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7 results for “Pharmaceutical manufacturing”
Extensive Checklist to cGMP Inspections in Pharmaceutical Manufacturing Plants
<p><span>cGMP inspections are an essential part of ensuring that pharmaceutical companies produce high-quality, safe, and effective drugs. These inspections help maintain the integrity of the pharmaceutical supply chain and protect public health. Pharmaceutical companies must prioritize continuous cGMP compliance, prepare thoroughly for inspections, and respond promptly to any observations made by inspectors to remain in good standing with regulatory authorities.</span></p> <p><span>Here's a comprehensive cGMP inspection checklist for a pharmaceutical company, incorporating requirements from USFDA, EMA, WHO, UKMHRA, TGA, and ANVISA. This checklist includes a rating system to evaluate compliance with each requirement.</span></p>
Evaluating the potential of Digital Twin technology on pharmaceutical manufacturing efficiency in Ireland: An in-depth analysis of Machinery Validation
<p>The dissertation titled <strong>"Evaluating the Potential of Digital Twin Technology on Pharmaceutical Manufacturing Efficiency in Ireland: An In-depth Analysis of Machinery Validation"</strong> explores the transformative impact of Digital Twin (DT) technology within Ireland's pharmaceutical manufacturing sector. Conducted by MSc candidate Gayathri Gopakumar at Griffith College Dublin, the research focuses on how DT technology can enhance machinery validation processes, thereby improving operational efficiency and ensuring regulatory compliance.</p> <p>Employing a qualitative research methodology, the study includes semi-structured interviews with industry experts to gather insights into the current awareness, perceived benefits, and challenges associated with DT adoption in the pharmaceutical industry. The research aims to provide a comprehensive understanding of DT technology's role in machinery validation and its broader implications for manufacturing efficiency.</p> <p>This work contributes to the existing body of knowledge by offering a detailed analysis of DT technology's potential applications in pharmaceutical manufacturing, with a specific focus on the Irish context. It serves as a valuable resource for professionals and researchers interested in the integration of advanced digital technologies in the pharmaceutical sector.</p>
Optimizing the selection of drug-polymer-water formulations for spray-dried solid dispersions in pharmaceutical manufacturing
<p>The files contain 2 MINLP formulations and supplementary material discussed in this publication. The MINLP problems are implemented and solved in GAMS version 36.2.0, using SBB and SCIP, a local and global MINLP solver, respectively.</p>
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
ClinicalTrials.gov study NCT02564497. IPD Sharing: Not stated. Countries: 1. Publications: 0.
A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation
ClinicalTrials.gov study NCT01331993. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects Un
ClinicalTrials.gov study NCT00940238. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects in
ClinicalTrials.gov study NCT00939835. IPD Sharing: Not stated. Countries: 1. Publications: 0.
ScienceDex guides
Understand access before you commit
These curated guides explain access requirements, typical timelines, costs, and reuse considerations for widely used research datasets.
Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.