Design Space Definition-Reference-Cited by-同舟云学术

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Design Space Definition

Published:2017-09-08 Issue: Volume: Page:301-318
ISSN:
Container-title:Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
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Author:

Mockus Linas¹,LeBlond David²,Reklaitis Gintaras V.¹,Basu Prabir K.³,Paul Tim⁴,Pease Nathan⁴,Nail Steven L.⁴,Khan Mansoor A.⁵⁶

Affiliation:

1. Davidson School of Chemical Engineering; Purdue University; West Lafayette IN USA

2. Wadsworth IL USA

3. Mt Prospect IL USA

4. Pharmaceutical Development; Baxter Pharmaceutical Solutions, LLC; Bloomington IN USA

5. Rangel College of Pharmacy; Texas A&M University Health Science Center; College Station TX USA

6. Division of Product Quality Research (DPQR, HFD-940), OTR, Office of Pharmaceutical Quality; Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring MD USA

Publisher

John Wiley & Sons, Inc.

Reference16 articles.

1. ICH ICH Harmonised Tripartite Guideline, Pharmaceutical Development: Q8(R2) ICH Geneva 2009

2. Moore , C. Design Space-An FDA Perspective Atlanta 2007

3. The FDA Critical Path Initiative and Its Influence on New Drug Development;Woodcock;Annual Review of Medicine,2008

4. A Bayesian Approach for Multiple Response Surface Optimization in the Presence of Noise Variables;Miró-Quesada;Journal of Applied Statistics.,2004

5. A Posterior Predictive Approach to Multiple Response Surface Optimization;Peterson;Journal of Quality Technology.,2004

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