Results 111 to 120 of about 89,307 (230)

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

Mood in the moment: a study protocol for embedding ecological momentary assessments into established longitudinal cohorts to examine depression in real time. [PDF]

BMJ Open
Kwong ASF, Moody S, Taylor A, Lockhart C, Ogden R, Leal R, Mcmillan A, Harvey J, Brierley E, Matthews S, Hobbs R, Simmons A, Eley TC, Jacobson NC, Murray AL.   +14 more
europepmc   +1 more source

Environmental impact of antidepressants: Is a new prescription framework possible?

British Journal of Clinical Pharmacology, EarlyView.
Aims Antidepressants such as venlafaxine and sertraline pose high risks to water ecosystems. As depressive disorders and other mental health conditions become increasingly prevalent worldwide, prescription and environmental presence of these pharmaceuticals continue to rise. This study explores the practical viability of a new framework for prescribing
Matilde Bianconi, Valentina Giunchi, Michael Thiede, Elisa Sangiorgi, Marco Menchetti, Elisabetta Poluzzi   +5 more
wiley   +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

Ethylmalonic and Methylsuccinic Acids Disrupt Bioenergetics and Induce Mitochondrial Permeability Transition Through Thiol Redox Modulation in Rat Striatum: Potential Mechanisms Involved in Ethylmalonic Encephalopathy. [PDF]

Neurochem Res
Marcuzzo MB, Zemniaçak ÂB, da Rosa JS, Verdi BSS, Benati MPDV, de Andrade Silveira J, do Nascimento JG, de Almeida Moreira H, Dias-Oliveira M, Souza DO, Amaral AU, Zanatta G, Wajner M, Leipnitz G.   +13 more
europepmc   +1 more source

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

Promoting Psychological Resilience and Well-Being in Youth With a Smartphone-Based Ecological Momentary mHealth Intervention: Secondary Analysis of a Microrandomized Trial. [PDF]

J Med Internet Res
Wierzba E, Schick A, Rauschenberg C, Fechtelpeter J, Hiller S, Götzl C, Durstewitz D, Krumm S, Koppe G, Reininghaus U.   +9 more
europepmc   +1 more source

Pharmacokinetic Assessment of Atazanavir and Favipiravir Following Echinacea Supplementation: A Controlled Herb–Drug Interaction Investigation

Biopharmaceutics &Drug Disposition, EarlyView.
Pharmacokinetic interactions between Echinacea and two antiviral drugs, favipiravir and atazanavir, were assessed in rats. The findings suggest that Echinacea does not significantly affect the pharmacokinetics of favipiravir and atazanavir. These results provide preliminary evidence that concurrent use of Echinacea with these antiviral drugs may be ...
Siva Nageswara Rao Gajula, Jeevan Sai Kallam, Aarika Kanukolanu, Ganesh Korada, Lakshmi Vineela Nalla   +4 more
wiley   +1 more source

Real-Time Stress Experiences and Physiological and Psychological Responses Among LGBTQ+ Young Adults: Findings from the Stress and Heart Pilot Study. [PDF]

Sensors (Basel)
Jun HJ, Lee KH, Urueta Tapia D, Calzo JP, Corliss HL.   +4 more
europepmc   +1 more source