Process analytical technology case study part I: Feasibility studies for quantitative near-infrared method development

Author:

Cogdill Robert P.,Anderson Carl A.,Delgado-Lopez Miriam,Molseed David,Chisholm Robert,Bolton Raymond,Herkert Thorsten,Afnán Ali M.,Drennen James K.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Reference30 articles.

1. FDA. PAT—A Framework for Innovative Manufacturing and Quality Assurance, Draft Guidance; 2003.

2. FDA. Guidance Documents, Available at: http://www.fda.gov/cder/guidance/index.htm. Accessed June 20, 2004.

3. Norris KH, Butler WL. Techniques for obtaining absorption spectra on intact biological samples.IRE transactions on bio-medical electronics. July 1961;8:153–157.

4. Williams P, Norris K, eds.Near-Infrared Technology in the Agricultural and Food Industries. St. Paul, MN: American Association of Cereal Chemists; 2001.

5. Ciurczak EW, Torlini RP, Demkowicz MP.Determination of particle size of pharmaceutical raw materials using near-infrared reflectance spectroscopy.Spectroscopy. (Duluth, MN, United States). 1986;1:36–39.

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