vascular markers of health and disease at the protein level. Our group has developed a new chemical proteomics technology to identify a...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Kamada H Tags: Yakugaku Zasshi Source Type: research

Biophysical Characterization of Biopharmaceuticals, Including Antibody Drugs.
Abstract   Biopharmaceuticals, including antibody drugs, are now popular because of their high specificity with low adverse effects, especially in the treatment of cancer and autoimmune diseases. However, because the active pharmaceutical ingredients of biopharmaceuticals are proteins, biophysical characterization of these therapeutic proteins should be required. In this manuscript, methods of chemical and physical characterization of therapeutic proteins are described. In terms of chemical characterization, analysis of chemical modifications of the constituent amino acids is explained. Physical characterization ...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Uchiyama S Tags: Yakugaku Zasshi Source Type: research

Structural Study in the Platform for Drug Discovery, Informatics, and Structural Life Science.
Abstract   The Platform for Drug Discovery, Informatics, and Structural Life Science (PDIS), which has been launched since FY2012, is a national project in the field of structural biology. The PDIS consists of three cores - structural analysis, control, and informatics - and aims to support life science researchers who are not familiar with structural biology. The PDIS project is able to provide full-scale support for structural biology research. The support provided by the PDIS project includes protein purification with various expression systems, large scale protein crystallization, crystal structure determinat...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Senda T Tags: Yakugaku Zasshi Source Type: research

Novel Therapeutic Targets for Diseases of Endocrine or Immune System Developed through the Analysis of Cross-talk between Ca(2+) and Disease-related Cell Signaling.
PMID: 26935086 [PubMed - in process] (Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan)
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Ishikawa T, Ohya S Tags: Yakugaku Zasshi Source Type: research

Regulation of Lipid Metabolism by Diacylglycerol Kinases in Pancreatic β-cells.
Abstract   The appropriate secretion of insulin from pancreatic β-cells is essential for regulating blood glucose levels. Glucose-stimulated insulin secretion (GSIS) involves the following steps: Glucose uptake by pancreatic β-cells is metabolized to produce ATP. Increased ATP levels result in the closure of ATP-sensitive K(+) (KATP) channels, resulting in membrane depolarization that activates voltage-dependent Ca(2+) channels to subsequently trigger insulin secretion. In addition to this primary mechanism through KATP channels, insulin secretion is regulated by cyclic AMP and diacylglycerol (DAG), which media...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Kaneko YK, Ishikawa T Tags: Yakugaku Zasshi Source Type: research

Theoretical Investigations into the Quantitative Mechanisms Underlying the Regulation of [cAMP]i, Membrane Excitability and [Ca(2+)]i during GLP-1 Stimulation in Pancreatic β Cells.
Abstract   Upon elevation of plasma glucose concentration, pancreatic β-cells generate bursts of action potentials to induce cyclic changes in [Ca(2+)]i regulating insulin release. Glucose-dependent insulin secretion is synergistically enhanced by glucagon-like peptide-1 (GLP-1), which increases [cAMP]i and activates protein kinase A (PKA) and exchange protein activated by cAMP (Epac). The insulinotropic effect of GLP-1 is mediated, at least in part, by modulating multiple ion channels/transporters at the plasma membrane and ER through PKA- and EPAC-dependent mechanisms, which increase membrane excitability and ...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Takeda Y Tags: Yakugaku Zasshi Source Type: research

Store-operated Calcium Entry into B Cells Regulates Autoimmune Inflammation.
Abstract   Alterations in the cytosolic concentration of calcium ions (Ca(2+)) are important signals for various physiological events. The engagement of B cell receptors (BCR) results in the transient release of Ca(2+) into cytosol from endoplasmic reticulum (ER) stores. In turn, this decrease in ER luminal Ca(2+) concentration triggers the opening of Ca(2+) channels in the plasma membrane, inducing a sustained influx of extracellular Ca(2+) into cells. These processes are referred to as store-operated Ca(2+) entry (SOCE), which is an essential pathway for continuous Ca(2+) signaling. While the ER calcium sensor ...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Baba Y Tags: Yakugaku Zasshi Source Type: research

