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Neutralizing Antibody Sample Testing and Report Harmonization
Immunogenicity testing and characterization is an important part of understanding the immune response to administration of a protein therapeutic....
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Harmonization of Hemostasis Testing Across a Large Laboratory Network: An Example from Australia
Harmonization and standardization of laboratory tests and procedures carry a variety of benefits. For example, within a laboratory network,...
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Neutralizing Antibody Validation Testing and Reporting Harmonization
Evolving immunogenicity assay performance expectations and a lack of harmonized neutralizing antibody validation testing and reporting tools have...
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Anti-drug Antibody Sample Testing and Reporting Harmonization
A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of...
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Anti-drug Antibody Validation Testing and Reporting Harmonization
Evolving immunogenicity assay performance expectations and a lack of harmonized anti-drug antibody validation testing and reporting tools have...
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Dissolution Profile Similarity Assessment—Best Practices, Decision Trees and Global Harmonization
During the write-up of the meeting summary reports from the 2019 dissolution similarity workshop held at the University of Maryland’s Center of...
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Harmonization of summaries of product characteristics (SmPCs) of drugs with the same active ingredients: an evaluation of SmPCs of the most frequently prescribed active substances
PurposeIn aut-idem or generic substitution, discrepancies between summaries of product characteristics (SmPCs) referring to the same active substance...
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Report on the 4th Board Meeting of the International Human Phenome Consortium
Phenome has become a consensus as the next innovation source of biomedicine. As the global network dedicated to large-scale research efforts on human...
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Consistency of parent-report SLC6A1 data in Simons Searchlight with Provider-Based Publications
BackgroundSLC6A1 -related disorder is a recently identified, rare, genetic neurodevelopmental disorder that is associated with loss-of-function...
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Breastfeeding and risk of childhood brain tumors: a report from the Childhood Cancer and Leukemia International Consortium
PurposeStudies report mixed findings regarding the association of breastfeeding with childhood brain tumors (CBT), the leading causes of...
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Coordinating Global Multi-Site Studies of Military-Relevant Traumatic Brain Injury: Opportunities, Challenges, and Harmonization Guidelines
Traumatic brain injury (TBI) is common among military personnel and the civilian population and is often followed by a heterogeneous array of...
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Systemic inflammatory effects of zinc oxide particles: is a re-evaluation of exposure limits needed?
Exposure to airborne substances such as gases, vapours, and particles remains a relevant health risk in many workplaces. A current topic and cause...
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Drug Dissolution in Oral Drug Absorption: Workshop Report
The in-person workshop “Drug Dissolution in Oral Drug Absorption” was held on May 23–24, 2023, in Baltimore, MD, USA. The workshop was organized into...
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Towards harmonization of microscopy methods for malaria clinical research studies
Microscopy performed on stained films of peripheral blood for detection, identification and quantification of malaria parasites is an essential...
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Severe malaria intervention status in Nigeria: workshop meeting report
Nigeria accounts for 39% of global malaria deaths in children under 5 years of age and the effective management of severe malaria is a health...
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How to report the antinuclear antibodies (anti-cell antibodies) test on HEp-2 cells: guidelines from the ICAP initiative
Results of the anti-nuclear antibodies-indirect immunofluorescence assay (anti-cell antibodies test) on HEp-2 cell substrates should be communicated...
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Educational interventions in pharmacovigilance to improve the knowledge, attitude and the report of adverse drug reactions in healthcare professionals: Systematic Review and Meta-analysis
ObjectivesUnderreporting of adverse drug reactions (ADRs) limits and delays the detection of signs. The aim of this systematic review with...
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Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid
The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Controls (CMC) Community hosted two virtual panel...