Results 61 to 70 of about 802 (167)

Current and future perspective of registry utilisation for regulatory settings in Japan: pharmaceuticals, medical devices, and regenerative medicine products

Journal of Pharmaceutical Policy and Practice
Considerable attention has been paid to the utilisation of real-world data throughout the lifecycle of pharmaceuticals, medical devices, and regenerative products.
Chieko Ishiguro, Yasutomo Teshima, Harumasa Nakamura   +2 more
doaj   +1 more source

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

British Journal of Clinical Pharmacology, EarlyView.
Abstract This review focuses on the development of radiopharmaceutical imaging agents and radioligand therapeutics for paediatric use. Nuclear medicine plays an important role in the diagnosis and treatment of various childhood conditions, including cancers, infections and brain disorders.
Justin L. Hay, Amandine Manon, Hunter Stephens, S. Y. Amy Cheung, Bart de Keizer, Erik T. te Beek   +5 more
wiley   +1 more source

Good scientific practice of using worldwide post-marketing surveillance data to ensure safety with HAALI BDDE cross-linked hyaluronic acid fillers

Drugs in Context
Background: Aliaxin fillers (HAALI), produced by IBSA Farmaceutici Italia SrL (Italy), are biodegradable, non-pyrogenic, 1,4-butanediol diglycidyl ether cross-linked hyaluronic acid (HA) hydrogels.
Hema Sundaram, Beatriz Molina, Editta Buttura da Prato, Gabriel Siquier-Dameto, Michela Zazzaron, Clara Cigni, Franco Grimolizzi   +6 more
doaj   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Phase IV of Drug Development

Perspectives in Clinical Research, 2010
Not all Phase IV studies are post-marketing surveillance (PMS) studies but every PMS study is a phase IV study. Phase IV is also an important phase of drug development.
Viraj Suvarna
doaj  

Safety concerns reported by coroners following fentanyl patch fatalities in England, Wales and Northern Ireland between 1997 and 2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim To identify safety concerns reported by coroners following fentanyl patch‐related deaths in England, Wales and Northern Ireland, and determine differences in coronial reporting. Methods A systematic case series linking the National Programme on Substance Use Mortality (NPSUM) and the Preventable Deaths Tracker (PDT) (https ...
Eman Mshari, Caroline S. Copeland, Georgia C. Richards   +2 more
wiley   +1 more source

POST MARKETING SURVEILLANCE STUDY ON RISPERIDONE IN PATIENTS SUFFERING FROM SCHIZOPHRENIA

National Journal of Medical Research, 2011
Schizophrenia is one of the commonest psychiatric ailments. It has been estimated that approximately 1% of the population and 15% of the adults suffers from this disease.
J R Zaveri, Vipul Chaudhari
doaj  

Adverse events in bedaquiline‐ and pretomanid‐based regimens for drug‐resistant tuberculosis from trial, implementation and pharmacovigilance studies

British Journal of Clinical Pharmacology, EarlyView.
Abstract The availability of safety data, particularly concerning adverse events (AEs) associated with the new shorter regimen for drug‐resistant tuberculosis (TB) containing a bedaquiline–pretomanid‐based regimen, is still limited. This systematic review aims to provide a comprehensive and updated analysis of AEs related to this new regimen by ...
Nisa Maria, Annisa Lazuardi Larasati, Indri Yuliani Hamdani, Jin‐Gun Cho, Jan‐Willem C. Alffenaar   +4 more
wiley   +1 more source

Practice, knowledge and attitude of physicians and pharmacists towards the spontaneous reporting system of adverse drug reactions in Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Introduction Introduction Reporting adverse drug reactions (ADRs) is essential for detecting drug risks. Despite legal obligations in Switzerland, underreporting remains an issue. This study assessed practice, knowledge and attitudes towards the spontaneous ADR reporting system among physicians and pharmacists.
Fiona A. Strobel, Thomas Stammschulte, Patrick E. Beeler   +2 more
wiley   +1 more source

Evaluating the Potential Infectious Risk Profile of Biologics in Chronic Rhinosinusitis With Nasal Polyposis

International Forum of Allergy &Rhinology, EarlyView.
Maxime Fieux, Philippe Gevaert, Leigh J. Sowerby   +2 more
wiley   +1 more source