Results 81 to 90 of about 9,693 (238)

Evaluating effectiveness of risk minimization through healthcare professional surveys: A review of post‐authorization studies, 2022–2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Risk minimization measures (RMMs) are key regulatory tools to ensure safe medicinal product use. Regulatory guidelines recommend pre‐specifying the targets, or ‘thresholds’, for assessing RMM effectiveness. We aimed to review recent industry‐sponsored post‐authorization safety studies (PASS) that evaluated the effectiveness of RMMs ...
Kexin Zhu, William A. Blumentals, Froilan G. Celzo, G. Caleb Alexander, Lingyun Zhou, Juhaeri Juhaeri, Corinne Jouquelet‐Royer, Jian‐Yu E   +7 more
wiley   +1 more source

Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway

British Journal of Clinical Pharmacology, EarlyView.
Aim This study aimed to compare how Norwegian healthcare professionals (HCPs) and consumers reported the same adverse event (AE) following immunization with vaccines against COVID‐19 during the COVID‐19 pandemic. Specifically, we aimed to compare the extent to which HCPs and consumers reported information relevant for assessing the causal relationship ...
Tommy Emil Dzus, Johaina Sarrage, Hilde Samdal, François Montastruc, Elena Rocca   +4 more
wiley   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

The impact of medication shortages on paediatric care: A retrospective impact analysis

British Journal of Clinical Pharmacology, EarlyView.
Aims Medication shortages are a growing global concern, with potentially greater consequences in paediatric patients because of the limited availability of safe, evidence‐based and appropriately formulated medication. This study aimed to evaluate the impact of medication shortages on paediatric patients by assessing the suitability and safety of ...
Maaike Johanna Rutten ‐ van Kranenburg, Laurens Christiaan van Rijn, Elisabeth Johanna Ruijgrok, Sinno Henricus Paulus Simons, Brigitta Carolina Maria Witjes, Jan‐Dietert Christoffer Brugma, Robert Bernard Flint   +6 more
wiley   +1 more source

An open repository of COVID-19 vaccine mandate studies with a worked scoping review of quasi-experimental evidence

npj Vaccines
Vaccine mandates were widely implemented against COVID-19, and a large and multidisciplinary literature has emerged as a result, covering fields such as epidemiology, economics, ethics, and law.
Fabio I. Martinenghi, Tanka Prashad Ojha, Amy Thomasson, Bianca Devsam, Shevaun Drislane, Sophie Vasiliadis, Chiara Berardi, Aregawi Gebremariam, Alessia Dipalma, Teresa Gavaruzzi, Jeremy K. Ward, Francesco Paolucci, Margie Danchin, Mesfin Genie, Katie Attwell, Christopher C. Blyth   +15 more
doaj   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

British Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz   +7 more
wiley   +1 more source

Enhancing the Secretion Systems: Genetic Engineering of Super Bioagents for Effective Plant Disease Control

Biotechnology and Bioengineering, EarlyView.
Genetic engineering (GE) overcomes BCA limits, enabling robust, scalable crop protection. “Super Bioagents” (SBs) use optimized SSs to enhance bioactive molecule delivery. Optimizing SSs enhance precise, sustainable effector deployment for stable disease suppression. SBs use microbiome‐informed design for scalable, next‐gen sustainable crop protection.
Michael Dare Asemoloye
wiley   +1 more source

Characterization of Immune Responses to RBD‐SD1 Nanoparticle Vaccines Derived From ACE2‐Capable HKU5‐CoV‐2, NeoCoV, and HKU5 Merbecoviruses

Biotechnology and Bioengineering, EarlyView.
SpyCatcher‐mi3 nanoparticles presenting HKU5, NeoCoV, and HKU5‐CoV‐2 RBD‐SD1 induced strong, cross‐reactive IgG responses in immunized mice. The surrogate virus neutralization test demonstrated strong activity in sera from homologous vaccination. ABSTRACT Recent discoveries of merbecoviruses such as HKU5, NeoCoV, and HKU5‐CoV‐2 that use angiotensin ...
Peter J. Halfmann, Jeong Soo Lee, Augustine Duffy, Tong Wang, Bingcheng Huang, James Z. Kurdi, Ajay Inampudi, Natasha Chen, Elizabeth Frimpong, Carmen Rai, Yoshihiro Kawaoka, Ravi S. Kane   +11 more
wiley   +1 more source

User privacy prevention model using supervised federated learning‐based block chain approach for internet of Medical Things

CAAI Transactions on Intelligence Technology, EarlyView., 2023
Abstract This research focuses on addressing the privacy issues in healthcare advancement monitoring with the rapid establishment of the decentralised communication system in the Internet of Medical Things (IoMT). An integrated blockchain homomorphic encryption standard with an in‐build supervised learning‐based smart contract is designed to improvise ...
Chandramohan Dhasarathan, Mohammad Kamrul Hasan, Shayla Islam, Salwani Abdullah, Shailesh Khapre, Dalbir Singh, Abdulaziz A. Alsulami, Ali Alqahtani   +7 more
wiley   +1 more source