Transcription of CMC Regulatory Considerations for …
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CMC Regulatory Considerations for …
CMC Regulatory Considerations for Oligonucleotide Drug Products: FDA Perspective Mohan Sapru, , CMC Lead for Cardiovascular and Renal Products Office of New Drug Products Member, Emerging Technology Team (ETT). Office of Pharmaceutical Quality, CDER, FDA. OVERVIEW. Oligonucleotide-Based Therapeutics: Promises and Challenges Synthetic Oligonucleotides: Structural Aspects - Antisense Oligonucleotides - Double-Stranded Small Interfering RNAs (siRNAs). - Chemical Modifications of Oligonucleotides - Oligonucleotide Structure-Related Safety Considerations Synthetic Oligonucleotides: Major Regulatory Aspects - Regulatory Challenges - General CMC Considerations - Oligonucleotide-Specific CMC Considerations 2. Therapeutic Oligonucleotides - Exert effects through suppression of, or interference with mRNA.
3 Therapeutic Oligonucleotides - Exert effects through suppression of, or interference with mRNA translation, immune stimulation, protein binding, or through
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