De Montfort University

The research team will employ computer simulations and experiments to allow companies to design and test IR tablets virtually. Credit: De Montfort University. A collaborative research project between De Montfort University Leicester (DMU) and the University of Surrey in the UK has received a grant to help streamline and reduce costs for pharmaceutical companies in developing new medicines. The project, which received funding of more than £1.1m from the Engineering and Physical Sciences Research Council (EPSRC), focuses on improving the development process for immediate release (IR) tablets, which are crucial for delivering fast-acting medication. DMU professors Mingzhong Li and Walkiria Schlindwein have been awarded £674,890 while their counterparts at the University of Surrey have received £409,247. Li stated: “Tablets account for the vast majority of medicines that our health systems rely on and provide the quality of life we have come to expect of the past century. “This demands a detailed understanding of the interrelationship between physical properties of the ingredients, drug/excipient interaction within blended powder and tabletted formulations, and subsequently the underlying disintegration and dissolution mechanisms that occur when the tablet comes in contact with physiological fluid. See Also: AI database to bolster research for GLP1-RAs as precision medicines UK Government expands opioid overdose treatment access “In this project, we are aiming to develop fundamental understandings of how a tablet releases the active pharmaceutical ingredients in the gastrointestinal tract, leading to a step change in our ability to model, analyse and design the pharmaceutical products.” The project aims to create models that can predict accurately the way medicines are released from IR tablets. The research team will employ computer simulations and experiments to develop models that could simplify the tablet development process and allow pharmaceutical companies to design and test IR tablets virtually. This innovation has the potential to expedite the introduction of new drugs to the market, reducing both the time and cost associated with drug development. Involving collaboration between experts from different universities, the project will run from 1 July 2024 to 30 June 2027.

Legal restrictions placed on the amount of time young people in China can play video games may be less effective than originally thought, a new study has revealed. Legal restrictions placed on the amount of time young people in China can play video games may be less effective than originally thought, a new study has revealed. To investigate the effectiveness of the policy, a team of researchers led by the University of York, analysed over 7 billion hours of playtime data from tens of thousands of games, with data drawn from over two billion accounts from players in China, where legal restrictions on playtime for young people have been in place since 2019. The research team, however, did not find evidence of a decrease in heavy play of games after these restrictions were put in place. The video games industry has witnessed a surge in popularity, and as many as 4 billion people are now estimated to engage in gaming worldwide each year. Many countries across the globe have expressed concerns about the number of hours young people spend playing video games and the potential impact of this on wellbeing. In response to these concerns, in 2019 China restricted playtime for people under 18. China is one of the first countries to explore legal means of restricting gameplay for young people with the aim of limiting the potential risks of gaming to wellbeing, and the policy was assumed to be effective, with some bodies suggesting that it had resolved issues relating to disordered gaming. Dr David Zendle, from the University of York's Department of Computer Science, said: "Policymakers around the world have been discussing how to understand the impact of video gameplay, particularly on young people, for some time now, and how to ensure a healthy relationship with games. The UK government, for example, has recently issued guidelines for high quality research into gaming and wellbeing to inform future decision making. "The restrictions in China allowed us to look, for the first time, at the real behavioural impact of regulation on reducing the time people spent in gameplay and whether this policy had the desired effect. "We found no evidence of a decrease in the prevalence of heavy play and more research is needed to understand why, but the work certainly highlights that this kind of analysis can be useful for policymakers, anywhere in the world, to move forward confidently in discussions around regulations in the digital space." Dr Catherine Flick, from De Montfort University, said: "We hope that the work will provide a case study for understanding how a government's policy decisions affect -- or do not affect -- the lives of real people on a grand scale, and form a blueprint for future data-led public policy evaluation to lead to better and more effective policymaking." This research represents the first time big data has been used to evaluate the effect of public policy in games. Leon Y. Xiao, from the IT University of Copenhagen, emphasised the importance of independent research when evaluating policymaking: "Given previous industry-affiliated claims that this policy has 'solved video game addiction,' it made sense in a Chinese context to consider scaling it up to other domains. In fact, the Chinese government is currently consulting on limiting screen time amongst young people by law, although parents may override those limits. "These results now suggest that the potential effectiveness of such policymaking could benefit from being monitored by non-industry-affiliated, independent researchers." The research is published at a time when there are growing global efforts to regulate technology and its impact on society. The UK's Online Safety Bill, the European Parliament's rules on in-game purchases, and the ongoing focus on regulating social media in the USA, are current examples of how governments worldwide are seeking to address digital challenges, particularly concerning the protection of children. The research suggests a path forward for such efforts. Professor Anders Drachen, from the University of Southern Denmark, emphasised the potential of this data-led approach in evaluating technology regulation, stating "It is now possible to tractably analyse billions of hours of digital behavioural data, which can help lead to a better understanding of how to develop effective policies around online behaviour. This study is an example of how we can use such data to assess whether a policy actually impacts citizens or companies in the way it is intended to." The research is published in the journal, Natural Human Behaviour. and was conducted by members of the Digital Observatory Research Cluster, a non-profit cross-institutional academic research group focused on delivering data-driven insights and observations about digital life.

