ICON’s Patient Centred Outcomes and the American Academy of Sleep Medicine have developed PLATO 11, a validated, patient centred PRO tool designed to better capture the lived experience of people with obstructive sleep a...
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Challenges of free payload concentration analysis in ADC studies
Analysing free payload concentration vital to assess the efficacy, toxicity and safety of ADC therapies but doing so requires sophisticated methods.
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Why assessing the pharmacokinetics of antibody-drug conjugates is so complex
In this article we look at some of the challenges of typical bioanalytical ADC assays and some recent developments in the area.
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Oligonucleotide progression into early phase studies
In this blog, we explore the importance of quality control testing for oligonucleotide formulations in early phase clinical trials. While not fully addressed by ICH Q3A/Q6A, these products must comply with parts of EU GMP Annex 1 and the draft EMA guideline to ensure regulatory readiness.
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CMC IMP considerations for oligonucleotides
There are numerous strategies being developed to enhance the delivery of oligonucleotides, potentially changing the formulation and mode of drug delivery. However for now, we have to manufacture a sterile injection formulation.
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Minimising impurity formation in oligonucleotide synthesis
In the first installment of our three-part series, we provide an introduction to oligonucleotide therapeutics and examine how API synthesis strategies impact impurity formation, highlighting best practices for risk mitigation.
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Clinical trial protocol design amid evolving global IVD regulations
Clinical trial protocol design considerations driven by the current global evolution in vitro diagnostic device regulations impacting clinical testing laboratories.
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New opportunities in immunogenicity
ICON experts explore opportunities in immunogenicity approaches, best practices for achieving high-quality ADA assays and emerging trends in this evolving field.
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Transforming CML patient monitoring with ICON’s innovative RNA-based NGS assay
ICON's new RNA-based NGS assay improves CML monitoring, offering higher sensitivity and specificity, including for the identification of typical and atypical BCR::ABL1 transcript types and the detection of TKI resistant mutation.
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Use of ddPCR and qPCR assays for PK and safety monitoring in Cell & Gene Therapy clinical trials
Immunotherapy technologies are rapidly advancing, as are the methods of ensuring their safety and reliability. ICON explores the tools used in CGT trials.
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Anatomic pathology in the digital age
The development of new, innovative digital technologies has provided the tools to rethink the way we design and conduct clinical trials. One area that has been particularly impacted by this digital age is anatomical pathology.
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Controlling logistics costs can significantly reduce trial lab expenses
ICON has developed a lab logistics program to reduce costs
