Quality-By-Design (QbD): An Integrated Approach for Evaluation of Powder Blending Process Kinetics and Determination of Powder Blending End-point

Author:

Wu Huiquan,Khan Mansoor A.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference32 articles.

1. Sampling practices in powder blending;Muzzio;Int J Pharm,1997

2. FDA,2004.Guidance for Industry, PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. Available at: http://www/fda.gov/cder/guidance/6419fnl.pdf.

3. FDA/ICH,2006.Guidance for Industry. Q8 Pharmaceutical Development. Available at:http://www.fda.gov/cder/guidance/6746fnl.pdf.

4. FDA/ICH,2006.Guidance for Industry. Q9 Quality Risk Management. Available at:http://www.fda.gov/cder/guidance/7153fnl.pdf.

5. Process control perspective for process analytical technology: Integration of chemical engineering practice into semiconductor and pharmaceutical industries;Wu;Chem Eng Commun,2007

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