Development and licensing of bio-pharmaceuticals

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Driving licensing renewal policy using neural network-based probabilistic decision support system

This paper investigates neural network-based probabilistic decision support system to assess drivers' knowledge for the objective of developing a renewal policy of driving licences. The probabilistic model correlates drivers' demographic data to their results in a simulated written driving exam (SWDE). The probabilistic decision support system classifies drivers' into two groups of passing and failing a SWDE. Knowledge assessment of drivers within a probabilistic framework allows quantifying and incorporating uncertainty information into the decision-making system. The results obtained in a Jordanian case study indicate that the performance of the probabilistic decision support systems is more reliable than conventional deterministic decision support systems. Implications of the proposed probabilistic decision support systems on the renewing of the driving licences decision and the possibility of including extra assessment methods are discussed.

Innovation in the pharmaceutical industry:a study of the effects of regulation on the U.K. pharmaceutical industry

A history of government drug regulation and the relationship between the pharmaceutical companies in the U.K. and the licensing authority is outlined. Phases of regulatory stringency are identified with the formation of the Committees on Safety of Drugs and Medicines viewed as watersheds. A study of the impact of government regulation on industrial R&D activities focuses on the effects on the rate and direction of new product innovation. A literature review examines the decline in new chemical entity innovation. Regulations are cited as a major but not singular cause of the decline. Previous research attempting to determine the causes of such a decline on an empirical basis is given and the methodological problems associated with such research are identified. The U.K. owned sector of the British pharmaceutical industry is selected for a study employing a bottom-up approach allowing disaggregation of data. A historical background to the industry is provided, with each company analysed or a case study basis. Variations between companies regarding the policies adopted for R&D are emphasised. The process of drug innovation is described in order to determine possible indicators of the rate and direction of inventive and innovative activity. All possible indicators are considered and their suitability assessed. R&D expenditure data for the period 1960-1983 is subsequently presented as an input indicator. Intermediate output indicators are treated in a similar way and patent data are identified as a readily-available and useful source. The advantages and disadvantages of using such data are considered. Using interview material, patenting policies for most of the U.K. companies are described providing a background for a patent-based study. Sources of patent data are examined with an emphasis on computerised systems. A number of searches using a variety of sources are presented. Patent family size is examined as a possible indicator of an invention's relative importance. The patenting activity of the companies over the period 1960-1983 is given and the variation between companies is noted. The relationship between patent data and other indicators used is analysed using statistical methods resulting in an apparent lack of correlation. An alternative approach taking into account variations in company policy and phases in research activity indicates a stronger relationship between patenting activity, R&D Expenditure and NCE output over the period. The relationship is not apparent at an aggregated company level. Some evidence is presented for a relationship between phases of regulatory stringency, inventive and innovative activity but the importance of other factors is emphasised.

Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine

Objective of the study To determine the extent and nature of unlicensed/off-label prescribing patterns in hospitalised children in Palestine. Setting Four paediatric wards in two public health system hospitals in Palestine [Caritas children’s hospital (Medical and neonatal intensive care units) and Rafidia general hospital (Medical and surgical units)]. Method A prospective survey of drugs administered to infants and children <18 years old was carried out over a five-week period in the four paediatric wards. Main outcome measure Drug-licensing status of all prescriptions was determined according to the Palestinian Registered Product List and the Physician’s Desk Reference. Results Overall, 917 drug prescriptions were administered to 387children. Of all drug prescriptions, 528 (57.5%) were licensed for use in children; 65 (7.1%) were unlicensed; and 324 (35.3%) were used off-label. Of all children, 49.6% received off-label prescriptions, 10.1% received unlicensed medications and 8.2% received both. Seventy-two percent of off-label drugs and 66% of unlicensed drugs were prescribed for children <2 years. Multivariate analysis showed that patients who were admitted to the neonatal intensive care unit and infants aged 0–1 years were most likely to receive a greater number of off-label or unlicensed medications (OR 1.80; 95% CI 1.03–3.59 and OR 1.99; 95% CI 0.88–3.73, respectively). Conclusion The present findings confirmed the elevated prevalence of unlicensed and off-label paediatric drugs use in Palestine and strongly support the need to perform well designed clinical studies in children.

Intellectual property asset management:how to identify, protect, manage and exploit intellectual property within the business environment

In the new ‘knowledge-intensive economies’ Intellectual assets increasingly play a key part on balance sheets. There is an increasing global awareness that in order to promote innovation and the growth of the economy, businesses must fully recognise and exploit their intellectual assets. A company’s ability to innovate rapidly and successfully is now regarded as essential and most breakthroughs are made by Small and Medium-sized Enterprises (SMEs), usually with no in-house legal professionals to help them. It is essential that those working with or creating intellectual property rights (IPR) are aware of the basics of Intellectual Property Law. Intellectual Property Asset Management provides business and management students at all levels with an accessible-straight-forward explanation of what the main Intellectual Property rights are and how these rights are protected. Locating the subject squarely in a business context and using case studies and examples throughout drawn from a wide range of business organisations, it explains how an organisation can exploit their rights through licensing, franchising and other means in order to make the best possible use of their IP assets. This book will provide students with: • the basic Intellectual Property law knowledge needed to identify a potential IP issue • the tools and understanding to assess an IP breach • the ability to identify where the problem cannot be solved in house and where expert legal assistance is required • the knowledge required to work effectively with lawyers and other legal professionals to achieve the desired outcome

Using SPICE for power system simulations

Power system simulation software is a useful tool for teaching the fundamentals of power system design and operation. However, existing commercial packages are not ideal for teaching work-based students because of high-cost, complexity of the software and licensing restrictions. This paper describes a set of power systems libraries that have been developed for use with the free, student-edition of a Micro-Cap Spice that overcomes these problems. In addition, these libraries are easily adapted to include power electronic converter based components into the simulation, such as HVDC, FACTS and smart-grid devices, as well as advanced system control functions. These types of technology are set to become more widespread throughout existing power networks, and their inclusion into a power engineering degree course is therefore becoming increasingly important.