Clinical dosage form method

G. E. Ritchie, L. Gehrlein, and E. W. Ciurczak, Simultaneous Development, Validation and Implementation of a Near-Infrared (NIR) Diffuse Reflectance Spectroscopic Identification Method For Pharmaceutically Active And Inactive (Placebo) Clinical Dosage Forms, Proc. PittCon, New Orleans, March, 2000. 

An NIR spectroscopic method to identify pharmaceutically active and inactive (placebo) clinical dosage forms was recently developed.Typically, the dosage form is packaged with its placebo in the same blister pack. The purpose of the NIR identification method was to identify, nondestructively and rapidly, the four forms in the blister pack. The method was developed to create and validate a one-time-use library of the spectra of clinical dosage forms prepared for double-blind clinical trials. 

Ritchie, G. E., Gehrlein, L., and Ciurczak, E. W. Simultaneous development, validation and implementation of a near-infrared (NIR) diffuse reflectance spectroscopic identification method for pharmaceutically active and inactive (placebo) clinical dosage forms. In Pittsburgh Conference of Analytical Chemistry and Applied Spectroscopy, March 2000, New Orleans, LA. 

In Pharmaceutical and Clinical Calculations, second edition, Drs. Mansoor Khan and Indra Reddy have provided a contemporary resource that can help pharmacy students learn the basic principles of how to accurately interpret prescriptions and medication orders, measure, calculate and compound quality dosage forms. In the latter chapters, the student can learn multiple methods to accurately and safely dose patients. The computational methods to accomplish these ends are clearly presented, and the examples used to demonstrate the concepts are relevant to contemporary practice. Pharmacy students will... 

BE studies are recommended when substantial changes in the components or composition and/or method of manufacture for an extended-release drug product occur between the to-be-marketed NDA dosage form and the clinical trial material. 

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