Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy

Samtani Mahesh N.; Nandy Partha; Ravenstijn Paulien; Remmerie Bart; Vermeulen An; Russu Alberto; Dhoore Peter; Baum Ellen Z.; Savitz Adam; Gopal Srihari; Hough David

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Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy

机译：前药剂量选择和帕潘立酮棕榈酸酯的3个月制剂开发，采用药理学架桥策略

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AimsTo prospectively select the dose of the paliperidone palmitate 3-month (PP3M) formulation, using a pharmacometric bridging strategy based on the paliperidone palmitate 1-month (PP1M) formulation previously approved for schizophrenia treatment.

机译：目的使用基于先前批准用于精神分裂症治疗的帕潘立酮棕榈酸酯1个月（PP1M）制剂的药理学桥接策略，前瞻性选择帕潘立酮棕榈酸酯3个月（PP3M）制剂的剂量。

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《British Journal of Clinical Pharmacology》 |2016年第5期|共7页
作者
Samtani Mahesh N.; Nandy Partha; Ravenstijn Paulien; Remmerie Bart; Vermeulen An; Russu Alberto; Dhoore Peter; Baum Ellen Z.; Savitz Adam; Gopal Srihari; Hough David;
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正文语种 eng
中图分类药理学;
关键词
paliperidone palmitate; pharmacometric bridging; prospective validation;

机译：帕潘立酮棕榈酸酯;药理学桥接;前瞻性验证;
入库时间 2022-08-18 09:14:12

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1. Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy [J] . Samtani Mahesh N., Nandy Partha, Ravenstijn Paulien, British Journal of Clinical Pharmacology . 2016,第5期

机译：前药剂量选择和帕潘立酮棕榈酸酯的3个月制剂开发，采用药理学架桥策略
2. Prospective dose selection and acceleration of paliperidone palmitate 3‐month formulation development using a pharmacometric bridging strategy [J] . Samtani Mahesh N., Nandy Partha, Ravenstijn Paulien, British journal of clinical pharmacology . 2016,第5期

机译：使用药理学桥接策略选择帕潘立酮棕榈酸酯的预期剂量并加速3个月制剂开发
3. Dosing and Switching Strategies for Paliperidone Palmitate 3-Month Formulation in Patients with Schizophrenia Based on Population Pharmacokinetic Modeling and Simulation, and Clinical Trial Data [J] . Magnusson Mats O., Samtani Mahesh N., Plan Elodie L., CNS drugs . 2017,第4期

机译：基于人口药代动力学建模和仿真的精神分裂症患者的Paliperidone棕榈酸棕榈酸棕榈酸棕榈酸酯的给药和切换策略，以及临床试验数据
4. The development of a "holistic" model incorporating business strategy formulation with IdM strategy formulation [C] . C.J. (Neels) Kruger, M. N. Mama Americas conference on information systems;AMCIS 2010 . 2011

机译：结合业务战略制定和IdM战略制定的“整体”模型的开发
5. Development of novel spray coated soft elastic gelatin capsule sustained release formulations of nifedipine, bioavailability and bioequivalence of verapamil HCL controlled release formulations, pharmacokinetics of terbinafine after single oral doses in raptors. [D] . Fahmy, Sahar Abd El-Sattar. 2004

机译：硝苯地平新型喷雾包衣的软弹性明胶胶囊缓释制剂的开发，维拉帕米盐酸盐控释制剂的生物利用度和生物等效性，在猛禽中单次口服剂量后特比萘芬的药代动力学。
6. Prospective dose selection and acceleration of paliperidone palmitate 3‐month formulation development using a pharmacometric bridging strategy [O] . Mahesh N. Samtani, Partha Nandy, Paulien Ravenstijn, 2016

机译：使用药理学桥接策略选择帕潘立酮棕榈酸酯的预期剂量并加速3个月制剂开发
7. Effect of Paliperidone Palmitate 3-Month Formulation on Goal Attainment and Disability After 52 Weeks’ Treatment in Patients with Clinically Stable Schizophrenia [O] . Martin Lambert, Pedro Sanchez, Paul Bergmans, 2020

机译：Paliperidone Palmitate 3月制定对临床稳定精神分裂症患者52周治疗后目标达到和残疾的影响

Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy

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