Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities.

Purpose: This study aimed to assess the current regulatory review process of the Zambia Medicines Regulatory Authority (ZAMRA) by identifying the key milestones and target timelines achieved for products approved from 2020 to 2023, as well as good review and quality decision-making practices implemented in the review process.

Methods: A standardised, validated questionnaire; Optimising Efficiencies in Regulatory Agencies (OpERA) and the OpERA Data Collection Template were completed by the author.

Results: Three review models are used by ZAMRA to review new active substances (NASs) and generic products: verification, for products prequalified by the World Health Organization or approved by a stringent regulatory authority (SRA); abridged, for well-established molecules or SRA-approved products; or full, for products not otherwise prequalified.

A history of studies of reproductive isolation between and .

and are a sister species pair that have been used as a model for studies of reproductive isolation and speciation for almost 100 years owing to their close evolutionary history, well characterized genetic differences, and overlapping geographic distribution. There are extensive analyses of both pre- and post-zygotic isolation, including studies of courtship divergence, conspecific sperm precedence (CSP) and how reinforcement by natural selection may or may not act to strengthen isolation in sympatry. Post-zygotic analyses explore the underlying mechanics of reproductive isolation; how inversions may give rise to initial speciation events and misexpression of key genes typically found within inversion regions render hybrid offspring unfit or inviable.

Neuroimaging markers of cognitive fatigue in individuals with post-acute sequelae of SARS-CoV-2 infection.

Persistent cognitive fatigue (CF) is the most reported symptom in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), but little is known about its underlying neural basis. This pilot study examined fMRI brain activation patterns during a fatiguing task in those with and without PASC. We hypothesized that individuals with PASC would show changes in CF-related brain activation within fatigue network.

Effects of the in ovo injection of an Escherichia coli vaccine on the hatchability and subsequent early post hatch characteristics of commercial layer chicks.

In the commercial table egg industry, avian pathogenic E. coli (APEC) can lead to significant economic loss and bird mortality. The Poulvac E.

The ClinGen Syndromic Disorders Gene Curation Expert Panel: Assessing the Clinical Validity of 111 Gene-Disease Relationships.

Purpose: The Clinical Genome Resource (ClinGen) Gene Curation Expert Panels (GCEPs) have historically focused on specific organ systems or phenotypes; thus, the ClinGen Syndromic Disorders GCEP (SD-GCEP) was formed to address an unmet need.

Methods: The SD-GCEP applied ClinGen's framework to evaluate the clinical validity of genes associated with rare syndromic disorders. 111 Gene-Disease Relationships (GDRs) associated with 100 genes spanning the clinical spectrum of syndromic disorders were curated.