Po Cao, Ying-Wei Jin, Yin-Yin Duan, Jie Wang, Zhi-Hao Ping, Shi-Yuan Zhao, Jia-Yi Du, Su-Mei He, Hai-Bo Zhang, Dong-Dong Wang
For the tested simplified single device, cooling followed an exponential pattern, reached body-temperature level within about 7-8 min, and approached room temperature within about 16-20 min. The 30-min rule provides an adequate margin for this bounded scenario, but the findings should not be generalized to complex instruments, packages, multiple loads, or variable airflow conditions without further validation.
OBJECTIVE: Due to the therapeutic window of tacrolimus is narrow and there are significant individual differences in metabolism, a uniform dosage is prone to result in poor efficacy or increased toxic side effects. This study aimed to explore tacrolimus initial dosage optimization in membranous nephropathy (MN) patients based on model-informed precision dosing (MIPD).
METHODS: Population pharmacokinetic model, an effective tool of MIPD, was constructed using the non-linear mixed effect modeling approach implemented in NONMEM software, which encompassed a range of patient-related data, including demographic characteristics, physiological and biochemical test results, as well as details regarding concurrent medications.
RESULTS: From the aspect of individualized drug administration, in adult MN patients, the initial dosages of tacrolimus were 0.06 mg/kg, 0.04 mg/kg for patients weighted 50-53 kg, 53-100 kg, respectively. In pediatric MN patients, the initial dosages of tacrolimus were 0.12 mg/kg, 0.10 mg/kg, 0.08 mg/kg, 0.06 mg/kg for patients weighted 10-12.7 kg, 12.7-16.4 kg, 16.4-26.7 kg, 26.7-40 kg, respectively.
CONCLUSION: This study was the first time to simultaneously recommend the optimal initial dosage of tacrolimus for both adult and pediatric MN patients based on MIPD. Moreover, the dosage required for pediatric MN patients was higher than that for adult MN patients.