A Comprehensive Review of Data Governance Literature

Organizations have found that seemingly tedious data problems are fundamentally business problems, and cannot be solved by the IT group alone. Public organizations routinely store large volumes of data about its citizens and while analysis of this data can improve decision-making and better address individual needs, this fails due to a lack of data governance. Data governance has received growing attention from both practitioners and academics as a promising approach to solving organizational data issues. This paper presents a review of data governance literature, classifying authors, research disciplines, methods and related theoretical fields, providing researchers with an overview of this emerging field. The paper is concluded by suggesting four areas for future development of the data governance field in the context of the public sector

Data governance: Organizing data for trustworthy Artificial Intelligence

The rise of Big, Open and Linked Data (BOLD) enables Big Data Algorithmic Systems (BDAS) which are often based on machine learning, neural networks and other forms of Artificial Intelligence (AI). As such systems are increasingly requested to make decisions that are consequential to individuals, communities and society at large, their failures cannot be tolerated, and they are subject to stringent regulatory and ethical requirements. However, they all rely on data which is not only big, open and linked but varied, dynamic and streamed at high speeds in real-time. Managing such data is challenging. To overcome such challenges and utilize opportunities for BDAS, organizations are increasingly developing advanced data governance capabilities. This paper reviews challenges and approaches to data governance for such systems, and proposes a framework for data governance for trustworthy BDAS. The framework promotes the stewardship of data, processes and algorithms, the controlled opening of data and algorithms to enable external scrutiny, trusted information sharing within and between organizations, risk-based governance, system-level controls, and data control through shared ownership and self-sovereign identities. The framework is based on 13 design principles and is proposed incrementally, for a single organization and multiple networked organizations.NORTE-01-0145- FEDER-000037

FDA Critical Path Initiatives: Opportunities for Generic Drug Development

FDA’s critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document “Critical Path Opportunities for Generic Drugs” that identified some of the specific challenges in the development of generic drugs. The key steps in generic product development are usually characterization of the reference product, design of a pharmaceutically equivalent and bioequivalent product, design of a consistent manufacturing process and conduct of the pivotal bioequivalence study. There are several areas of opportunity where scientific progress could accelerate the development and approval of generic products and expand the range of products for which generic versions are available, while maintaining high standards for quality, safety, and efficacy. These areas include the use of quality by design to develop bioequivalent products, more efficient bioequivalence methods for systemically acting drugs (expansion of BCS waivers, highly variable drugs), and development of new bioequivalence methods for locally acting drugs

In Vivo Methods for the Assessment of Topical Drug Bioavailability

This paper reviews some current methods for the in vivo assessment of local cutaneous bioavailability in humans after topical drug application. After an introduction discussing the importance of local drug bioavailability assessment and the limitations of model-based predictions, the focus turns to the relevance of experimental studies. The available techniques are then reviewed in detail, with particular emphasis on the tape stripping and microdialysis methodologies. Other less developed techniques, including the skin biopsy, suction blister, follicle removal and confocal Raman spectroscopy techniques are also described