Results 81 to 90 of about 6,606,497 (285)

Problems of post‐marketing surveillance. [PDF]

British Journal of Clinical Pharmacology, 1983
W M, Castle, J T, Nicholls, C C, Downie
openaire   +2 more sources

Translational development of crisugabalin for neuropathic pain

British Journal of Clinical Pharmacology, EarlyView.
Abstract Crisugabalin (HSK16149) is a next‐generation α2δ ligand developed to preserve the mechanistic rationale of gabapentinoids while refining target engagement and exposure‐related tolerability constraints. We performed a translational review of molecular/structural studies, in vivo pharmacology and behavioural safety assessments, phase I clinical ...
Rafael Batista João, Jilly Octoria Tagore Chan, Luísa Mendes Araújo, André Batista João, Raquel Mattos Filgueiras, Paulo César Ragazzo   +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  

Analysis of clinical investigation (device) initial submissions received by the Medicines and Healthcare products Regulatory Agency between January 2022 and December 2025

British Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to analyse clinical investigation‐device initial submissions received by the MHRA between January 2022 and December 2025. Methods Data on submissions were extracted from the clinical investigations unit data bank; software as medical devices were not included. The predefined primary end‐point was submission type.
Andrea Manfrin, Mark Grumbridge, Daniel Hill, Crina Cacou, Graham Warren, James Pound, Jacob George, Alejandro F. Frangi   +7 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

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

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

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