CMIC：2011年GCC关于生物分析方法稳定性对联合给药和联合配方药物影响的建议白皮书（英文版）

In 2010, the global bioanalytical community learned of regulatory agency concern of the potential for co-administered compounds present in a bioanalytical matrix to impact the stability of analytes subject to bioanalytical measurement. This pertained to conducting frozen and freeze-thaw stability experiments with spiked matrix samples (stability QCs) that contained only the analytes of bioanalytical interest and not all of the dosed drug compounds. Following several FDA inspections, laborator