New Drug Research, The Extraterritorial Application of FDA Regulations, and the Need for International Cooperation

In recent years, U.S. pharmaceutical companies have expanded their new drug trials beyond the borders of the United States. While the companies have a variety of reasons for making this move, among them may be a desire to avoid Food and Drug Administration (FDA) regulation and monitoring. Lack of adequate supervision of drug trials conducted in the developing world endangers both the subjects of the tests and the consumers in the United States. It is unclear whether the FDA can execute regulatory and supervisory authority abroad. The FDA statute does not clearly authorize the agency to regulate extraterritorially. Applying the presumption against extraterritoriality, the FDA should not, therefore, be allowed to regulate drug testing abroad. Exceptions to the presumption might, however, be applicable. Regardless of whether U.S. courts allow the FDA to bring actions against companies for violations abroad, international cooperation is needed to control drug testing

Estimating moose population parameters from aerial surveys

Successful moose management depends on knowledge of population dynamics. The principal parameters required are size, rate of change, recruitment, sex composition, and mortality. Moose management in Alaska has been severely hampered by the lack of good estimates of these parameters, and unfortunately, this lack contributed to the decline of many Alaskan moose populations during the 1970s (e.g., Gasaway et al. 1983). The problems were: (1) population size not adequately estimated, (2) rapid rates of decline not acknowledged until populations were low, (3) meaningful recruitment rates were not available in the absence of good population estimates, and (4) calf and adult mortality rates were grossly underestimated. Frustration of moose managers working with inadequate data led to development of aerial survey procedures that yield minimally biased, sufficiently precise estimates of population parameters for most Alaskan moose management and research. This manual describes these procedures. Development of these procedures would have been impossible without the inspiration, support, advice, and criticism of many colleagues. We thank these colleagues for their contributions. Dale Haggstrom and Dave Kelleyhouse helped develop flight patterns, tested and improved early sampling designs, and as moose managers, put these procedures into routine use. Pilots Bill Lentsch and Pete Haggland were instrumental in developing and testing aerial surveying techniques. Their interest and dedication to improving moose management made them valuable allies. Statisticians Dana Thomas of the University of Alaska and W. Scott Overton of Oregon State University provided advice on variance approximations for the population estimator. Warren Ballard, Sterling Miller, SuzAnne Miller, Doug Larsen, and Wayne Kale tested procedures and provided valuable criticisms and suggestions. Jim Raymond initially programmed a portable calculator to make lengthy calculation simple, fast, and error-free. Angie Babcock, Lisa Ingalls, Vicky Leffingwell, and Laura McManus patiently typed several versions of this manual. John Coady and Oliver Burris provided continuous moral and financial support for a 3-year project that lasted 6 years. Joan Barnett, Rodney Boetje, Steven Peterson, and Wayne Regelin of the Alaska Department of Fish and Game provided helpful editorial suggestions in previous drafts. Finally, we thank referees David Anderson of the Utah Cooperative Wildlife Research Unit, Vincent Schultz of Washington State University, and James Peek, E. "Oz" Garton, and Mike Samuel of the University of Idaho whose comments and suggestions improved this manual. This project was funded by the Alaska Department of Fish and Game through Federal Aid in Wildlife Restoration Projects W-17-9 through W-22-1

First Records for \u3ci\u3eAeshna Sitchensis\u3c/i\u3e (Odonata: Aeshnidae) and \u3ci\u3eEnallagma Clausum\u3c/i\u3e (Odonata: Coenagrionidae), and a Northwestern Record for the State-Endangered \u3ci\u3eSomatochlora Incurvata\u3c/i\u3e (Odonata: Corduliidae) in Wisconsin

While surveying for Odonata in coastal peatlands and associated shoreline areas adjacent to Lake Superior in Wisconsin, we documented populations of two new state record species, the zig-zag darner (Aeshna sitchensis Hagen) and the alkali bluet (Enallagma clausum Morse). We also located a robust population of the state-endangered incurvate emerald (Somatochlora incurvata Walker) at the northwestern edge of the known range of this species. Adults and exuviae of A. sitchensis and S. incurvata were found at an insular fen on Stockton Island, Ashland County, within the Apostle Islands National Lakeshore (AINL). Breeding of both species had occurred in areas of the fen where small pools had dried by summer. Additionally, a single adult male A. sitchensis was collected in the City of Superior in Douglas County. Adult E. clausum were found at two sites: on the Lake Superior beach near the mouth of the Sand River within the AINL in Bayfield County, and along the northeast shore of Allouez Bay in the City of Superior in Douglas County

rNAV 2.0: a visualization tool for bacterial sRNA-mediated regulatory networks mining

Data description. Data description and availability, and parameter settings used in this study. (PDF 101 kb

First Records for \u3ci\u3eAeshna Sitchensis\u3c/i\u3e (Odonata: Aeshnidae) and \u3ci\u3eEnallagma Clausum\u3c/i\u3e (Odonata: Coenagrionidae), and a Northwestern Record for the State-Endangered \u3ci\u3eSomatochlora Incurvata\u3c/i\u3e (Odonata: Corduliidae) in Wisconsin

