Evaluation of Therapeutic Equivalence for the Follow-On Version of Intravenously Administered Non-Biological Complex Drugs
Sign Up to like & getrecommendations! Published in 2020 at "Clinical Pharmacokinetics"
DOI: 10.1007/s40262-020-00889-9
Abstract: The interchangeability evaluation for generic drugs formulated as intravenous injections normally only requires assessments of pharmaceutical equivalence (PE) when the medicinal products are simple small-molecule drugs. However, intravenously administered non-biological complex drugs (NBCDs), such as… read more here.
Keywords: intravenously administered; non biological; drug; evaluation ... See more keywords
Addressing a future pandemic: how can non-biological complex drugs prepare us for antimicrobial resistance threats?
Sign Up to like & getrecommendations! Published in 2022 at "Materials horizons"
DOI: 10.1039/d2mh00254j
Abstract: Loss of effective antibiotics through antimicrobial resistance (AMR) is one of the greatest threats to human health. By 2050, the annual death rate resulting from AMR infections is predicted to have climbed from 1.27 million… read more here.
Keywords: addressing future; complex drugs; biological complex; resistance ... See more keywords
Perspectives on the use of non-biological pharmacotherapy for adult-onset Still’s disease
Sign Up to like & getrecommendations! Published in 2022 at "Expert Opinion on Pharmacotherapy"
DOI: 10.1080/14656566.2022.2126764
Abstract: ABSTRACT Introduction The treatment of the patients with adult-onset Still’s disease (AOSD) remains largely empirical and it is based on the administration of immunosuppressive drugs. In this work, we described the use of non-biological pharmacotherapies… read more here.
Keywords: pharmacotherapy; adult onset; use non; still disease ... See more keywords
Statistics or biology: the zero-inflation controversy about scRNA-seq data
Sign Up to like & getrecommendations! Published in 2022 at "Genome Biology"
DOI: 10.1101/2020.12.28.424633
Abstract: Researchers view vast zeros in single-cell RNA-seq data differently: some regard zeros as biological signals representing no or low gene expression, while others regard zeros as missing data to be corrected. To help address the… read more here.
Keywords: zeros; seq data; biological zeros; non biological ... See more keywords
Efficacy and safety of non-pharmacological and non-biological interventions: a systematic literature review informing the 2022 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis
Sign Up to like & getrecommendations! Published in 2022 at "Annals of the Rheumatic Diseases"
DOI: 10.1136/ard-2022-223297
Abstract: Objective To update the evidence of non-biological treatments for axial spondyloarthritis (axSpA), as a basis for the 2022 Assessment of SpondyloArthritis international Society-European Alliance of Associations for Rheumatology (ASAS-EULAR) recommendations for the management of axSpA.… read more here.
Keywords: pharmacological non; efficacy; non pharmacological; non biological ... See more keywords
Non-Biological and Biological Risk Indicators for Tooth Wear Outcomes in Adults
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DOI: 10.1159/000527091
Abstract: This study was undertaken to estimate the prevalence and severity of tooth wear (TW), as well as to assess non-biological and biological risk indicators for TW outcomes in adults. A cross-sectional study, adhering to the… read more here.
Keywords: biological biological; tooth wear; risk indicators; risk ... See more keywords
Non-Biological Slaughterhouse Wastewater Treatment with Membrane Processes—An Opportunity for Water Recycling
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DOI: 10.3390/nano12132314
Abstract: The pressure-driven membrane separation processes ultrafiltration (UF) and reverse osmosis (RO) enable the effective purification of wastewater, in particular in combination, allowing organic and inorganic contaminants to be separated from the wastewater. Consequently, this work… read more here.
Keywords: slaughterhouse wastewater; wastewater; water; non biological ... See more keywords
Regulatory considerations for generic products of non-biological complex drugs
Sign Up to like & getrecommendations! Published in 2023 at "Journal of Food and Drug Analysis"
DOI: 10.38212/2224-6614.3441
Abstract: The Non-Biological Complex Drug (NBCD) Working Group defines an NBCD as “a medicinal product, not being a biological medicine, where the active substance is not a homo-molecular structure, but consists of different (closely related and… read more here.
Keywords: generic products; considerations generic; regulatory considerations; follow versions ... See more keywords
Non-biological synthetic spike-in controls and the AMPtk software pipeline improve mycobiome data
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DOI: 10.7717/peerj.4925
Abstract: High-throughput amplicon sequencing (HTAS) of conserved DNA regions is a powerful technique to characterize microbial communities. Recently, spike-in mock communities have been used to measure accuracy of sequencing platforms and data analysis pipelines. To assess… read more here.
Keywords: amptk software; non biological; spike; spike controls ... See more keywords