Results 71 to 80 of about 22,949 (256)

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

Post‐marketing drug surveillance. [PDF]

British Journal of Clinical Pharmacology, 1978
R J, Walden, B N, Prichard
openaire   +2 more sources

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

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  

Sequential analysis for post-marketing drug safety surveillance using routinely collected electronic healthcare data: a scoping review

Therapeutic Advances in Drug Safety
Background: Routinely collected electronic healthcare data have created new opportunities for active, near real-time post-marketing drug safety surveillance.
Yixin Sun, Qian Ding, Hongting Nie, Peng Guo   +3 more
doaj   +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

Patients’ motives for participating in active post‐marketing surveillance

Pharmacoepidemiology and Drug Safety, 2012
ABSTRACTPurposeWeb‐based intensive monitoring is a method to actively collect information about adverse drug reactions (ADRs) using patients as a source of information. To date, little is known about patients’ motivation to participate in this kind of active post‐marketing surveillance (PMS).
Harmark, Linda, Lie-Kwie, Miguel, Berm, Lisette, de Gier, Han, van Grootheest, Kees   +4 more
openaire   +3 more sources

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

Reception Baseline Assessment and ‘small acts’ of micro‐resistance

British Educational Research Journal, EarlyView.
Abstract In September 2021, following the global COVID‐19 pandemic, the Department for Education introduced a national standardised digital Reception Baseline Assessment (RBA) for all English 4‐year‐old children. We analyse RBA and its associated Quality Monitoring Visits, as a further intensification of the new public management of early years ...
Guy Roberts‐Holmes, Diana Sousa, Siew Fung Lee   +2 more
wiley   +1 more source

A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records

Open Access Journal of Clinical Trials, 2011
Keiichi Yamamoto1, Shigemi Matsumoto2, Kazuhiro Yanagihara2, Satoshi Teramukai1, Masanori Fukushima1,2,31Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan; 2Outpatient Oncology Unit,
Yamamoto K, Matsumoto S, Yanagihara K, Teramukai S, Fukushima M   +4 more
doaj