Results 171 to 180 of about 4,990,327 (257)

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

open access: yesBritish 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   +4 more
wiley   +1 more source

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

open access: yesBritish 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   +10 more
wiley   +1 more source

The global extent of polypharmacy in neonatal intensive care: A systematic review

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Pharmaceutical treatment in the neonatal intensive care unit (NICU) is challenging, with neonates often receiving multiple drugs during hospitalization. Given their physiological immaturity, polypharmacy raises concerns about potential adverse effects, drug–drug interactions and the risk of supratherapeutic or subtherapeutic treatment.
Mia Finserås Bretun   +6 more
wiley   +1 more source

Caribbean Islands facilitated the colonization of Western Hemisphere barn owls, yet experienced rampant extinction. [PDF]

open access: yesProc Biol Sci
Zhao M   +6 more
europepmc   +1 more source

Inappropriate prescribing of gastric acid suppressants: A systematic literature review and meta‐analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Inappropriate prescribing of gastric acid suppressants (GASs) may compromise treatment outcomes. This study aimed to examine the prevalence of inappropriate prescribing of GASs in all healthcare settings. Methods This PROSPERO‐registered systematic literature review used PubMed and Embase databases to identify original English‐language studies ...
Dhani Wijaya   +5 more
wiley   +1 more source

Massive release of predominantly magmatic carbon drove an Early Jurassic hyperthermal. [PDF]

open access: yesNat Commun
Chen W   +7 more
europepmc   +1 more source

Adapting the WHO Global Competency Framework for Regulators of Medicines: Implementation lessons from the South African Health Products Regulatory Authority

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Medicines regulatory authorities require skilled staff to ensure timely, consistent and high‐quality regulatory decision making. The World Health Organization Global Competency Framework (WHO‐GCF) for Regulators of Medicines provides a common reference for defining regulatory workforce competencies while allowing adaptation to local needs.
Goonaseelan Pillai   +9 more
wiley   +1 more source

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