English to Russian Medical Medical: Pharmaceuticals GMP, валидация

Additionally, development/PV Stage 1 studies to understand and reduce and/or monitor homogeneity of the drug substance lead to an understanding of assay CQA since these values can be calculated from the mean of the **individual tablet assay values**.
• At-line NIR **individual tablet assay** for UDU provides a high level of confidence (PAT tool) using stratified sampling
• Reduced frequency of at-line testing of **individual tablet assay** for UDU