Results 221 to 230 of about 3,658,897 (299)

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

Spatial distribution and associated factors of non-uptake of DTP3 vaccination among children aged 12-23 months in East Africa: geospatial analysis. [PDF]

BMC Public Health
Beshah BY, Abebe AW, Eticha BL, Desalegn HK, Bedada TD.   +4 more
europepmc   +1 more source

Operationalization of the African Medicines Agency: Retrospective evaluation of the continental centralized pilot procedure timelines to recommendation and national registrations

British Journal of Clinical Pharmacology, EarlyView.
Aims Regulatory inconsistency across Africa causes duplicative assessments, prolonged approvals, and delayed medical access. To inform the African Medicines Agency (AMA), the African Medicines Regulatory Harmonisation (AMRH) piloted Africa's first continental scientific evaluation of human medicinal products.
Alex Juma Ismail, Lerato Moeti, Delese Mimi Darko, Stuart Walker, Sam Salek   +4 more
wiley   +1 more source

Prevalence of person-centered maternity care during childbirth and its predictors among women who gave birth in health facilities of East Africa: A systematic review and meta-analysis. [PDF]

PLOS Glob Public Health
Alelign YA, Getnet C, Ayele A, Debela DE, Gomora D, Embiale A, Sintayehu Y, Ejigu N.   +7 more
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

Social-ecological transformations towards sustainability in drylands: A conceptual framework with examples from the Karamoja cluster in East Africa. [PDF]

Ambio
Bargués-Tobella A, Knutsson P, Bostedt G, Hörnell A, Lindvall K, Mpairwe D, Mureithi S, Nyberg G, Nyberg Y, Ong'ao Ng'asike P, Schumann B, Turinawe A, Vågen TG, Winowiecki LA, Wredle E, Öborn I.   +15 more
europepmc   +1 more source

Analysis of regulatory review models and approval timelines across selected African medicines regulatory authorities using the OpERA framework (2020–2024)

British Journal of Clinical Pharmacology, EarlyView.
Background The World Health Organization (WHO) developed the Global Benchmarking Tool (GBT) to assess national regulatory systems and support regulatory‐system strengthening across regulatory functions. Several African National Medicines Regulatory Authorities (NMRAs) have achieved Maturity Level 3 (ML3).
Constance Sakala Chisha, Stephanie Leigh, Makomani Siyanga, Grace Matimba, Richard Rukwata, Mercy Owusu‐Asante, Kwabena Frimpong‐Manso Opuni, Pratibha Sobrun, Boitumelo Semete‐Makokotlela, Adem Kermad, Stuart Walker   +10 more
wiley   +1 more source

Co-creation as a knowledge mobilization process in digital health regulation in East Africa: The making of the DigiReg compass. [PDF]

Health Res Policy Syst
Sekalala S, Lake SJ, Mbaka P, Nyotu R, Muhoza E, Samow A, Mbate F.   +6 more
europepmc   +1 more source

A scoping review of adverse events associated with concomitant beta‐adrenoreceptor blockers and selective serotonin reuptake inhibitors

British Journal of Clinical Pharmacology, EarlyView.
Beta‐adrenoreceptor blockers (beta‐blockers) and selective serotonin reuptake inhibitors (SSRIs) are commonly used medications and often used together, such as for the treatment of anxiety. However, there is no recent review of any potential adverse events related to concomitant use of medicines from each group.
Ziyi Cai, James Sutton, Charlotte Archer, Caroline S. Copeland, Joseph Hayes, Charles E. Leonard, Nicky Lidbetter, Kenneth K. C. Man, Faraz Mughal, Ian C. K. Wong, Hayley C. Gorton   +10 more
wiley   +1 more source

The health and economic burden of podoconiosis in East Africa: A systematic review and meta-analysis of health outcomes with narrative synthesis of economic evidence. [PDF]

PLoS Negl Trop Dis
Hitimana N, Anagnostopoulou V, Bremner S, Uwimana NU, Hounsome N, Rugema L, Mutesa L, Semrau M.   +7 more
europepmc   +1 more source