Results 121 to 130 of about 3,567,700 (291)

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +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

Food Not Bombs : Feeding Africa

One of a series of posters painted by Food Not Bombs co-founder Keith McHenry to illustrate Food Not Bombs gatherings, tours or other actions. This poster depicts buildings or towns from various cultures, people holding a "Food Not Bombs" banner, and ...
McHenry, Keith, 1957-
core   +1 more source

Clinical relevance of pharmacogenomic information for improving prescribing practices in acutely admitted older medical patients

British Journal of Clinical Pharmacology, EarlyView.
Aims Safe prescribing and effective medication review during acute hospitalization depends on accurate information about liver and kidney function because these organs are responsible for the elimination of most medications. While estimates for kidney function are widely used, comparable markers of hepatic drug‐metabolizing capacity are not routinely ...
Louise Westberg Strejby Christensen, Anne Kirstine Boas, Emilie Clausen, Nicoline Elers Koch, Anne Byriel Walls, Lotte Stig Nørgaard, Michael Asger Andersen, Anissa Aharaz, Rikke Lundsgaard Nielsen, Olivia Bornæs, Juliette Tavenier, Baker Nawfal Jawad, Helle Gybel Juul‐Larsen, Esben Iversen, Ove Andersen, Lona Louring Christrup, Kim Peder Dalhoff, Morten Baltzer Houlind   +17 more
wiley   +1 more source

Food Not Bombs : The 1996 Food Not Bombs world gathering - Atlanta

, 1996
One of a series of posters painted by Food Not Bombs co-founder Keith McHenry to illustrate Food Not Bombs gatherings, tours or other actions. This poster depicts a park with a "Liberation Radio" booth, a band playing on a stage, an Olympics building ...
McHenry, Keith, 1957-
core   +1 more source

Gabapentin as an add‐on analgesic to morphine in paediatric patients with chronic pain

British Journal of Clinical Pharmacology, EarlyView.
Aims Off‐label use of gabapentin for the treatment of chronic pain in children has increased over the last decade, with multiple clinical trials evaluating its role pain management and potential opioid‐sparing effects. To date, however, these studies appear to rely on empirical evidence without further consideration of pharmacokinetic‐pharmacodynamic ...
Paul Healy, Mariagrazia Felisi, Adriana Ceci, Oscar Della Pasqua, on Behalf of the GAPP Consortium, Corinne Alberti, Donato Bonifazi, Adriana Ceci, Thomas G. de Leeuw, Saskia N. de Wildt, Mariagrazia Felisi, Florentia Kaguelidou, Enora Le Roux, Rebecca Lundin, Laura Mangiarini, Dick Tibboel   +15 more
wiley   +1 more source

Food Not Bombs : The 1995 Food Not Bombs world gathering - San Francisco

, 1995
One of a series of posters painted by Food Not Bombs co-founder Keith McHenry to illustrate Food Not Bombs gatherings, tours or other actions. This poster depicts the Golden Gate Bridge in the background, a wizard, a radio station for "87.9FM", and ...
McHenry, Keith, 1957-
core   +1 more source

Food Not Bombs Menu drawing

One of a series of posters painted by Food Not Bombs co-founder Keith McHenry to illustrate Food Not Bombs gatherings, tours or other actions. This poster depicts a banner saying "Food Not Bombs Menu" in block letters with drawings of food on either side
McHenry, Keith, 1957-
core   +1 more source

Listening to Hong Kong children's perspectives through pretend play

British Educational Research Journal, EarlyView.
Abstract Quality in early childhood education and care (ECEC) has become an increasing concern in recent years. The issue has been regularly discussed by different stakeholders. However, the rising concern regarding quality in ECEC has not seriously taken into account children's perspectives.
Suzannie K. Y. Leung
wiley   +1 more source