Physiological Role of K(+) Channels in the Regulation of T Cell Function.
Abstract   Potassium ion (K(+)) channels play an important role in the modulation of calcium ion (Ca(2+)) signaling via control of the membrane potential. In T-lymphocytes, the voltage-gated K(+) channel, KV1.3, and the intermediate-conductance Ca(2+)-activated K(+) channel, KCa3.1, predominantly contribute to K(+) conductance, and are responsible for cell proliferation, differentiation, apoptosis and infiltration. Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, afflicts more than 0.1% of the population worldwide. In the chemically-induced IBD model mouse, an increase in KCa3.1...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Ohya S Tags: Yakugaku Zasshi Source Type: research

Functional Expression of a Ca(2+)-activated Cl(-) Channel Modulator Involved in Ion Transport and Epithelial Cell Differentiation.
Abstract   Cl(-)-permeable channels and transporters expressed on the cell membranes of various mammalian cell types play pivotal roles in the transport of electrolytes and water, pH regulation, cell volume and membrane excitability, and are therefore expected to be useful molecular targets for drug discovery. Both TMEM16A (a possible candidate for Ca(2+)-regulated Cl(-) channels recently identified) and cystic fibrosis transmembrane conductance regulator (CFTR) (or cAMP-regulated Cl(-) channels) have been known to be involved in Cl(-) secretion and reabsorption in the rat salivary gland. Crosstalk between two ty...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Yamazaki J Tags: Yakugaku Zasshi Source Type: research

Development of Molecular Probes for Spatio-temporal Analysis of in Vivo Tumor with Photoacoustic Imaging.
Abstract   Photoacoustic imaging (PA imaging or PAI) has been focused on as a new technique to provide images of high spatial resolution, at depths of up to 5 cm, and the development of novel PAI probes for tumor imaging is of marked interest. Although nanomaterials such as gold nanorods have been reported as PAI probes, dyes are required to aid their ease of preparation, cost-effectiveness, and safety. However, because PAI has relatively low intrinsic sensitivity compared to optical imaging, and requires high-energy laser pulse exposure, an appropriate probe design, high tumor accumulation, and photostability ar...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Onoe S Tags: Yakugaku Zasshi Source Type: research

Methodology for Estimating the Risk of Adverse Drug Reactions in Pregnant Women: Analysis of the Japanese Adverse Drug Event Report Database.
Abstract   Safety information regarding drug use during pregnancy is insufficient. The present study aimed to establish an optimal signal detection method to identify adverse drug reactions in pregnant women and to evaluate information in the Japanese Adverse Drug Event Report (JADER) database between April 2004 and November 2014. We identified reports on pregnant women using the Standardised MedDRA Queries. We calculated the proportional reporting ratio (PRR) and reporting odds ratio (ROR) of the risk factors for the two known risks of antithyroid drugs and methimazole (MMI) embryopathy, and ritodrine and fetal/...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Sakai T, Ohtsu F, Sekiya Y, Mori C, Sakata H, Goto N Tags: Yakugaku Zasshi Source Type: research

Evaluation of the Association of Hand-Foot Syndrome with Anticancer Drugs Using the US Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) Databases.
Abstract   The Japanese Ministry of Health, Labor, and Welfare lists hand-foot syndrome as a serious adverse drug event. Therefore, we evaluated its association with anticancer drug therapy using case reports in the Japanese Adverse Drug Event Report (JADER) and the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). In addition, we calculated the reporting odds ratio (ROR) of anticancer drugs potentially associated with hand-foot syndrome, and applied the Weibull shape parameter to time-to-event data from JADER. We found that JADER contained 338224 reports from April 2004 to November 20...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Sasaoka S, Matsui T, Abe J, Umetsu R, Kato Y, Ueda N, Hane Y, Motooka Y, Hatahira H, Kinosada Y, Nakamura M Tags: Yakugaku Zasshi Source Type: research

