Letters From Our Readers.
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ABSTRACT:
SUBMITTER: Ganzer N
PROVIDER: S-EPMC8382005 | biostudies-literature | 2017 May
REPOSITORIES: biostudies-literature
Publications
Letters From Our Readers.
Ganzer Niels N Feldmann Ingalill I Bondemark Lars L
The Angle orthodontist 20170501 3
Similar Datasets
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Project description:"Letters to the Editor" that address original articles significantly contribute to medical literature. Utilizing letters published in obstetrics and gynecology journals as a study model, I aimed to classify letters according to their context, providing a valuable framework for readers to comprehend the significance of letters and for authors to effectively write them. Using a sample of 40 recent letters from the Journal of Obstetrics and Gynaecology Research (JOGR), I classified letters into three main categories based on their attitude to addressed articles: Disagreement, Agreement, and Complementary. I further subclassified each category into subcategories, including "Interpretation claim," "Data addition," and "Historical viewpoint." The same procedure was carried out for the 24 most recent letters from BJOG and the American Journal of Obstetrics and Gynecology and also for the JMA Journal. Disagreement letters were prevalent in all three OBGYN journals, accounting for 1/2 to 2/3 of all letters. The rest letters were categorized either as "Agreement" or "Complimentary." Subcategorizations demonstrated different ratios of letters of the three categories among journals. I believe that the attempt to categorize and subcategorize letters offers valuable insights into the letters, potentially enhancing clarity in medical literature communication.
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Project description:Modulation of gene expression through epigenetic signaling has recently emerged as a novel approach in treating human disease. Specifically, chromatin reader proteins, which mediate protein-protein interactions via binding to modified lysine residues, are gaining traction as potential therapeutic targets. Herein, we review recent efforts to understand and modulate the activity of chromatin reader proteins with small-molecule ligands.
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Project description:PurposeTo launch a pharmaceutical product in the US market, approval from the FDA is required. Pharmaceutical companies undergo FDA pre-approval inspection (PAI for small molecule products) or pre-license approval (PLI for biological products) at their manufacturing sites (including contract development and manufacturing organization, testing laboratories, and packaging labelling facilities) prior to approval. After the products are approved by the FDA, surveillance inspections are performed by the FDA which are risk based as which company and which site will be inspected. The present study examines the causes of warning letters issued by the Center for Drug Evaluation and Research (CDER), FDA to the pharmaceutical companies after post-approval inspections.MethodsWarning letters issued from the time period 2010 to 2020 were obtained from the FDA website, and information about date of issuance, company, and type of violations was extracted for the study.ResultsPoor compliance to CGMP and misbranding were the most common reasons for the warning letters. Detailed analysis of CGMP warning letters elucidated three major types of violations, namely deficiencies in process validation, documentation practices (data integrity), and quality control corresponding to 26%, 21%, and 15% warning letters, respectively.ConclusionReview of the analysed letters demonstrates that the FDA's major concern is over CGMP compliance. To avoid these warning letters, pharmaceutical manufacturers need to improve their quality compliance and focus on creating effective quality management systems that govern the entire manufacturing process, quality control, employee training, and documentation practice. Companies should develop an internal compliance check list and also be ready for corrective measures as and when required.Supplementary informationThe online version contains supplementary material available at 10.1007/s12247-022-09678-2.
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Project description:Histone modifications not only play important roles in regulating chromatin structure and nuclear processes but also can be passed to daughter cells as epigenetic marks. Accumulating evidence suggests that the key function of histone modifications is to signal for recruitment or activity of downstream effectors. Here, we discuss the latest discovery of histone-modification readers and how the modification language is interpreted.
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