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1,055 results for “FDA”
Evolution of FDA Guidelines on Control of Nitrosamine Impurities in Human Drugs – A Comparative Analysis of September 2024 Revisions
<p>Nitrosamine impurities have become a significant concern in the pharmaceutical industry due to their carcinogenic potential. In response, the U.S. Food and Drug Administration (FDA) has continuously updated its guidelines to ensure the safety and efficacy of drug products. This review article provides a comprehensive analysis of the evolution of FDA guidelines on the control of nitrosamine impurities, with a particular focus on the September 2024 revisions. By comparing the latest guidance with previous versions, this article highlights key changes, including the expanded focus on Nitrosamine Drug Substance-Related Impurities (NDSRIs), updated risk assessment strategies, and the introduction of new Acceptable Intake (AI) limits. The analysis underscores the FDA's commitment to enhancing drug safety through rigorous control measures and global harmonization efforts.</p>
A Comprehensive Review of ANDA Submissions and Amendments Under GDUFA: FDA Guidelines for the Generic Drug Industry
<p><span>This review provides an in-depth analysis of the Food and Drug Administration's (FDA) guidance document titled <em>ANDA Submissions — Amendments to Abbreviated New Drug Applications (ANDAs) Under the Generic Drug User Fee Amendments (GDUFA)</em>, released in September 2024. The document serves as a comprehensive guide for the pharmaceutical industry, detailing the FDA's expectations regarding the classification, submission, and assessment of amendments to ANDAs and Prior Approval Supplements (PASs). The review discusses key elements of the guidance, including amendment categories (major, minor, and unsolicited), assessment timelines, the process for reclassification of amendments, and potential deficiencies in submissions. The guidance also addresses changes in classifications and assessment goals, deferred amendments, and best practices for ensuring timely FDA approval. This review aims to clarify the FDA’s current thinking on ANDA submissions under GDUFA and the practical implications for generic drug manufacturers seeking to comply with the established regulations.</span></p>
TOP-100 DOCKING POSES OF FDA APPROVED DRUGS AND DRUGS IN CLINICAL INVESTIGATION AT SARS-CoV2 MAIN PROTEASE
<p>7922 compounds were downloaded from NPC database (https://tripod.nih.gov/npc/). In order<br> to eliminate the non-specific binders, some criteria including molecular weight, between 100 to<br> 1000 g/mol; number of rotatable bonds, <100; number of atoms, between 10 and 100; number<br> of aliphatic and aromatic rings, <10; number of hydrogen-bond acceptor and donors, <10 were<br> set and as a result the total number of compounds was decreased to 6654. These ligands were<br> prepared using LigPrep module of Maestro at neutral pH (LigPrep, Schrodinger v.2017). In<br> molecular docking, we used following protein structure: SARS-CoV2 Main Protease, (PDB, 6LU7). The protein<br> was prepared using Protein Preparation module of Maestro. PROPKA was used for<br> determination of protonation states of amino acid residues. Restrained minimization was<br> performed with OPLS3 force field for the protein using 0.3 Å heavy atom convergence.<br> Docking was performed with Glide/SP using default settings. Top-100 docking poses were provided.</p>
TOP-100 DOCKING POSES OF FDA APPROVED AND DRUGS IN CLINICAL INVESTIGATION AT SARS-CoV2 SPIKE/ACE2 INTERFACE
<p>7922 compounds were downloaded from NPC database (https://tripod.nih.gov/npc/). In order<br> to eliminate the non-specific binders, some criteria including molecular weight, between 100 to<br> 1000 g/mol; number of rotatable bonds, <100; number of atoms, between 10 and 100; number<br> of aliphatic and aromatic rings, <10; number of hydrogen-bond acceptor and donors, <10 were<br> set and as a result the total number of compounds was decreased to 6654. These ligands were<br> prepared using LigPrep module of Maestro at neutral pH (LigPrep, Schrodinger v.2017). In<br> molecular docking, we used following protein structure: Spike Protein/ACE-2, (PDB, 6M0J). The protein<br> was prepared using Protein Preparation module of Maestro. PROPKA was used for<br> determination of protonation states of amino acid residues. Restrained minimization was<br> performed with OPLS3 force field for the protein using 0.3 Å heavy atom convergence.<br> Docking was performed with Glide/SP using default settings. Top-100 docking poses were provided.</p>
Dataset for identification of peptidomimetics and FDA approved drugs binding to novel allosteric pocket of the IRE1 RNase domain.