Stabilization of the Serum Lithium Concentration by Regulation of Sodium Chloride Intake: Case Report.
Abstract   To avoid fluctuation of the serum lithium concentration (CLi), sodium chloride (NaCl) intake was regulated in oral alimentation. A 62-year-old woman was hospitalized and orally administered 400 mg of lithium carbonate a day to treat her mania. Her CLi was found to be 0.75-0.81 mEq/L. Vomiting made it difficult for the patient to ingest meals orally, and therefore parenteral nutrition with additional oral intake of protein-fortified food was initiated. On day 22, parenteral nutrition was switched to oral alimentation to enable oral intake of food. The total NaCl equivalent amount was decreased to 1.2 g/...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - March 6, 2016 Category: Drugs & Pharmacology Authors: Tomita T, Goto H, Sumiya K, Yoshida T, Tanaka K, Kohda Y Tags: Yakugaku Zasshi Source Type: research

Promotion of Drug Discovery Research by Utilizing Omics Technology.
PMID: 26831783 [PubMed - in process] (Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan)
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - February 3, 2016 Category: Drugs & Pharmacology Authors: Nagano K, Higashisaka K Tags: Yakugaku Zasshi Source Type: research

Challenge to the Development of Molecular Targeted Therapy against a Novel Target Candidate Identified by Antibody Proteomics Technology.
Abstract   Disease proteomics that systemically analyzes and identifies differentially expressed proteins between healthy and diseased samples is a potentially useful approach for obtaining target proteins for drug development. To date, however, very few target proteins have been identified from this field. A key issue that remains to be resolved is how to correctly identify target proteins from a number of potential candidates. To circumvent this problem, we have developed "antibody proteomics technology" in which a single chain Fv phage antibody library is utilized for proteome analysis. Here, we describe the a...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - February 3, 2016 Category: Drugs & Pharmacology Authors: Nagano K Tags: Yakugaku Zasshi Source Type: research

Functional Analysis of GATA4 Complex, a Cardiac Hypertrophy-response Transcriptional Factor, Using a Proteomics Approach.
Abstract   Various stresses on the heart, such as myocardial infarction and hemodynamic overload, activate the sympathetic nervous system and the renin-angiotensin system, ultimately reach the nuclei of cardiomyocytes, and change the pattern of gene expression associated with cardiac hypertrophy. Although present pharmacological therapy for heart failure targets such extracellular molecules, mortality due to heart failure is still high. A zinc finger protein, GATA4, is one of the hypertrophy-responsive transcription factors, forms a functional protein complex with an intrinsic histone acetyltransferase, p300, and...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - February 3, 2016 Category: Drugs & Pharmacology Authors: Sunagawa Y, Katanasaka Y, Wada H, Hasegawa K, Morimoto T Tags: Yakugaku Zasshi Source Type: research

Screening for Potential Drug Targets by Comprehensive Identification of Disease-specific Antigens Incorporated into Immune Complexes in Patients with Immunological Diseases.
Abstract   Our immune system resembles an intelligent security system, which continually monitors for foreign invaders (infectious diseases); however, in some cases, this system recognizes healthy parts as something harmful or foreign and then attacks them (autoimmune diseases). The defining characteristics of an autoimmune disease are the existence of T- and B-cell autoreactivity against self proteins (autoantigens). In addition to autoimmune diseases, aberrant host proteins that occur during a certain state of diseases (e.g., cancer) can be recognized as an autoantigen. Immune complexes (ICs) are produced durin...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - February 3, 2016 Category: Drugs & Pharmacology Authors: Ohyama K Tags: Yakugaku Zasshi Source Type: research

Application of Imaging Mass Spectrometry for Drug Discovery.
Abstract   Imaging mass spectrometry (IMS) can reveal the distribution of biomolecules on tissue sections. In this process, the biomolecules are directly ionized within tissue sections using matrix-assisted laser desorption/ionization, and then their distribution is visualized by pseudo-color based on the relative signal intensity. The biomolecules, such as fatty acids, phospholipids, glycolipids, peptides, proteins, and neurotransmitters, have been analyzed at a spatial resolution of 5 μm. A special instrument for IMS analysis was developed by Shimadzu. The IMS analysis does not require the labeling of biomolec...
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - February 3, 2016 Category: Drugs & Pharmacology Authors: Hayasaka T Tags: Yakugaku Zasshi Source Type: research

Structural Pharmacology for Receptors and Transporters.
PMID: 26831788 [PubMed - in process] (Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan)
Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - February 3, 2016 Category: Drugs & Pharmacology Authors: Shimizu T, Kato H Tags: Yakugaku Zasshi Source Type: research