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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Assessment of Similarity in Antipsychotic Exposure-Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia
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Assessment of Similarity in Antipsychotic Exposure-Response Relationships in Clinical Trials Between Adults and Adolescents With Acute Exacerbation of Schizophrenia

机译：抗精神病药抗抗抗精神病暴露关系评估成人与青少年临床试验中的临床试验，精神分裂症急性加剧

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摘要

Despite agreement that early-onset schizophrenia is continuous with the adult-onset form, quantitative relationships between antipsychotic exposure and clinical response are relatively unexplored in adolescents, compared to adults. Clinical efficacy data from second-generation antipsychotic development programs (N = 5951 adults and N = 1035 adolescents ranging from 12 to 17 years old) were collected from available new drug applications submitted to the US Food and Drug Administration from 1993 to 2017. The developed disease-drug trial models adequately predicted the longitudinal trend in total positive and negative syndrome scale scores in both adults and adolescents using a Weibull placebo response, time-delayed drug effect, and a Weibull structural dropout model. Maximum drug effect was similar between the two populations and was estimated to be between a range of 5% to 11% in adults and 5% to 7% in adolescents. Half maximal effective concentration parameter estimates also indicated similar exposure-response relationships in adults and adolescents across all 4 antipsychotics.Simulated adolescent data using final model parameter estimates from the adult model were in agreement with adolescent observations. This analysis confirms similarity in exposure-response for efficacy and could expedite the development of second-generation antipsychotics for adolescents.
机译：尽管一致认为早发性精神分裂症与成人起病形式是连续的，但与成人相比，青少年中抗精神病药物暴露与临床反应之间的定量关系尚未得到探索。从1993年至2017年提交给美国食品和药物管理局的现有新药申请中收集了第二代抗精神病药物开发项目（N=5951名成年人和N=1035名12至17岁青少年）的临床疗效数据。开发的疾病药物试验模型使用威布尔安慰剂反应、药物延迟效应和威布尔结构退出模型，充分预测了成人和青少年总阳性和阴性综合征量表得分的纵向趋势。两组人群的最大药物效应相似，估计成人的最大药物效应在5%到11%之间，青少年的最大药物效应在5%到7%之间。一半最大有效浓度参数估计值还表明，在所有4种抗精神病药物中，成人和青少年的暴露-反应关系相似。使用成人模型的最终模型参数估计值模拟的青少年数据与青少年观察结果一致。该分析证实了暴露反应的相似性，并可能加速青少年第二代抗精神病药物的开发。

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