DUBLIN, Oct. 20, 2022 /PRNewswire/ -- The "Effective Technology Transfer Training Course" conference has been added to ResearchAndMarkets.com's offering. Technology transfer (TT) is an increasingly important part of the pharmaceutical industry, with companies expanding the use of third parties for both development and manufacture. There are few formal guidelines around this subject, but regulators expect companies to get it right for both internal and external transfers. Poorly run transfers can be costly and impact product quality, whereas well-run transfers bring business benefits and assure product quality. Attending this highly practical course will give participants the tools to help guide them through achieving successful transfers. It is applicable to those making transfers from development to commercial, from commercial to commercial, for scale-up, analytical methods or for 'virtual' companies. The programme covers pharmaceutical products, including ATMPs and combination products, but does not include medical devices. Benefits of attending: Understand that technology transfer (TT) is part of the product life cycle, supported by the pharmaceutical quality system Know where TT is covered in ICH, FDA, EU, WHO and PIC/S guidelines Learn the key steps for successful transfers Know how to engage sending and receiving units (SU and RU) for TT Understand how product and process understanding enables TT Apply tools such as quality risk management and clarify risks involved in TT Understand how change should be handled, eg facility and equipment differences between SU and RU; scale-up Learn how analytical method transfers are an integral part of TT Recognise how TT impacts a wide range of companies from innovative to generic, including development, manufacturing, major corporations and 'virtual' companies Realise how significant business benefits emerge from successful TT Understand TT for pharmaceutical products, including combination products and ATMPs Who Should Attend: This seminar will be of particular interest to all those from the pharmaceutical industry working in: Development Manufacturing Engineering Quality The following personnel from the pharmaceutical and biopharmaceutical industries will also find it beneficial: Pharmacists Scientists Engineers Quality assurance professionals Quality control managers Late-stage product and process development engineers, scientists, pharmacists Technology scale-up and transfer managers Validation and qualification specialists Risk management specialists Operation managers Key Topics Covered: Regulatory guidance and business drivers for TT ICH Q10 Exercise 1 - What Makes a Successful TT? Industry guidance for sending and receiving units (SU and RU) Knowledge What do SU and RU need? Exercise 2: Knowledge Science and risk-based approaches - part one Science and risk-based approaches - part two Equipment and utilities Exercise 3: Equipment at SU and RU Quality risk management Project management steps for TT - part one Exercise 4 - Case Study - Fishbone for TT Project management steps for TT - part two Exercise 5: Case Study - Organising TT Validation and qualification Exercise 6: SU And RU Analytical method transfer - part one Analytical method transfer - part two Enabling successful TT - 'softer' issues Speakers Bruce Davis Associate NSF Healthsciences Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Quality Risk Management, GMP for Engineers and other related topics. He has run many training events for companies both in the UK and internationally and is often invited to speak at international conferences. He is past Chair of ISPE International Board of Directors and led their case study for practical implementation of QbD. He co-chaired the team updating their Technology Transfer (TT) Guide and carries out training for them and other organisations. He is a professional engineer and has many years' experience in the pharmaceutical industry and a wide international knowledge, and understanding of current regulatory approaches in the above topics for both US and EU. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, facilitating QbD and leading changes to qualification practices. He played a leadership role to set up De Montfort University's MSc distance learning course in QbD. He is an Associate to NSF Healthsciences, and for them has carried out consultancy and training in the above topic areas, and also for driving down human error. For more information about this conference visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets