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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

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FDA’s Project Optimus: A new era in oncology drug dosing

Drug Target Review

This approach aims to improve treatment efficacy (compared to cytotoxic chemotherapy), minimise toxicity, and necessitates an evolution in clinical trial methodologies. Genetic factors Mutations or alterations in tumour DNA (eg, EGFR mutations in lung cancer or HER2 amplification in breast cancer) are key targets of precision medicine.