Association between Residential Greenness and Allostatic Load: A Cohort Study.

The association between residential greenness and allostatic load (AL), a marker of composite physiological burden and predictor of chronic disease, remains understudied. This study comprised 212,600 UK Biobank participants recruited over 2007 and 2010 at the baseline. Residential greenness was modeled as the normalized difference vegetation index (NDVI) from high spatial resolution (0.

Quantifying the embodied carbon saving potential of recycling construction and demolition waste in the Greater Bay Area, China: Status quo and future scenarios.

Comparing with the enduring efforts to reduce carbon emissions in design, construction, and operation stages of a construction project, less attention has been paid to emission abatement potential in the end-of-life stage, particularly by recycling waste generated by construction and demolition (C&D) activities. This research aims to cover this knowledge void by quantifying the embodied carbon saving potential of recycling C&D waste. It does so by adopting a Life Cycle Assessment (LCA) and choosing the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) in South China for a case study.

Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance.

The principles of comparability assessments have been accepted globally as offering sensitive and reliable tools with which to evaluate potential changes to biologics that may arise either through processing changes or through the creation of a copy (biosimilar) by a different sponsor. The comparability approach has evolved through systematic advances in four areas: clear and convergent guidelines for evaluation of potential changes to biologics; risk-based systems of weighting analytical data; progressive improvements in analytical methods; and advanced understanding of post-translational modifications. Routine regulatory expectations for clinical equivalence data are being reevaluated, as they seldom contribute to the assessment of similarity.

An Efficient Development Paradigm for Biosimilars.

The current development paradigm for biosimilars required by regulators in highly regulated jurisdictions is derived from the development of novel drugs and is unnecessarily burdensome and inefficient. It requires the accumulation of data from analytical, nonclinical (including in vivo studies in some jurisdictions), and clinical studies (including powered efficacy studies in most cases); this paradigm is known as 'totality of evidence' (ToE) and does not admit a conclusion of biosimilarity from analytical data alone. The record of biosimilar approvals in these jurisdictions shows that no biosimilar candidate that has been found highly similar to its reference in analytical and pharmacokinetic studies has failed to be approved.

From Broken Windows to Perceived Routine Activities: Examining Impacts of Environmental Interventions on Perceived Safety of Urban Alleys.

In high-density cities around the world, alleys are common but neglected spaces that are perceived as unsafe. While cities have invested resources in environmental interventions to improve safety in urban allies, it is not clear how these interventions impact perceived safety. We review two important criminology theories that discuss the environmental and social factors that lead to crime: the Broken Windows Theory and the Routine Activity Theory.

Cities for global health.

In the first of a new series of articles on the role of cities in health, call for greater action to reduce health inequalities within cities

The Environmental Exposures and Inner- and Intercity Traffic Flows of the Metro System May Contribute to the Skin Microbiome and Resistome.

The skin functions as the primary interface between the human body and the external environment. To understand how the microbiome varies within urban mass transit and influences the skin microbiota, we profiled the human palm microbiome after contact with handrails within the Hong Kong Mass Transit Railway (MTR) system. Intraday sampling time was identified as the primary determinant of the variation and recurrence of the community composition, whereas human-associated species and clinically important antibiotic resistance genes (ARGs) were captured as p.

A 'Global Reference' Comparator for Biosimilar Development.

Major drug regulators have indicated in guidance their flexibility to accept some development data for biosimilars generated with reference product versions licensed outside their own jurisdictions, but most authorities require new bridging studies between these versions and the versions of them licensed locally. The costs of these studies are not trivial in absolute terms and, due to the multiplier effect of required repetition by each biosimilar sponsor, their collective costs are substantial. Yet versions of biologics licensed in different jurisdictions usually share the same development data, and any manufacturing changes between versions have been justified by a rigorous comparability process.

Toward a Metagenomic Understanding on the Bacterial Composition and Resistome in Hong Kong Banknotes.

Currency is possibly one of the main media transmitting pathogens and drug resistance due to its wide circulation in daily life. In this study, we made a comprehensive characterization of the bacterial community present on banknotes collected from different geographical regions of Hong Kong (HK) by performing characterization of the bacterial presence and resistome profile, as well as metagenomic analysis including microbial diversity, the prevalence of potential pathogens, the dissemination potential of antibiotic-resistance genes (ARGs), among others. When comparing the bacterial community of HK banknotes with other HK environmental samples, including water and marine sediment, we revealed that HK banknotes cover nearly 50% of total genera found in all the environmental samples, implying that banknotes harbor diverse bacteria originated from a variety of environments.

Efficacy of sumatriptan tablets in migraineurs self-described or physician-diagnosed as having sinus headache: a randomized, double-blind, placebo-controlled study.

Background: Many patients and physicians interpret episodic headache in the presence or absence of nasal symptoms as "sinus' headache, while ignoring the possible diagnosis of migraine.

Objective: The purpose of this study was to assess the efficacy and tolerability of sumatriptan succinate 50-mg tablets in patients with migraine presenting with "sinus" headache.

Methods: A randomized, double-blind, placebo-controlled, multicenter study was conducted in adult (aged 18-65 years) migraine patients presenting with self-described or physician-diagnosed "sinus" headache.

A cost-effectiveness approach to the qualification and acceptance of biomarkers.

The flow of new medicines to patients depends on the development of new biomarkers and their correct interpretation, yet there are no widely accepted and practically applicable criteria that facilitate adequate biomarker qualification. As a result, case-by-case qualifications are based on subjective assessments that do not lead to optimal decisions for patients, which have contributed to the 'stagnation' in drug productivity identified by the FDA. An alternative is to qualify biomarkers in terms of cost effectiveness using a set of principles that enable the evaluation of biomarkers even with incomplete knowledge.

Returning genetic research results to individuals: points-to-consider.

This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non-validated or hypothesis-generating).

Genetic patent protection in the pharmaceutical and biotechnology industries.

Without patent protection, biomedical progress would be severely diminished. Conditions under the current patent regime are characterized by rapid advancement made possible by cooperative licensing, collaboration and partnerships between and among various entities, and the drive to bring successful products to market both in order to make profits and to further the cause of humanity. The financial advantages associated with patent-driven corporate participation are the lifeline of innovation.

Long-term tolerability of sumatriptan nasal spray in adolescent patients with migraine.

Objective: This 1-year, open-label, multicenter study was designed to assess the long-term tolerability and efficacy of sumatriptan nasal spray 20 mg in adolescent patients with migraine.

Methods: A prospective, multicenter, open-label study was conducted in patients aged 12 to 17 years who were allowed to treat an unlimited number of migraines at severe, moderate, or mild pain intensity with sumatriptan nasal spray for up to 1 year. All patients started the study at the 20-mg dose of sumatriptan nasal spray.

Prevalence of migraine in patients with a history of self-reported or physician-diagnosed "sinus" headache.

Background: Symptoms referable to the sinus area are frequently reported during migraine attacks, but are not recognized in diagnostic criteria. Underrecognition of migraine may be partly attributed to a variable clinical presentation, and migraines with "sinus" symptoms contribute to this problem. This study was conducted to determine the prevalence of migraine-type headache (International Headache Society [IHS]-defined migraine without aura [IHS 1.

GW320659 for the treatment of attention-deficit/hyperactivity disorder in children.

Objective: To assess the safety, tolerability, and efficacy of GW320659, a chemically novel inhibitor of norepinephrine and dopamine reuptake, in pediatric attention-deficit/hyperactivity disorder (ADHD).

Method: This was a multicenter, open-label, dose-titration study of seven daily dose levels of GW320659: 1.25, 2.