<p>Input files, protein-peptide and ligand docking datasets, and simulation trajectories, compressed in "rar" format. All calculations performed using the Schrödinger 2020-2 / 2020-3 software (modules Glide, Phase, Desmond). </p> <p>SI includes folders:</p> <p>1- "Peptide" folder contains the best peptide "Docking" complexes and "Pharmacophore" models </p> <p>2-"Quercitrin" folder contains the molecular "Docking", "MMGBSA" calculations, and "MD" simulation</p> <p>3-"Pemetrexed" folder contains the molecular "Docking", "MMGBSA" calculations, and "MD" simulation</p> <p> </p>
fda-motor-acoustic
<p>Repository of source files needed for experiments in the paper "Functional Logistic Regression for Motor Fault Classification Using Acoustic Data in Frequency Domain", submitted to Energies.</p> <p> </p> <div> <div> <div>The data set was created in the project NCN OPUS "Process Fault Prediction and Detection" (UMO-2021/41/B/ST7/03851)<br><br> <div> </div> <div></div> </div> </div> </div> <div> <div> </div> </div>
UPLC-MS/MS Method for quantitation of the recently FDA approved combination of vaborbactam and meropenem in human plasma
A parenteral medical combination containing vaborbactam (VBR) and meropenem (MRP) is used mainly to treat complicated urinary tract infections. A novel ultra-performance liquid chromatography (UPLC)- tandem mass spectrometric (MS/MS) method was developed for the sensitive determination of both compounds in human plasma. Sample preparation was performed by precipitation technique. The chromatographic separation was accomplished using the Acquity C18-BEH column, 0.01 M ammonium formate: acetonitrile (47:53, v/v) as a mobile phase with a flow rate of 0.2 mL/min. Analytes were monitored by applying multiple reaction monitoring (MRM). The bioanalytical validation criteria were conducted following the FDA recommendations. The method was linear within range 0.5 to 50 µg/mL, for both drugs. The intra-day and inter-day precision, as coefficient variation (%CV) and the accuracy, as % bias not exceed than 15% for both drugs. The percentage recovery of targeted analytes was not less than 77 %, calculated at three QC levels. The proposed method showed a suitable LLOQ value of 0.5 µg/mL for both analytes, which is far lower than the expected Cmax, which permits the use of this method for pharmacokinetic studies. The proposed method proved to be useful for the evaluation of this combination in both human plasma and pharmaceutical formulation.
Structures of FDA-approved drugs and their active metabolites and data sets of experimental PD and PK properties
<p>Data sets are extracted from the 2024 release of the e-Drug3D Database (2118 FDA-approved drug structures)</p> <ol> <li><strong>e-Drug3D_2118.zip </strong>(contains e-Drug3D_2118.sdf)<strong> -</strong> <strong>Chemical Structures</strong> - The e-Drug3D collection in SDF format file - one 3D conformer; ionization of carboxylic acid, phosphate, phosphonate, phosphonoamide, amidinium and guanidinium groups. The datablock contains the ID, name (INN), CAS number and Status.</li> <li><strong>e-Drug3D_2118_PK.csv - </strong><strong>Pharmacokinetics</strong> - Column/field value is separated by a semicolon. It contains the e-Drug3D ID, INN (drug name), CAS number, year of approval, Status, is_or_has a metabolite, routes of administration, Volume of distribution (VD), Clearance (Cl), Plasma Protein Binding (PPB), Half-life (t1/2), Bioavailability (F), Cmax/Tmax, comment on solubility.</li> <li><strong>e-Drug3D_2118_PD.csv -</strong> <strong>Pharmacodynamics</strong> - Column/field value is separated by a semicolon. It contains the e-Drug3D ID, INN (drug name), CAS number, year of approval, Status, Primary target, ATC code(s), PDB codes and main list of drug targets.</li> <li><strong>e-Drug3D_2118_RD.csv -</strong> <strong>FDA Registration Data</strong> - Column/field value is separated by a semicolon. It contains the ID, name (INN), CAS number, First year of approval, Status, <a href="http://www.knapsackfamily.com/knapsack_core/top.php">KNApSAcK</a> or <a href="https://www.npatlas.org">NPAtlas</a> Id if natural product, all associated NDA numbers [FDA approval number, name of the label file in PDF format, company name, year of approval and commercial name of the drug] and the Indication/Therapeutic class information.</li> <li><strong>labels.tar.gz</strong> - The drug label files in PDF format (compressed directory). A label file is named with the NDA number. The NDA number is the approval number assigned by the FDA. A drug may possess several NDA numbers (see the above e-Drug3D-RD data set).</li> </ol>
Effect of impeller rotational phase on the FDA blood pump velocity fields
Open the record for dataset details and reuse information.
