The quality and safety of a biopharmaceutical is determined by how well its manufacture is controlled. The challenge is that the modeling methods used to develop control strategies sometimes struggle ...

This article develops an estimating function-based approach to component estimation in the two-stage generalized linear model with univariate random effects and a vector of fixed effects. The novelty ...

In the UK, there was a case where TGN1412, an immunotherapy under development, triggered a cytokine storm within hours of ...