Bioanalytical and Statistical Methods to Charachterize The Diastereomer Composition of Oligonucleotide Therapeutics for Advancing New and Generic Drug Development
Time: 1:05 pm
day: Pre-Conference Workshop Day
Details:
This workshop will discuss the analytical challenges associated with characterizing the diastereomer composition of oligonucleotide therapeutics and explore advancements in both analytical and statistical methods to overcome these limitations. The focus will be on the use of specific examples involving FDA-approved drugs and synthetic analogues to demonstrate the value of integrating analytical methods with validated statistics.
Highlights:
- Discuss the limitations and advantages of using multiple analytical methods to evaluate the diastereomer composition in oligonucleotide therapeutics
- Statistical evaluation of approved drug products to synthetic analogues for comparing diastereomer composition
- Discuss the role synthetic chemistry plays in biasing diastereomer composition
Speakers:
