April 2023-Volume 113-Issue 4（2023年4月第113卷第4期）
https://ascpt.onlinelibrary.wiley.com/toc/15326535/2023/113/4

      Editorial（社论）
      1. 改进精神病学治疗方法的蕈形体
    （Mush Room for Improving Therapeutic Approaches in Psychiatry）
      作者：Piet H. van der Graaf (Certara, UK)

       Perspectives（观点）
      1. 2016-2021年人工智能和机器学习在药品开发监管申报中的应用前景分析
    （Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021）
      作者：Qi Liu,  Hao Zhu* (Office of Clinical Pharmacology, Center for Drug Evaluation and Research, FDA, USA)

       White Paper（白皮书）
      1. 人类ADME战略和设计范式转变的考虑因素——行业白皮书
    （Considerations for Human ADME Strategy and Design Paradigm Shift(s) – An Industry White Paper）
      作者：Graeme C. Young (GlaxoSmithKline Research & Development Ltd., UK)

       Reviews（综述）
      1. PharmVar基因聚焦：SLCO1B1
    （PharmVar GeneFocus: SLCO1B1）
      作者：Laura B. Ramsey, Andrea Gaedigk* (Divisions of Clinical Pharmacology and Research in Patient Services, USA; School of Medicine, University of Missouri–Kansas City, Missouri, USA)

      2. 利用临床药理学数据评估胰岛素产品的生物相似性和互换性
    （Leveraging Clinical Pharmacology Data to Assess Biosimilarity and Interchangeability of Insulin Products）
      作者：Jayabharathi Vaidyanathan (Office of Clinical Pharmacology, Center of Drug Evaluation and Research, FDA, USA)

      3. 药物基因组临床决策支持：范围界定综述
    （Pharmacogenomic Clinical Decision Support: A Scoping Review）
      作者：D. Max Smith (Georgetown University Medical Center, USA)

      4. 利福平药物-药物-相互作用研究：关于亚硝胺杂质问题的思考
    （Rifampin Drug–Drug–Interaction Studies: Reflections on the Nitrosamine Impurities Issue）
      作者：Aernout van Haarst(Celerion, Scientific Affairs, UK)

      Research（研究）
      1. 健康受试者口服西洛昔宾的药代动力学和药效学
    （Pharmacokinetics and Pharmacodynamics of Oral Psilocybin Administration in Healthy Participants）
      作者：Friederike Holze, Matthias E. Liechti* (Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel and University of Basel, Switzerland)

      2. 从电子免费文本注释到基于索赔的药物流行病学研究的混杂调整的可扩展特征工程
    （Scalable Feature Engineering from Electronic Free Text Notes to Supplement Confounding Adjustment of Claims-Based Pharmacoepidemiologic Studies）
      作者：Richard Wyss, Kueiyu Joshua Lin* (Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, USA)

      3. 瑞桑吉单抗在活动性克罗恩病患者中的有效性和安全性的人群药代动力学和暴露-反应分析
    （Population Pharmacokinetic and Exposure–Response Analyses for Efficacy and Safety of Risankizumab in Patients With Active Crohn's Disease）
      作者：Ahmed Abbas Suleiman, Yinuo Pang* (Clinical Pharmacology, AbbVie Deutschland GmbH & Co KG, Germany; Clinical Pharmacology, AbbVie Inc,USA)

      4. 定义二线免疫疗法对IMpower131研究生存结果影响的多状态药效学模型
    （Multistate Pharmacometric Model to Define the Impact of Second-Line Immunotherapies on the Survival Outcome of the IMpower131 Study）
      作者：Sreenath M. Krishnan, Mats O. Karlsson* (Department of Pharmacy, Uppsala University, Sweden)

      5. 大型上市后心脏代谢试验后安全性相关药物标签的变化：欧洲公共评估报告综述
    （Safety-Related Drug Label Changes Following Large Post-Marketing Cardiometabolic Trials: A Review of European Public Assessment Reports）
      作者：Viktoriia Starokozhko, Peter G.M. Mol* (Dutch Medicines Evaluation Board, The Netherlands; Department of Clinical Pharmacy and Pharmacology, University of Groningen, The Netherlands)

      6. 肿瘤学中混合对照臂模拟随机对照试验的案例研究
    （Emulating Randomized Controlled Trials with Hybrid Control Arms in Oncology: A Case Study）
      作者：Sanhita Sengupta, Katherine Tan* (Bristol Myers Squibb, USA;Flatiron Health, Inc., USA)

      7. 预测骨关节炎患者的治疗反应：两项III期他尼珠单抗随机临床试验的结果
    （Predicting Treatment Responses in Patients With Osteoarthritis: Results From Two Phase III Tanezumab Randomized Clinical Trials）
      作者：Luana Colloca(Department of Pain and Translational Symptom Science, Placebo Beyond Opinions Center, School of Nursing, University of Maryland, USA)

      8. 冠心病和他汀类药物相关肌肉症状患者骨骼肌和血液中的阿托伐他汀代谢产物模式
    （Atorvastatin Metabolite Pattern in Skeletal Muscle and Blood from Patients with Coronary Heart Disease and Statin-Associated Muscle Symptoms）
      作者：Trine Lauritzen (Department of Medicine, Vestre Viken Trust, Drammen Hospital, Norway.)

      9. 使用干血斑改善PrEP依从性监测的新算法
    （A Novel Algorithm to Improve PrEP Adherence Monitoring Using Dried Blood Spots）
      作者：Aaron S. Devanathan, Mackenzie L. Cottrell* (University of North Carolina Eshelman School of Pharmacy, USA)

      10. 缓解转换C5抑制剂的阵发性睡眠性血红蛋白尿症患者的药物-靶点-药物复合物
    （Mitigating Drug–Target–Drug Complexes in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Switch C5 Inhibitors）
      作者：Jun-ichi Nishimura (Department of Hematology and Oncology, Graduate School of Medicine, Faculty of Medicine, Osaka University, Japan)

      11. 甲氨蝶呤诱导类风湿性关节炎患者肝损伤的全基因组关联研究
    （Genome-wide Association Study of Methotrexate-Induced Liver Injury in Rheumatoid Arthritis Patients）
      作者：Frank Eektimmerman, Henk-Jan Guchelaar* (Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, The Netherlands)

      12. 基于日本MID-NET的真实世界数据描述甲状腺功能亢进患者与噻吗唑相关的粒细胞减少症
    （Characterizing Granulocytopenia Associated with Thiamazole in Patients with Hyperthyroidism Based on Real-World Data from the MID-NET in Japan）
      作者：Yuki Kinoshita, Yoshiaki Uyama* (Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency, Japan)