Results 171 to 180 of about 6,400,193 (276)

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

Exploring new avenues: Psychedelic‐assisted therapy for young people

British Journal of Clinical Pharmacology, EarlyView.
Rates of mental illness in young people are increasing, whereas the development of novel mental health treatments has not significantly progressed. Psychedelic‐assisted therapy, using substances such as psilocybin and 3,4‐methylenedioxymethamphetamine (MDMA), has shown potential in the treatment of mental illnesses in the adult population, including ...
Ioanna Artemis Vamvakopoulou, Dasha Nicholls, David J. Nutt, Martina Di Simplicio   +3 more
wiley   +1 more source

Food Not Bombs : Food Not Bombs in Melbourne, Australia

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 city with a water way and farm in the background, some Australian animals, a woman with a
McHenry, Keith, 1957-
core   +1 more source

Food choices and beliefs in adults with inflammatory bowel disease in Sweden. [PDF]

BMC Gastroenterol
Andersson S, Korwel KM, Sjöberg K, Lesnovska KP, Whelan K, Hedin CR, Vulcan A.   +6 more
europepmc   +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

Healthy and Sustainable Food Choices in European Households: A Cross-Cultural Study of Knowledge, Practices, Intentions, and Barriers. [PDF]

Nutrients
Baranda AB, da Quinta N, Rioja P, Ríos Y, Meinilä JM, Bargiel-Matusiewicz K, Ziółkowska N, Heikkilä ME, Kramer M, Erkkola M, Santa Cruz E.   +10 more
europepmc   +1 more source

Mobile health interventions to improve adherence to oral anticoagulant treatment: A systematic review and critical analysis

British Journal of Clinical Pharmacology, EarlyView.
Aims Non‐adherence to oral anticoagulants (OACs) is associated with significant morbidity and mortality. Mobile health (mHealth) interventions have been used to improve medication adherence across the three phases of initiation, implementation and persistence.
Non Davies, Elin Haf Davies, Dyfrig A. Hughes   +2 more
wiley   +1 more source

Development and Validation of a Questionnaire to Assess Secondary Food Habits Associated With Smoking. [PDF]

Cureus
Prabhakar M, B K, Chaly PE, Sg RK, M A.
europepmc   +1 more source

Pharmacokinetics and safety of a modified‐release psilocybin formulation: A SAD Phase I trial in normal‐weight and overweight/obese participants

British Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to evaluate the safety, tolerability and pharmacokinetics of a novel oral modified‐release psilocybin formulation (REL‐P11) in normal‐weight and overweight/obese healthy adults and to assess its suitability for controlled, subperceptual exposure, in light of emerging evidence supporting serotonergic modulation in metabolic ...
Anna Signor, Stefano Comai, Gianfranco Pasut, Franco Folli, Marco Gentilucci, Negar Gharavi, Sofia Raitsin, Thuy Van Nguyen, Marco Pappagallo, Andrea Mattarei, Paolo L. Manfredi, Sara De Martin   +11 more
wiley   +1 more source

Food Not Bombs : The Food Not Bombs gathering - Tampa

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 city in the background, a farm, people playing music on a stage, and people holding a ...
McHenry, Keith, 1957-
core