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Regulatory science

Adam C Fisher, Sau L Lee, Daniel P Harris, Lucinda Buhse, Steven Kozlowski, Lawrence Yu, Michael Kopcha, Janet Woodcock
Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality...
October 20, 2016: International Journal of Pharmaceutics
Sophie Plumejeaud, Amelia Paula Reis, Virginie Tassistro, Carla Patinha, Yves Noack, Thierry Orsière
Due to their behavioral characteristics, young children are vulnerable to the ingestion of indoor dust, often contaminated with chemicals that are potentially harmful. Exposure to potentially harmful elements (PHEs) is currently exacerbated by their widespread use in several industrial, agricultural, domestic and technological applications. PHEs cause adverse health effects on immune and nervous systems and can lead to cancer development via genotoxic mechanisms. The present study is an integrated approach that aims at assessing the genotoxicity of bioaccessible PHEs following ingestion of contaminated house dust...
October 22, 2016: Environmental Geochemistry and Health
Cynthia Van Landingham, Kenneth A Mundt, Bruce C Allen, P Robinan Gentry
Reproducibility and transparency in scientific reporting is paramount to advancing science and providing the foundation required for sound regulation. Recent examples demonstrate that pivotal scientific findings cannot be replicated, due to poor documentation or methodological bias, sparking debate across scientific and regulatory communities. However, there is general agreement that improvements in communicating and documenting research and risk assessment methods are needed. In the case of formaldehyde, the peer-review conducted by a National Academy of Sciences (NAS) Committee questioned the approaches used by the Integrated Risk Information System (IRIS) in developing draft unit risk values...
October 19, 2016: Regulatory Toxicology and Pharmacology: RTP
Steven W Barger
Ask any neuroscientist to name the most profound discoveries in the field in the past 60 years, and at or near the top of the list will be a phenomenon or technique related to genes and their expression. Indeed, our understanding of genetics and gene regulation has ushered in whole new systems of knowledge and new empirical approaches, many of which could not have even been imagined prior to the molecular biology boon of recent decades. Neurochemistry, in the classic sense, intersects with these concepts in the manifestation of neuropeptides, obviously dependent upon the central dogma (the established rules by which DNA sequence is eventually converted into protein primary structure) not only for their conformation but also for their levels and locales of expression...
October 17, 2016: Journal of Neurochemistry
Toshiyoshi Tominaga, Seiko Miyazaki, Yukio Oniyama, Ariel D Weber, Tatsuya Kondo
The Japanese Postmarketing Relief System provides for compensation to patients suffering adverse reactions, based on the acknowledgement that unpredicted adverse events occur inevitably once a drug is marketed. The system also provides new knowledge about the benefit-risk profile of a drug that may be incorporated into product labeling. The system relies on causality assessments that are based on sound clinical pharmacology principles. The system may serve as a model for other countries' healthcare system. This article is protected by copyright...
October 13, 2016: Clinical Pharmacology and Therapeutics
John Fenimore, Howard A Young
Interferon gamma, referred to here as IFN-γ, is a major component in immunological cell signaling and is a critical regulatory protein for overall immune system function. First discovered in 1965 (Wheelock Science 149: (3681)310-311, 1965), IFN-γ is the only Type II interferon identified. Its expression is both positively and negatively controlled by different factors. In this chapter, we will review the transcriptional and post-transcriptional control of IFN-γ expression. In the transcriptional control part, the regular activators and suppressors are summarized, we will also focus on the epigenetic control, such as chromosome access, DNA methylation, and histone acetylation...
2016: Advances in Experimental Medicine and Biology
Thomas S Voss, Mikkel H Vendelbo, Ulla Kampmann, Steen B Pedersen, Thomas S Nielsen, Mogens Johannsen, Mads V Svart, Niels Jessen, Niels Møller
AIMS/HYPOTHESIS: The aims of this study were to determine the role of lipolysis in hypoglycaemia and define the underlying intracellular mechanisms. METHODS: Nine healthy volunteers were randomised to treatment order of three different treatments (crossover design). Treatments were: (1) saline control; (2) hyperinsulinaemic hypoglycaemia (HH; i.v. bolus of 0.1 U/kg insulin); and (3) hyperinsulinaemic euglycaemia (HE; i.v. bolus of 0.1 U/kg insulin and 20% glucose)...
October 12, 2016: Diabetologia
İbrahim Ömer Barlas, Orhan Sezgin, Collet Dandara, Gözde Türköz, Emre Yengel, Zinhle Cindi, Handan Ankaralı, Semra Şardaş
Pharmacogenomics harnesses the utility of a patient's genome (n = 1) in decisions on which therapeutic drugs and in what amounts should be administered. Often, patients with shared ancestry present with comparable genetic profiles that predict drug response. However, populations are not static, thus, often, population mobility through migration, especially enmasse as is seen for refugees, changes the pharmacogenetic profiles of resultant populations and therefore observed responses to commonly used therapeutic drugs...
October 2016: Omics: a Journal of Integrative Biology
Keymanthri Moodley, Shenuka Singh
BACKGROUND: Biobanks are precariously situated at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multi-disciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Each stakeholder is embedded in a unique context and articulates his/her biobanking activities differently. To researchers, biobanks carry enormous transformative potential in terms of advancing scientific discovery and knowledge. However, in the context of power asymmetries in Africa and a distrust in science born out of historical exploitation, researchers must balance the scientific imperative of collecting, storing and sharing high quality biological samples with obligations to donors/participants, communities, international collaborators, regulatory and ethics authorities...
October 10, 2016: BMC Medical Ethics
Lisa Murray, Antonio Arias, Jibin Li, Sid Bhoopathy, Ismael J Hidalgo
To improve the quality of pharmaceutical products in their markets, several Latin American countries have begun to require that new generic products demonstrate bioequivalence against innovator or reference products. However, given the number of products involved, it is not feasible to rely on clinical studies to comply with this requirement. Instead, it makes sense to adopt or develop strategies that are appropriate to the characteristics of the region. To streamline drug development and accelerate patients' access to quality drug products, 15 years ago the United States Food and Drug Administration (FDA) decided to grant exemptions from clinical bioequivalence studies (i...
August 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Harry M T Choi, Colby R Calvert, Naeem Husain, David Huss, Julius C Barsi, Benjamin E Deverman, Ryan C Hunter, Mihoko Kato, S Melanie Lee, Anna C T Abelin, Adam Z Rosenthal, Omar S Akbari, Yuwei Li, Bruce A Hay, Paul W Sternberg, Paul H Patterson, Eric H Davidson, Sarkis K Mazmanian, David A Prober, Matt van de Rijn, Jared R Leadbetter, Dianne K Newman, Carol Readhead, Marianne E Bronner, Barbara Wold, Rusty Lansford, Tatjana Sauka-Spengler, Scott E Fraser, Niles A Pierce
In situ hybridization methods are used across the biological sciences to map mRNA expression within intact specimens. Multiplexed experiments, in which multiple target mRNAs are mapped in a single sample, are essential for studying regulatory interactions, but remain cumbersome in most model organisms. Programmable in situ amplifiers based on the mechanism of hybridization chain reaction (HCR) overcome this longstanding challenge by operating independently within a sample, enabling multiplexed experiments to be performed with an experimental timeline independent of the number of target mRNAs...
October 1, 2016: Development
Georgia Miskell, Jennifer Salmond, David E Williams
Low-cost sensors offer the possibility of gathering high temporal and spatial resolution crowd-sourced data-sets that have the potential to revolutionize the ways in which we understand individual and population exposure to air pollution. However, one of the challenges associated with crowd-sourced data ('citizen science'), often from low-cost sensors, is that citizens may use sites strongly affected by local conditions, limiting the wider significance of the data. This paper examines results from a low-cost network measuring ground-level ozone to evaluate the impact of siting on data quality...
September 29, 2016: Science of the Total Environment
Sergio Cantoreggi
Sergio Cantoreggi speaks to Henry Ireland, Commissioning Editor: Sergio Cantoreggi, PhD, is the Chief Scientific Officer and Global Head of Research and Development of the Helsinn Group, a mid-sized pharmaceutical company headquartered in Lugano, Switzerland, and focused on providing cancer supportive care solutions to oncology patients worldwide. Dr Cantoreggi has overall responsibility for all R&D activities of the Helsinn Group and has contributed to six major regulatory approvals of cancer supportive care agents in the USA, Europe and Japan...
October 3, 2016: Future Oncology
Trusha C Dhanani, Emily H Mantovani, J Rick Turner
All biologically active agents carry the potential to lead to adverse reactions in certain individuals, including serious cardiac adverse reactions. Since 2005, there has been an international regulatory landscape governing the investigation of a new drug's propensity to lead to the polymorphic ventricular tachycardia Torsades de Pointes (Torsades), a rare but potentially fatal occurrence. When a regulatory agency considers it appropriate, warning information is placed in a medicine's patient information leaflet (label) concerning drug-induced QT interval prolongation, a phenomenon associated with Torsades...
