How a health-based exposure limit supports scientifically justified cleaning acceptance criteria and cross-contamination control.
How a health-based exposure limit supports scientifically justified cleaning acceptance criteria and cross-contamination control.

O draft do ICH Q3E está em consulta pública. Entenda a estrutura da norma, os limiares TTC, QT e AET e o que muda na avaliação de extraíveis e lixiviáveis.
Technical guide to selecting critical effects and points of departure in PDE/HBEL assessments using clinical and non-clinical evidence.