PQLI Application of Science- and Risk-based Approaches (ICH Q8, Q9, and Q10) to Existing Products-Reference-Cited by-同舟云学术

PQLI Application of Science- and Risk-based Approaches (ICH Q8, Q9, and Q10) to Existing Products

Published:2009-03 Issue:1 Volume:4 Page:4-23
ISSN:1872-5120
Container-title:Journal of Pharmaceutical Innovation
language:en
Short-container-title:J Pharm Innov

Author:

Potter Chris

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1007/s12247-009-9051-9.pdf

Reference13 articles.

1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Quality Risk Management Q9, Step 4, 9-November-2005.

2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Pharmaceutical Quality System Q10, Step 4, 4-June-2008.

3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Pharmaceutical Development Q8 (R1), Step 4, November 2008.

4. Nosal R, Schultz T. PQLI Definition of Criticality. J Pharm Innov 2008;3:69–78.

5. Lepore J, Spavins J. PQLI Design Space. J Pharm Innov 2008;3:79–87.

Cited by 33 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. Current Approaches to Design Space Development and Regulatory Applications for Drug Products: Findings from the IQ Utilization of Design Space for Filings Working Group Survey;Pharmaceutical Research;2024-09-04

2. Statistical data treatment for residence time distribution studies in pharmaceutical manufacturing;International Journal of Pharmaceutics;2024-05

3. Quality By Design in Quality Assurance;Introduction to Quality by Design (QbD);2024

4. Real-Time Monitoring of Integrated Continuous Granulation/Drying Line System “Lavortex®” for the Pharmaceutical Manufacturing of Acetaminophen Oral Dosage Formulations Using Near-Infrared Spectroscopy;2024

5. Using residence time distribution in pharmaceutical solid dose manufacturing – A critical review;International Journal of Pharmaceutics;2021-12