根据建议的溶解规范评估体外溶解数据的统计方法。

IF 1.3 4区医学 Q4 PHARMACOLOGY & PHARMACY

Pharmaceutical Statistics Pub Date : 2024-03-17 DOI:10.1002/pst.2379

Fasheng Li, Beverly Nickerson, Les Van Alstine, Ke Wang

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引用次数: 0

摘要

体外溶出度测试是监管部门要求的固体剂量药物产品的关键质量措施。制定符合药典标准的验收标准是产品申报和批准上市的必要条件。分析溶出度数据、设定规格和可视化结果的统计方法可能因产品要求、公司实践和科学判断而异。本文概括介绍了评估和设定释放和稳定性体外溶出度规格的步骤。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Statistical approaches to evaluate in vitro dissolution data against proposed dissolution specifications.

In vitro dissolution testing is a regulatory required critical quality measure for solid dose pharmaceutical drug products. Setting the acceptance criteria to meet compendial criteria is required for a product to be filed and approved for marketing. Statistical approaches for analyzing dissolution data, setting specifications and visualizing results could vary according to product requirements, company's practices, and scientific judgements. This paper provides a general description of the steps taken in the evaluation and setting of in vitro dissolution specifications at release and on stability.

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来源期刊

Pharmaceutical Statistics 医学-统计学与概率论

CiteScore

2.70

自引率

6.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Pharmaceutical Statistics is an industry-led initiative, tackling real problems in statistical applications. The Journal publishes papers that share experiences in the practical application of statistics within the pharmaceutical industry. It covers all aspects of pharmaceutical statistical applications from discovery, through pre-clinical development, clinical development, post-marketing surveillance, consumer health, production, epidemiology, and health economics. The Journal is both international and multidisciplinary. It includes high quality practical papers, case studies and review papers.