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An effective processing pipeline for harmonizing DNA methylation data from Illumina’s 450K and EPIC platforms for epidemiological studies
ObjectiveIllumina BeadChip arrays are commonly used to generate DNA methylation data for large epidemiological studies. Updates in technology over...
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Analysis and comparative evaluation of expedited programs for gene therapy products: insights from the United States, the European Union, Japan, and South Korea
Gene therapy products (GTPs) used for incurable diseases can be expedited for early commercialization to fulfill unmet needs. This study analyzed the...
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Increasing Efficiency and Cost-Effectiveness by Automating the Authoring of the Development Safety Update Report
IntroductionA Development Safety Update Report (DSUR) is a comprehensive review of safety information collected during an annual reporting period for...
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PFASs–restriction proposal commentary on ECHA’s Annex XV restriction report, proposal for a restriction, March 2023
PFASs are defined as substances that contain at least one fully fluorinated methyl (CF 3 –) or methylene (–CF 2 –) carbon atom. The excellent technical...
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Important Considerations for ELISpot Validation
The ELISpot assay has a solid place in the immune monitoring field for over 40 years. It is an assay that can assess the function of single immune...
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Perspectives in Immunotherapy: meeting report from Immunotherapy Bridge (Naples, November 30th–December 1st, 2022)
The discovery and development of novel treatments that harness the patient’s immune system and prevent immune escape has dramatically improved...
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Meeting Report: N-Nitrosamine Impurity Control Strategies in the Pharmaceutical and Biotechnology Industries
The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Control (CMC) Community hosted a virtual panel discussion...
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AAPS Workshop Report on ICH M10
Over the last decade, several regulatory guidelines on bioanalytical method validation (BMV) have been issued by regulatory agencies around the...
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Re-evaluation of a microbiological acceptable daily intake for tylosin based on its impact on human intestinal microflora
As veterinary drugs available for fish is very restricted, there is growing trials for repurposing livestock drugs as aquatic animal drugs. Tylosin...
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In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report
The pharmaceutical industry and regulatory agencies rely on dissolution similarity testing to make critical product performance decisions as part of...
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Progress towards malaria elimination in the Greater Mekong Subregion: perspectives from the World Health Organization
Malaria remains a global health challenge, disproportionately affecting vulnerable communities. Despite substantial progress, the emergence of...
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A Static Headspace Gas Chromatography Method for Quantitation of Residual Solvents in Nanoformulations
Various organic solvents are widely used in the manufacturing, processing, and purification of drug substances, drug products, formulations,...
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Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations
This report summarizes podium presentations and breakout sessions from the second day of the 2019 M-CERSI workshop on In Vitro Dissolution Similarity...
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Consensus Recommendations for Clinical Outcome Assessments and Registry Development in Ataxias: Ataxia Global Initiative (AGI) Working Group Expert Guidance
To accelerate and facilitate clinical trials, the Ataxia Global Initiative (AGI) was established as a worldwide research platform for trial readiness...
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Defining the causes of sporadic Parkinson’s disease in the global Parkinson’s genetics program (GP2)
The Global Parkinson’s Genetics Program (GP2) will genotype over 150,000 participants from around the world, and integrate genetic and clinical data...
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Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop
The 2023 Generic Drug Science and Research Initiative Public Workshop organized by the U.S. Food and Drug Administration (FDA) discussed the research...
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Regulatory Aspects and Bottlenecks for Nutraceuticals
Nutraceuticals help in the prevention and therapy of many illnesses. The market of nutraceutical is expanding and there is an increase in the demand...
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A systematic methodology review of fluorescence-guided cancer surgery to inform the development of a core master protocol and outcome set
BackgroundFluorescence-guided precision cancer surgery may improve survival and minimize patient morbidity. Efficient development of promising...
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Laboratory and clinical practices in antinuclear antibody detection and related antigens: recommendations from a Spanish multicentre survey
Antinuclear antibodies (ANA) are the most widely used immunological test for the diagnosis of autoimmune diseases. Despite the recommendations of...
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Safety Pharmacology Evaluation of Biopharmaceuticals
Biotechnology-derived pharmaceuticals or biopharmaceuticals are molecules such as monoclonal antibodies, bispecific antibodies, soluble/decoy...