Results 81 to 90 of about 27,161 (265)

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

Impact of the pancreatic enzyme replacement therapy (PERT) shortage on prescribing in England: Analysis of national data

British Journal of Clinical Pharmacology, EarlyView.
Aim Pancreatic enzyme replacement therapy (PERT) is essential for the management of pancreatic exocrine insufficiency. Since June 2023, the United Kingdom has been affected by a global shortage of PERT. We investigated the impact of this shortage on national prescribing trends for Creon, Nutrizym, Pancrex and Pangrol.
Teena S. Varghese, Mary E. Phillips, Louis Fisher, Helen Fitt, Adam Frampton, Christopher Wood, Agnieszka Lemanska   +6 more
wiley   +1 more source

A comparative analysis of three pharmacovigilance system assessment tools.

PLoS ONE
BackgroundThree key tools are currently available for assessing pharmacovigilance systems at the national level: the Indicator-Based Pharmacovigilance Assessment Tool (IPAT), the World Health Organization (WHO) Pharmacovigilance Indicators, and the ...
Muhammad Akhtar Abbas Khan, Jude Nwokike, Asim Rauf, Zaheer-Ud-Din Babar   +3 more
doaj   +1 more source

Pharmacovigilance-related events, disease burden and overall efficiency of care in european countries, 1990-2021

Frontiers in Pharmacology
ObjectivesThis study aimed to evaluate and compare the disease burden of pharmacovigilance-related events in European countries, to identify the factors related to pharmacovigilance-related inputs in various countries, and to analyze and compare the ...
Lin Yin, Lin Yin, Shuzhi Lin, Shuzhi Lin, Qian Liu, Qian Liu, Xiaoying Zhu, Xiaoying Zhu, Wei Liu, Wei Liu, Yifang Shen, Yifang Shen, Zimeng Li, Zimeng Li, Bianling Feng, Bianling Feng   +15 more
doaj   +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

Current practice and guideline adherence in renal dose adjustment for patients with chronic kidney disease: A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Aims To quantify prescribing adherence to renal dosing recommendations in adults with chronic kidney disease (CKD; Stage 3 and above) and to evaluate the clinical consequences of non‐adherence. Methods This systematic review and meta‐analysis was conducted in accordance with PRISMA 2020 guidelines and registered in PROSPERO (CRD42025620883).
Hager ElGeed, Ahmed Tehemar, Mohamed Gasimelseed, Ahmed Gharaibeh, Muhammad Abdul Hadi, Kazeem Yusuff, Amani Zidan, Ahmed Awaisu   +7 more
wiley   +1 more source

A Pharmacovigilance Study Using Tracer Techniques

Advances in Pharmacoepidemiology & Drug Safety, 2014
Objective: To identify adverse drug reactions by using a comprehensive trigger tool method. To categorize the identified adverse drug reactions based upon their Probability, Severity, Harm and Preventability by using different scales. Methods: A single-center, Cross-sectional, observational study based on medication and laboratory trigger tool ...
openaire   +1 more source

Safety outcomes of antidiabetic medications: A comprehensive review of the EU summaries of product characteristics and international clinical practice guidelines

British Journal of Clinical Pharmacology, EarlyView.
Aims Information on the safety profile of antidiabetic medications is essential for informed treatment decisions in type 2 diabetes mellitus. Although this information is available in regulatory documents of individual drugs, a comprehensive overview across all approved antidiabetics is lacking.
David Liang, Daniala L. Weir, Safana Thevasahayam, Vera H. M. Deneer, Arno Siebes, Helga Gardarsdottir   +5 more
wiley   +1 more source

PHARMACOVIGILANCE IN THE ELDERLY (PHARE STUDY) [PDF]

Innovation in Aging, 2017
P. Gareri, A. Castagna, M. Staglianò, A. Corsonello, M. Rocca, G. De Sarro   +5 more
openaire   +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