Setting the control limit at release for stability assurance-Reference-Cited by-同舟云学术

登录注册会员服务联系我们

Setting the control limit at release for stability assurance

Published:2022-08-17 Issue:1 Volume:22 Page:45-63
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Chen X. Gregory¹^ORCID,van der Vaart A. W.²^ORCID

Affiliation:

1. Biostatistics and Research Decision Sciences MSD Zurich Switzerland

2. Delft Institute of Applied Mathematics TU Delft Delft The Netherlands

Funder

Nederlandse Organisatie voor Wetenschappelijk Onderzoek

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2259

Reference14 articles.

1. Q8(R2)

2. ICH Q6A Specifications

3. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products;World Health Organization;WHO Tech Rep Ser,2009

4. Understanding internal release limits;Altan S;Pharm Freeze Dry Technol,2018

Cited by 1 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Drug Shelf Life and Release Limits Estimation Based on Manufacturing Process Capability;Pharmaceutics;2023-03-26

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线，采集、加工和组织学术论文而形成的新型学术文献查询和分析系统，可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容，当前同舟云学术共收录了国内外主流学术期刊6万余种，收集的期刊论文及会议论文总量共计约1.5亿篇，并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询！咨询电话：010-8811{复制后删除}0370

www.globalauthorid.com

TOP