Fig. 1 Screening flow, testing 1600 FDA compounds against S in Assessment of FDA-approved drugs against StrongyloideS rAtti in vitro and in vivo to identify potentially active drugs against strongyloidiasis
Fig. 1 Screening flow, testing 1600 FDA compounds against S. ratti
Base de datos de Medicamentos Aprobados por la FDA (2002-2024)
<p><span>Los datos han sido recolectados del sitio web "Drugs.com", específicamente de la página "New Drugs" (</span><span><a href="https://www.drugs.com/newdrugs.html"><span>https://www.drugs.com/newdrugs.html</span></a></span><span>). Este sitio web es una fuente relevante y confiable de información sobre nuevos medicamentos aprobados por la Administración de Alimentos y Medicamentos (FDA) de los Estados Unidos y otras agencias reguladoras de medicamentos de todo el mundo.</span></p>
Combined high-depth Illumina+PacBio Sequencing of several samples from FDA-ARGOS
<p>The (real) sequencing data is compiled from a concatenation of sequencing runs from Database for Reference Grade Microbial Sequences (FDA-ARGOS). Specifically, the following samples were sequenced with both Illumina and PacBio. The sample accessions are shown below.</p> <pre><code> BioSample Run Platform Organism bases source <chr> <chr> <chr> <chr> <dbl> <chr> 1 SAMN06173354 SRR5409204 ILLUMINA Bacillus anthracis 1778000000 Colorado Serum Co., Anthrax Spore Vaccine 2 SAMN06173354 SRR5409205 PACBIO_SMRT Bacillus anthracis 2420000000 Colorado Serum Co., Anthrax Spore Vaccine 3 SAMN06173356 SRR5448657 ILLUMINA Bacillus circulans 2311000000 swab with brown-gray powder 4 SAMN06173356 SRR5448656 PACBIO_SMRT Bacillus circulans 242000000 swab with brown-gray powder 5 SAMN04875535 SRR4123920 ILLUMINA Elizabethkingia anophelis 1357000000 blood 6 SAMN04875535 SRR4123919 PACBIO_SMRT Elizabethkingia anophelis 2173000000 blood 7 SAMN06173306 SRR5413253 ILLUMINA Escherichia coli O157 3051000000 clinical isolate 8 SAMN06173306 SRR5413252 PACBIO_SMRT Escherichia coli O157 915000000 clinical isolate 9 SAMN06173318 SRR5413272 ILLUMINA Mycobacterium avium subsp. paratuberculosis 1032000000 feces 10 SAMN06173318 SRR5413271 PACBIO_SMRT Mycobacterium avium subsp. paratuberculosis 462000000 feces 11 SAMN07312468 SRR5879398 ILLUMINA Mycobacterium tuberculosis 1054000000 human 12 SAMN07312468 SRR5879396 PACBIO_SMRT Mycobacterium tuberculosis 1854000000 human 13 SAMN04875542 SRR4123931 ILLUMINA Neisseria gonorrhoeae 1053000000 ATCC strain 14 SAMN04875542 SRR4123930 PACBIO_SMRT Neisseria gonorrhoeae 1117000000 ATCC strain </code></pre> <p>Samples were selected with the SRA Run selector. The SraRunTable.txt file was exported containing the metadata for each sample, and fastq-dump from the SRA toolkit was used to write out fastq files for each run, with paired Illumina data being split into separate _1.fastq.gz and _2.fastq.gz files. </p>
[Trial of device that is not approved or cleared by the U.S. FDA]
ClinicalTrials.gov study NCT06698731. IPD Sharing: Not stated. Countries: 0. Publications: 0.
A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects
ClinicalTrials.gov study NCT00363142. IPD Sharing: Not stated. Countries: 2. Publications: 1.
Safety and Therapeutic Potential of the FDA-approved Drug Metformin for C9orf72 ALS/FTD
ClinicalTrials.gov study NCT04220021. IPD Sharing: NO. Countries: 1. Publications: 6.
[Trial of device that is not approved or cleared by the U.S. FDA]
ClinicalTrials.gov study NCT07140497. IPD Sharing: Not stated. Countries: 0. Publications: 0.
[Trial of device that is not approved or cleared by the U.S. FDA]
ClinicalTrials.gov study NCT07195292. IPD Sharing: Not stated. Countries: 0. Publications: 0.
[Trial of device that is not approved or cleared by the U.S. FDA]
ClinicalTrials.gov study NCT01630707. IPD Sharing: Not stated. Countries: 0. Publications: 0.
Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia
ClinicalTrials.gov study NCT01426230. IPD Sharing: Not stated. Countries: 1. Publications: 1.
A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy
ClinicalTrials.gov study NCT03404401. IPD Sharing: UNDECIDED. Countries: 1. Publications: 1.
ScienceDex guides
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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.