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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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Why radiopharmaceuticals are gaining ground in the fight against cancer

Drug Target Review

This clinical success reinforced their focus on radioligand therapy (RLT), which uses radioactive isotopes linked to molecules that specifically target cancer cells. At the heart of radiopharmaceutical therapy is the ability to cause precise DNA damage within cancer cells, disrupting their ability to grow and divide.

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Navigating the challenges and opportunities of AI in drug development and personalised medicine

Drug Target Review

Artificial Intelligence (AI) is poised to transform the field of target discovery in drug development, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds. Cavlan explains that “they are brilliant at developing and bringing new drugs to market.”

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The science of ageing and restoring healthspan

Drug Target Review

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. The epigenome drifts with age, leading to dysregulated gene expression.

Science 145
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Five Promising Treatment Areas in Early-Phase Drug Development in 2024

Alta Sciences

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

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FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What CMC Questions Did They Answer? (Part 2)

FDA Law Blog: Drug Discovery

For adeno-associated viral vectors, examples may include characterization of non vector DNA impurities in capsids by next-generation sequencing, vector genome size analysis, and detection of capsid amino acid modifications by mass spectrometry. It is important that sponsors do not miss an opportunity to engage with CBER on CMC topics.

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Evaluating Impurities in New Drugs to Prevent Delays in Development

The Premier Consulting Blog

(Degradants are impurities arising from the degradation of the drug substance or a reaction with an excipient and/or the immediate container.) Assessment and control of DNA reactive impurities Another important guidance document related to impurities and degradants in new small molecule drugs is ICH M7(R1).