Bioanalytics – Biomolecular
2019 PharmSci 360
Antisense oligonucleotides (ASO) are new and emerging class of therapeutics that have significant potential to address diseases that historically have been challenging to treat with small molecule drugs or biologics. The early Bioanalytical and PK/PD support for ASOs entail different considerations that is currently not fully appreciated and known to the wider pharmaceutical community. This talk will focus on the factors to be considered for early Bioanalytical and PK/PD support for ASO drug development. It will discuss the details of necessary LC-MS and Hybridization-based immunoassays, selection of bioanalytical assays and PK/PD evaluations and modeling of unique targets/therapeutic areas from an early development perspective.