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Updated: Jun 24, 2025

A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
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A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development

Published on: February 11, 2019

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一种儿科药物产品的加速预测稳定性研究,用于补充新的药物应用

Viktoria Rakers1, Jin Wang2, Dawen Kou3

  • 1Small Molecule Analytical Research and Development, F. Hoffmann-La Roche AG, Basel, Switzerland.

AAPS PharmSciTech
|June 6, 2024
PubMed
概括

两个加速稳定性评估计划 (ASAP) 研究优化了儿科药物配方的稳定性. 成功的ASAP模型预测了药物稳定性,以减少长期数据支持监管提交.

关键词:
加快稳定性评估计划 (ASAP) 是指加速预测稳定性的加速预测稳定性数据不连续性数据不连续性新药应用程序 新药应用程序儿科药物产品是儿童药物产品.

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