The Regulatory Stance on Oligonucleotide Enantiomers
The panel dives into the regulatory stance on oligonucleotide enantiomers. The role of batch-to-batch reproducibility, new drug application (NDA) filing, and current guidelines are covered.
Regulatory guidelines must be considered when discussing oligonucleotide analysis and enantiomers. The panel reviews the current regulatory stance on this topic and common analytical bottlenecks relative to regulatory compliance.
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