Optimizing Extraction Recovery for Volumetric Adsorptive Microsampling (VAMS)
Compared to in-clinic sample collection, in-home sampling has many advantages. It saves time for patients, especially those who may be prohibitively far from a clinic...
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Journey of Biomarker from Discovery to Qualification
Noninvasive monitoring of nephrotoxicity is challenging. Kidney toxicity is currently monitored by plasma/serum markers, e.g., blood urea nitrogen, and serum...
Development and Regulatory approval for Toxicogenomics (TGX) biomarker to detect DNA damage-inducing agents
Gene expression biomarkers are now available for application in the identification of genotoxic hazards. The TGx-DDI transcriptomic biomarker can accurately...
Covid-19 Safety Testing Approaches
Rafiq Islam, Executive Director of Bioanalysis describes the approach that Celerion has taken to ensure the safety of our employees and patients via a suite of viral...
Mitigation Strategies for US and EU Supply Chain Risk Introduced by the COVID-19 Pandemic
The current global health crisis has a profound effect on the pharmaceutical supply chain, from raw materials, to clinical supply, to store shelves. This 30-minute...
Is Your Lab Cloud Ready
Originally driven by IT needs, cloud technology adoption is now being led by far reaching business demands.
Computational Studies of SARS-CoV-2 Application of Computational Chemistry and A.I.
The rapid outbreak of the novel severe acute respiratory syndrome 2 (SARS-CoV-2) has reached pandemic level and poses a serious global public health concern. Since the...
What We Need to Learn from Failures in COVID-19 Testing
The COVID-19 pandemic has not only disrupted our lives on all fronts, but it has also exposed our need to focus on the highest quality and safety in testing. With...
The Contribution of SIFT-MS to Breath Analysis and Drug Research
As a direct mass spectrometry, Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) is a novel tool to breath analysis and early-stage drug research. With SIFT-MS, the...
Functional Comparison of Human and Mouse OAT1 in Transport Characteristics and the Inhibitory Potential of Selected Drugs and Pesticides
In vivo data generated from rodents or other species are a very helpful tool to understand and to verify latent drug-drug interactions. However, extrapolation of...
Routine Accurate Mass Detection for Forced Degradation Studies
The best way to avoid costly surprises down the road during drug manufacturing is to apply the right methodologies from the beginning, to accurately identify and...
Intranasal Drug Delivery
This presentation will focus on advantage of nasal powder formulations and non-human primate (NHP) model to quantify nose to brain delivery of a model compound. This...
COVID-19 Three Strategies to Keep Your Program in Motion
During these unprecedented times, it's important to keep your drug development program moving toward approval.
Statistical Methods for CMC Comparability Studies
The FDA comparability guidance (1996) recognized the need for manufacturers to improve manufacturing processes and analytical methods without performing additional...
Right First Time for Tablet Disintegration and Dissolution Interplay between Formulation and Dosage Form Microstructure
One of the main performance criteria of a solid oral dosage form is that it is intended to possess a specific dissolution profile. In common industrial practice, the...