Clinical dosage form

Formulation development, production, and stability testing of clinical dosage form... 

Bulk API synthesis (GMP and non-GMP) and clinical dosage forms development and manufacture... 

Dannenfelser, R.-M., H. He, Y. Joshi, S. Bateman, and A. T. M. Serajuddin. 2004. Development of clinical dosage forms for a poorly water soluble drug I Application of polyethylene glycol-polysorbate 80 solid dispersion carrier systercL Pharm. Sci93 1165-1175. 

Table 1 Blinding techniques for common clinical dosage forms manufactured in the pilot plant Techniques...

Fig. 5 Process map depicting key functional areas and matrix-related activities involved with supplying clinical dosage forms from the pilot plant.

Assay/uniformity of blends Identification of clinical dosage forms... 

Clinical Supplies. A rapidly growing use for NIR is the discrimination between clinical dosage forms and placebos that are made to look identical to them. Normally, unmarked tablets or capsules are arranged in a specific manner in blister packs. The identity of which is the active is kept from both the patient and the attending doctor (thus the term doubleblind ). 

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. 

Dannenfelser R, He H,Joshi Y, Bateman S, and Serajuddin ATM. Development of Clinical Dosage Forms for a Poorly Water Soluble Drug 1 Application of Polyethylene Glycol-Polysorbate 80 Solid Dispersion Carrier System. J Pharm Sd2004 93 1165-1175. 

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. 

C. Analytical Tools for Formulation Support CLINICAL DOSAGE FORMS... 

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