A New Definition of Pharmaceutical Quality: Assembly of a Risk Simulation Platform to Investigate the Impact of Manufacturing/ Product Variabcpility on Clinical Performance-Reference-Cited by-同舟云学术

A New Definition of Pharmaceutical Quality: Assembly of a Risk Simulation Platform to Investigate the Impact of Manufacturing/ Product Variabcpility on Clinical Performance

Published:2010-12 Issue:12 Volume:99 Page:5046-5059
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

SHORT STEVEN M.,COGDILL ROBERT P.,FRANK D’AMICO,DRENNEN JAMES K.,ANDERSON CARL A.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference31 articles.

1. The financial returns of investments in process analytical technology and lean manufacturing: Benchmarks and case study;Cogdill;J Pharm Innov,2007

2. 2004. Pharmaceutical CGMPs for the 21st Century—A risk-based approach final report. Rockville: U.S. Department of Health and Human Services, Food and Drug Administration.

3. The concept of pharmaceutical quality;Woodcock;Am Pharm Rev,2004

4. Risk-based quality by design (QbD): A Taguchi perspective on the assessment of product quality, and the quantitative linkage of drug product parameters and clinical performance;Cogdill;J Pharm Innov,2008

5. A brief introduction to Monte Carlo simulation;Bonate;Clin Pharmacokinet,2001

Cited by 6 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. Using Manufacturing Design Space Concepts for Stability Risk Assessment—Gabapentin NIPTE/FDA Case Study;AAPS PharmSciTech;2018-08-17

2. In vitro model for predicting bioavailability of subcutaneously injected monoclonal antibodies;Journal of Controlled Release;2018-03

3. Characteristics of product recalls of biopharmaceuticals and small-molecule drugs in the USA;Drug Discovery Today;2016-04

4. Development of Tablets;Therapeutic Delivery Solutions;2014-08-22

5. Content uniformity testing: suitability of different approaches for marketed low dose tablets;Pharmaceutical Development and Technology;2012-02-13