Article
Engineering, Chemical
Olivia McDermott, Jiju Antony, Michael Sony, Stephen Daly
Summary: This study investigates the barriers to implementing continuous improvement methodologies in the Irish Pharma industry, finding that a highly regulated environment is perceived as a significant obstacle. However, a majority of participants still utilize continuous improvement methods, driven by a desire to improve productivity and quality.
Review
Pharmacology & Pharmacy
Ebtisam Alharbi, Rigina Skeva, Nick Juty, Caroline Jay, Carole Goble
Summary: The FAIR (findable, accessible, interoperable and reusable) principles are guidelines that aim to increase the effective use of scientific research data. Adhering to these principles in pharmaceutical research and development (R&D) can maximize the value of data assets, but comes with challenges and costs. The 'FAIR-Decide' framework uses business analysis techniques to estimate costs and benefits, providing support for decision-making on FAIRification in the pharmaceutical R&D industry and integration into data management strategies.
DRUG DISCOVERY TODAY
(2023)
Article
Medicine, Research & Experimental
Jan Turner, Pandora Pound, Carla Owen, Isobel Hutchinson, Marina Hop, David Y. S. Chau, Lady V. Barrios Silva, Mike Coleman, Audrey Dubourg, Lorna W. Harries, Victoria Hutter, J. Gerry Kenna, Volker M. Lauschke, Winfried Neuhaus, Clive Roper, Paul B. Watkins, Jonathan Welch, Laura Rego Alvarez, Katy Taylor
Summary: New approach methodologies (NAMs) based on human biology can evaluate the adverse biological effects of pharmaceuticals and chemicals. However, their use in drug development for human safety assessment is still unclear. A series of workshops with international experts was conducted to identify feasible NAMs and discuss their application in specific safety assessment contexts. The resulting maps provide guidance on selecting appropriate NAMs and address scientific requirements for safety assessment in various organ systems.
ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION
(2023)
Article
Green & Sustainable Science & Technology
Abdullah Baz, Riaz Ahmed, Suhel Ahmad Khan, Sudesh Kumar
Summary: This study explores the gaps between security risks and threats assessments for personalized healthcare services based on Industry 5.0, and proposes a framework for security risk assessment in the healthcare industry. The research highlights the importance of identifying security risks and threats in order to ensure optimal security for the healthcare system.
Article
Environmental Sciences
Cecilie Rendal, Johannes Witt, Thomas G. Preuss, Roman Ashauer
Summary: The use of toxicokinetic-toxicodynamic (TKTD) modeling in regulatory risk assessment of plant protection products is becoming more popular. The Simplified Algae Model Extended (SAM-X) can be used for regulatory submission in Tier 2C, providing thousands of virtual laboratory mimic simulations that predict the effects of time-variable exposures. This study demonstrates that for 72-h toxicity tests, the nutrient dynamics in the SAM-X model are not necessary.
ENVIRONMENTAL TOXICOLOGY AND CHEMISTRY
(2023)
Article
Public, Environmental & Occupational Health
Mirco Peron, Simone Arena, Nicola Paltrinieri, Fabio Sgarbossa, Georgios Boustras
Summary: After the Seveso disaster, there has been a growing awareness of the potential impacts of similar accidents in process establishments. The main research focus has been on preventing and mitigating the consequences of these accidents, leading to the development of various risk assessment methodologies. This study aims to provide an up-to-date and comprehensive overview of the risk assessment methodologies for handling hazardous substances in the European industry.
Review
Pharmacology & Pharmacy
Mauricio A. Garcia, Felipe Varum, Jozef Al-Gousous, Michael Hofmann, Susanne Page, Peter Langguth
Summary: This article reviews the latest techniques for bio-predictive dissolution testing of colon-targeted products. Conventional methods overlook physiological factors, while bio-predictive testing can accelerate product development and regulatory approval.
Article
Pharmacology & Pharmacy
Tjitske M. van der Zanden, Miriam G. Mooij, Nienke J. Vet, Antje Neubert, Wolfgang Rascher, Florian B. Lagler, Christoph Male, Helene Grytli, Thomas Halvorsen, Matthijs de Hoog, Saskia N. de Wildt
Summary: Drugs are granted licenses for use after thorough scientific assessments of risks and benefits, but many drugs relevant to children lack such evaluations. This lack of evaluation may result in unknown harm to children. Therefore, a comprehensive assessment of risks and benefits is necessary to ensure safe and effective pharmacotherapy.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2021)
Review
Pharmacology & Pharmacy
Cathy Anne Pinto, Zaneta Balantac, Shahrul Mt-Isa, Xinyue Liu, Oswaldo L. Bracco, Harrison Clarke, Tommi Tervonen
Summary: The policies of EMA and FDA aim to strengthen benefit-risk capabilities, but how they are implemented in regulatory practice is unclear. A systematic review of oncology drug approvals between 2015 and 2020 revealed that the standard of evidence for benefit-risk assessments has diversified over time, but patient experience and real-world data are rarely included in these assessments despite policy goals to increase their use.