While surveying for Odonata in coastal peatlands and associated shoreline areas adjacent to Lake Superior in Wisconsin, we documented populations of two new state record species, the zig-zag darner (Aeshna sitchensis Hagen) and the alkali bluet (Enallagma clausum Morse). We also located a robust population of the state-endangered incurvate emerald (Somatochlora incurvata Walker) at the northwestern edge of the known range of this species. Adults and exuviae of A. sitchensis and S. incurvata were found at an insular fen on Stockton Island, Ashland County, within the Apostle Islands National Lakeshore (AINL). Breeding of both species had occurred in areas of the fen where small pools had dried by summer. Additionally, a single adult male A. sitchensis was collected in the City of Superior in Douglas County. Adult E. clausum were found at two sites: on the Lake Superior beach near the mouth of the Sand River within the AINL in Bayfield County, and along the northeast shore of Allouez Bay in the City of Superior in Douglas County

Importance of replication in analyzing time-series gene expression data: Corticosteroid dynamics and circadian patterns in rat liver

<p>Abstract</p> <p>Background</p> <p>Microarray technology is a powerful and widely accepted experimental technique in molecular biology that allows studying genome wide transcriptional responses. However, experimental data usually contain potential sources of uncertainty and thus many experiments are now designed with repeated measurements to better assess such inherent variability. Many computational methods have been proposed to account for the variability in replicates. As yet, there is no model to output expression profiles accounting for replicate information so that a variety of computational models that take the expression profiles as the input data can explore this information without any modification.</p> <p>Results</p> <p>We propose a methodology which integrates replicate variability into expression profiles, to generate so-called 'true' expression profiles. The study addresses two issues: (i) develop a statistical model that can estimate 'true' expression profiles which are more robust than the average profile, and (ii) extend our previous micro-clustering which was designed specifically for clustering time-series expression data. The model utilizes a previously proposed error model and the concept of 'relative difference'. The clustering effectiveness is demonstrated through synthetic data where several methods are compared. We subsequently analyze <it>in vivo </it>rat data to elucidate circadian transcriptional dynamics as well as liver-specific corticosteroid induced changes in gene expression.</p> <p>Conclusions</p> <p>We have proposed a model which integrates the error information from repeated measurements into the expression profiles. Through numerous synthetic and real time-series data, we demonstrated the ability of the approach to improve the clustering performance and assist in the identification and selection of informative expression motifs.</p

The Digital Observatory for Protected Areas (DOPA) Explorer 1.0

The Digital Observatory for Protected Areas (DOPA) has been developed to support the European Union’s efforts in strengthening our capacity to mobilize and use biodiversity data, information and forecasts so that they are readily accessible to policymakers, managers, experts and other users. Conceived as a set of web based services, DOPA provides a broad set of free and open source tools to assess, monitor and even forecast the state of and pressure on protected areas at local, regional and global scale. DOPA Explorer 1.0 is a web based interface available in four languages (EN, FR, ES, PT) providing simple means to explore the nearly 16,000 protected areas that are at least as large as 100 km2. Distinguishing between terrestrial, marine and mixed protected areas, DOPA Explorer 1.0 can help end users to identify those with most unique ecosystems and species, and assess the pressures they are exposed to because of human development. Recognized by the UN Convention on Biological Diversity (CBD) as a reference information system, DOPA Explorer is based on the best global data sets available and provides means to rank protected areas at the country and ecoregion levels. Inversely, DOPA Explorer indirectly highlights the protected areas for which information is incomplete. We finally invite the end-users of DOPA to engage with us through the proposed communication platforms to help improve our work to support the safeguarding of biodiversity.JRC.H.5-Land Resources Managemen

The Digital Observatory for Protected Areas (DOPA) Explorer 1.0

The Digital Observatory for Protected Areas (DOPA) has been developed to support the European Union’s efforts in strengthening our capacity to mobilize and use biodiversity data, information and forecasts so that they are readily accessible to policymakers, managers, experts and other users. Conceived as a set of web based services, DOPA provides a broad set of free and open source tools to assess, monitor and even forecast the state of and pressure on protected areas at local, regional and global scale. DOPA Explorer 1.0 is a web based interface available in four languages (EN, FR, ES, PT) providing simple means to explore the nearly 16,000 protected areas that are at least as large as 100 km2. Distinguishing between terrestrial, marine and mixed protected areas, DOPA Explorer 1.0 can help end users to identify those with most unique ecosystems and species, and assess the pressures they are exposed to because of human development. Recognized by the UN Convention on Biological Diversity (CBD) as a reference information system, DOPA Explorer is based on the best global data sets available and provides means to rank protected areas at the country and ecoregion levels. Inversely, DOPA Explorer indirectly highlights the protected areas for which information is incomplete. We finally invite the end-users of DOPA to engage with us through the proposed communication platforms to help improve our work to support the safeguarding of biodiversity