September 28, 2016: International Journal of Pharmacy Practice
Maurice Whelan, Chantra Eskes
Validation is essential for the translation of newly developed alternative approaches to animal testing into tools and solutions suitable for regulatory applications. Formal approaches to validation have emerged over the past 20 years or so and although they have helped greatly to progress the field, it is essential that the principles and practice underpinning validation continue to evolve to keep pace with scientific progress. The modular approach to validation should be exploited to encourage more innovation and flexibility in study design and to increase efficiency in filling data gaps...
2016: Advances in Experimental Medicine and Biology
Clare Meernik, Kristen Jarman, Sarah Towner Wright, Elizabeth G Klein, Adam O Goldstein, Leah Ranney
OBJECTIVE: In this paper we synthesize the evidence from eye tracking research in tobacco control to inform tobacco regulatory strategies and tobacco communication campaigns. METHODS: We systematically searched 11 databases for studies that reported eye tracking outcomes in regards to tobacco regulation and communication. Two coders independently reviewed studies for inclusion and abstracted study characteristics and findings. RESULTS: Eighteen studies met full criteria for inclusion...
October 2016: Tobacco Regulatory Science
Hans-Joerg Fugel, Mark Nuijten, Maarten Postma
RATIONALE: Stratified Medicine (SM) is becoming a natural result of advances in biomedical science and a promising path for the innovation-based biopharmaceutical industry to create new investment opportunities. While the use of biomarkers to improve R&D efficiency and productivity is very much acknowledged by industry, much work remains to be done to understand the drivers and conditions that favour using a stratified approach to create economically viable products and to justify the investment in SM interventions as a stratification option...
December 25, 2016: New Biotechnology
Stephen P Arnerić, Richard Batrla-Utermann, Laurel Beckett, Tobias Bittner, Kaj Blennow, Leslie Carter, Robert Dean, Sebastiaan Engelborghs, Just Genius, Mark Forrest Gordon, Janice Hitchcock, June Kaplow, Johan Luthman, Richard Meibach, David Raunig, Klaus Romero, Mahesh N Samtani, Mary Savage, Leslie Shaw, Diane Stephenson, Robert M Umek, Hugo Vanderstichele, Brian Willis, Susan Yule
Alzheimer's disease (AD) drug development is burdened with the current requirement to conduct large, lengthy, and costly trials to overcome uncertainty in patient progression and effect size on treatment outcome measures. There is an urgent need for the discovery, development, and implementation of novel, objectively measured biomarkers for AD that would aid selection of the appropriate subpopulation of patients in clinical trials, and presumably, improve the likelihood of successfully evaluating innovative treatment options...
September 21, 2016: Journal of Alzheimer's Disease: JAD
Kerry L Dearfield, B Bhaskar Gollapudi, Jeffrey C Bemis, R Daniel Benz, George R Douglas, Rosalie K Elespuru, George E Johnson, David J Kirkland, Matthew J LeBaron, Albert P Li, Francesco Marchetti, Lynn H Pottenger, Emiel Rorije, Jennifer Y Tanir, Veronique Thybaud, Jan van Benthem, Carole L Yauk, Errol Zeiger, Mirjam Luijten
For several decades, regulatory testing schemes for genetic damage have been standardized where the tests being utilized examined mutations and structural and numerical chromosomal damage. This has served the genetic toxicity community well when most of the substances being tested were amenable to such assays. The outcome from this testing is usually a dichotomous (yes/no) evaluation of test results, and in many instances, the information is only used to determine whether a substance has carcinogenic potential or not...
September 21, 2016: Environmental and Molecular Mutagenesis
Cui Yang, Si-Dao Zheng, Hong-Jin Wu, Shao-Jun Chen
OBJECTIVE: MicroRNAs (miRNAs or miRs) play critical roles in the fibrotic process in different organs. We summarized the latest research progress on the roles and mechanisms of miRNAs in the regulation of the molecular signaling pathways involved in fibrosis. DATA SOURCES: Papers published in English from January 2010 to August 2015 were selected from the PubMed and Web of Science databases using the search terms "microRNA", "miR", "transforming growth factor β", "tgf β", "mitogen-activated protein kinase", "mapk", "integrin", "p38", "c-Jun NH2-terminal kinase", "jnk", "extracellular signal-regulated kinase", "erk", and "fibrosis"...
2016: Chinese Medical Journal
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