An Integrated Process Analytical Technology (PAT) Approach for Process Dynamics-Related Measurement Error Evaluation and Process Design Space Development of a Pharmaceutical Powder Blending Bed-Reference-Cited by-同舟云学术

An Integrated Process Analytical Technology (PAT) Approach for Process Dynamics-Related Measurement Error Evaluation and Process Design Space Development of a Pharmaceutical Powder Blending Bed

Published:2014-07-14 Issue:1 Volume:19 Page:215-226
ISSN:1083-6160
Container-title:Organic Process Research & Development
language:en
Short-container-title:Org. Process Res. Dev.

Author:

Wu Huiquan¹,White Maury¹,Khan Mansoor¹

Affiliation:

1. Division of Product Quality Research (DPQR, HFD-940), Office of Testing and Research (OTR), Office of Pharmaceutical Sciences (OPS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), FDA White Oak Campus Building 64, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States

Funder

U.S. Food and Drug Administration

Publisher

American Chemical Society (ACS)

Subject

Organic Chemistry,Physical and Theoretical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/op500085m

Reference32 articles.

1. FDA Guidance for Industry. Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production, 2006. Available at:http://www.fda.gov/downloads/Drugs/Guidance/Compliance/RegulatoryInformation/Guidances/UCM070287.pdf(accessed on 01/09/ 2014)

2. Developments in the theory of particle mixing

3. Fundamental powder mixing mechanisms

4. The mixing of dry powders

5. Mixing of granular materials in slowly rotated containers

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