DRUG DISCOVERY TODAY
(2023)
Article
Engineering, Civil
Wei Ming Dan Chia, Sye Loong Keoh, Cindy Goh, Christopher Johnson
Summary: This paper highlights the importance of Risk Assessment (RA) in ensuring the safety of Autonomous Driving Systems (ADS) in urban cities. It acknowledges the maturity of ADS technologies and the need for safe deployment on public roads. However, it also identifies the complexity of ADS compared to traditional vehicles and the limitations of existing standards in validating functional safety. The paper provides a comparison of existing RA methodologies and recommends potential solutions for AV RA to meet ISO 26262 and ISO/PAS 21448 standards.
IEEE TRANSACTIONS ON INTELLIGENT TRANSPORTATION SYSTEMS
(2022)
Article
Chemistry, Multidisciplinary
Efthymios N. Lallas, Ilias Santouridis, Georgios Mountzouris, Vassilis C. Gerogiannis, Anthony Karageorgos
Summary: This paper proposes a method that utilizes semantic web technologies to represent pharmaceutical manufacturing data in a unified manner and evaluate their ALCOA compliance systematically. The method uses semantic annotations and reasoning to assess ALCOA compliance.
APPLIED SCIENCES-BASEL
(2022)
Article
Green & Sustainable Science & Technology
Yeneneh Tamirat Negash, Liria Salome Calahorrano Sarmiento, Ming-Lang Tseng, Korbkul Jantarakolica, Kimhua Tan
Summary: This study provides a hierarchical framework with a focus on customer empathy, innovation, and stakeholder interaction for the assessment of an SPPS in the pharmaceutical industry. Practices such as research and development expertise, process innovation, and product innovation can enhance efficiency in decision-making. The proposed framework serves as a guideline for firms looking to implement sustainable product-service systems.
JOURNAL OF CLEANER PRODUCTION
(2021)
Article
Pharmacology & Pharmacy
Mercy Owusu-Asante, Delese Mimi Darko, Stuart Walker, Sam Salek
Summary: This study evaluates the current status and challenges of the ECOWAS-MRH initiative in the pharmaceutical industry, and proposes strategies to strengthen the initiative. The harmonization of registration requirements is reported as a major benefit, reducing application burdens and saving time and resources. However, challenges include a lack of centralized submission and tracking, regulatory performance differences, insufficient applicant information, and a preference for other regulatory pathways.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Business
Siying Cai, Wenzhong Zhu, Yuting Wang
Summary: Corporate social responsibility (CSR) is a concept that involves addressing environmental, economic, and social issues by considering social or environmental concerns. This research aims to analyze the evaluative language used in pharmaceutical industry CSR reports and understand how it helps companies communicate with stakeholders and bridge the legitimacy gap. The study demonstrates that report authors tend to use positive resources to evaluate themselves, while negative resources are used to characterize others. Additionally, the use of affect resources differs significantly between organizations, although both rely on appreciation resources to maintain or repair their legitimacy. The results also highlight ethical responsibility as a key focus in pharmaceutical industry CSR reports.
CORPORATE SOCIAL RESPONSIBILITY AND ENVIRONMENTAL MANAGEMENT
(2023)
Article
Toxicology
Nicholas Ball, Remi Bars, Philip A. Botham, Andreea Cuciureanu, Mark T. D. Cronin, John E. Doe, Tatsiana Dudzina, Timothy W. Gant, Marcel Leist, Bennard van Ravenzwaay
Summary: The long-term investment in new approach methodologies (NAMs) has led to a consensus on how to assess the safety of chemicals using in silico, in vitro, and targeted in vivo sources. However, the adoption of this methodology for regulatory purposes is slow. In this study, a framework incorporating these methods was developed to meet the requirements of REACH. The framework allows for a transparent and phased introduction of NAMs, providing the same level of public health protection using fewer animals, time, and resources.
ARCHIVES OF TOXICOLOGY
(2022)