The ICH Q1E guidance sets forth a fixed linear model approach for describing the stability profile of an active compound to set shelf life. The example given establishes shelf life based on potency loss over time. This type of model has commonly been applied to other quality attributes. This approach has proven quite useful for small molecule compounds, where kinetic considerations as a consequence of oxidation or hydrolysis are reasonable approximations to the loss in potency over time. Biologics are complex molecules with much larger molecular weight in general. Degradation mechanisms can be more complex involving deamidation or desialylation. Physical changes can include aggregation and changes in 3-dimensional structure which further can interfere with kinetic assumptions underlying a stability model. Consequently, curvature in the stability profile can result. At the same time, numerous quality attributes must be studied to demonstration preservation of molecular integrity for a large molecule. This raises the question of multiplicity. How to manage risk in this context when there may be several stability limiting attributes is also an important question where multivariate Bayesian approaches may be appropriate. This talk will give a high level overview of these questions with the objective of stimulating useful discussions amongst the panel members and audience in the context of both standard registration studies as well as forced degradation (accelerated) studies.