Webinars / Podcasts
As we enter the second quarter of 2020, a major SEND milestone has been reached with the requirement of SEND v3.1 for both IND and BLA/NDA study submissions. See how this impacts your submission and the increased scope of the standard within this update.
A comprehensive overview of early phase CNS drug development that will help you navigate the regulatory requirements for successful submission. Presented by Dr. BeatriceSetnik, PhD, Chief Scientific Officer at Altasciences.
Bioanalytical Project Management — a Critical Function Adapted to the Study Type(s) of Your Drug Development Program
The objective of quantitative bioanalysis is to provide precise and accurate sample analysis results within the acceptable tolerance (variability) and study scope, so that sponsors can makego/no-go decisions.
Central Nervous System (CNS) drug evaluation requires the assessment of specific safety endpoints, such as the drug’s potential to cause impairing effects on driving, the likelihood that it may be abused or misused, or the risk of causing withdrawal symptoms if abruptly discontinued.