Global Harmonization of Urbanization Measures: Proceed with Care

By 2050, two-thirds of the world’s population is expected to be living in cities and towns, a marked increase from today’s level of 55 percent. If the general trend is unmistakable, efforts to measure it precisely have been beset with difficulties: the criteria defining urban areas, cities and towns differ from one country to the next and can also change over time for any given country. The past decade has seen great progress toward the long-awaited goal of scientifically comparable urbanization measures, thanks to the combined efforts of multiple disciplines. These efforts have been organized around what is termed the “statistical urbanization” concept, whereby urban areas are defined by population density, contiguity and total population size. Data derived from remote-sensing methods can now supply a variety of spatial proxies for urban areas defined in this way. However, it remains to be understood how such proxies complement, or depart from, meaningful country-specific alternatives. In this paper, we investigate finely resolved population census and satellite-derived data for the United States, Mexico and India, three countries with widely varying conceptions of urban places and long histories of debate and refinement of their national criteria. At the extremes of the urban–rural continuum, we find evidence of generally good agreement between the national and remote sensing-derived measures (albeit with variation by country), but identify significant disagreements in the middle ranges where today’s urban policies are often focused.

The First WHO International Standard for Harmonizing the Biological Activity of Bevacizumab

Several Bevacizumab products are approved for clinical use, with many others in late-stage clinical development worldwide. To aid the harmonization of potency assessment across different Bevacizumab products, the first World Health Organization (WHO) International Standard (IS) for Bevacizumab has been developed. Two preparations of a Bevacizumab candidate and comparator were assessed for their ability to neutralize and bind vascular endothelial growth factor (VEGF) using different bioassays and binding assays in an international collaborative study. Relative potency estimates were similar across different assays for the comparator or the duplicate-coded candidate sample. Variability in relative potency estimates was reduced when the candidate standard was used for calculation compared with various in-house reference standards, enabling harmonization in bioactivity evaluations. The results demonstrated that the candidate standard is suitable to serve as an IS for Bevacizumab, with assigned unitages for VEGF neutralization and VEGF binding activity. This standard coded 18/210 was established by the WHO Expert Committee on Biological Standardization, which is intended to support the calibration of secondary standards for product development and lifecycle management. The availability of IS 18/210 will help facilitate the global harmonization of potency evaluation to ensure patient access to Bevacizumab products with consistent safety, quality and efficacy.

Analytical method validation for biomarkers as a drug development tool: points to consider

Biomarkers are an important drug developmental tool. Assessment of quantitative analytical methods of biomarkers is not included in any regulatory documents in Japan. Use of biomarkers in clinical evaluations and supporting the post-marketing evaluation of drug efficacy and/or adverse reactions requires assessment and full validation of analytical methods for these biomarkers. The Biomarker Analytical Method Validation Study Group is a research group in Japan comprising industry and regulatory experts. Group members discussed and prepared this ‘points to consider document’ covering measurements of endogenous metabolites/peptides/proteins by ligand binding assays and chromatographic methods with or without mass spectrometry. We hope this document contributes to the global harmonization of biomarker assay validation.

Toward Global Harmonization of Training and Certification of Specialists in Laboratory Animal Veterinary Medicine

Laboratory animal medicine (LAM) is a corner stone of animal-based research and has been a veterinary specialty for over60 y. Today 5 Colleges of LAM (American, European, Japanese, Korean, and Indian) that certify specialists (Diplomates) inLAM are members of the International Association of Colleges of LAM (IACLAM). Goals of IACLAM are to support the development of new Colleges of LAM, to harmonize expectations for the knowledge and skills of newly certified LAM Diplomate, and to harmonize the standards (best practices) for training and examination of candidates among the member Colleges. IACLAM recently conducted an in-depth review and comparison of oversight, training, credentialing, and examination standards in the 5 Colleges as part of an initiative to create a framework for harmonization and consistency for these activities across the 5 Colleges. The process has led to an agreement on recommendations for knowledge and skill requirements for a newly certified Diplomate, as described by each College in a detailed role delineation document (RDD). The RDD is based on task analyses of the work responsibilities of laboratory animal veterinary Diplomates. This agreement is an important step toward the goal of global harmonization of LAM Diplomate training. Further efforts are planned for areas such as training, research, publication, and examination. This paper describes the role and content of the RDD and lists the differences and similarities among the RDDs of 5 Colleges of LAM.

TRANSFORMATION OF MODERN METHODS OF FINANCIAL ANALYSIS OF CONSOLIDATED FINANCIAL STATEMENTS OF ENTERPRISES

The main goal of this research is to identify those indicators of reporting of associations of enterprises that change their nature or content under the influence of consolidation against the background of the application of IFRS, as well as areas of transformation of methods of its analysis. The article reveals the essence of consolidated financial statements and the peculiarities of the process of its formation. Financial information becomes the main tool of communication and formation of business image of enterprises in the market environment. The carrier of such information is the financial statements, which are compiled according to international standards, which are constantly progressing and reforming. As a result, business owners have more and more freedom in its formation, despite the global harmonization of the list of indicators and their content, which allows you to present your business in a favorable light and assess those aspects of contractors that are most important for further cooperation. The main information needs of groups of users of consolidated financial statements are considered. The authors specify the areas of analysis of the financial and property condition of the group of enterprises according to the consolidated financial statements and substantiate the reasons for the need for their transformation. Some aspects of the analysis of the consolidated financial statements are characterized, which do not allow to form a correct idea of the financial and property condition of its individual elements. The accounting components of the consolidated financial statements are determined, which may distort the results of the coefficient analysis and indicators of their modification. The peculiarities of the analysis of such reporting are due to the transformations of the accounting content of its indicators - the reflection of contingent assets, liabilities, risks, possible costs and revenues. All components of analysis methods - horizontal, vertical, trend, and especially - coefficient - undergo certain changes. The need to disseminate cost-oriented approaches in the analysis of consolidated financial statements is substantiated.