STABILITY TESTING GUIDELINES OF PHARMACEUTICAL PRODUCTS

Comparison of endotoxin testing methods for pharmaceutical products.

Bioluminescence for USP sterility testing of pharmaceutical suspension products.

Bioluminescence measurement significantly improved the accuracy, sensitivity, precision, and reliability of the current visual endpoint determination for the USP sterility test and eliminated the day 7 transfer/dilution step required for testing suspension products. Thirteen strains of bacteria and fungi (representing potential contaminants in sterile products), three pharmaceutical suspension ...

Comparison of two guidelines on immunotoxicity testing of medicinal products.

Despite the lack of formal immunotoxicity testing guidelines, the assessment of immune function has been a routine component of toxicity testing for over twenty years. The European Agency for the Evaluation of Medicinal Products (EMEA) and The US Food and Drug Administration (FDA) have recently adopted new guidelines for immunotoxicity testing of new medicinal products. These two guidelines are...

Roughness Model for Adhesion Testing of Pharmaceutical Coating Materials

Objective Roughness is the main parameter in interlocking bonding mechanism. Yet there is no model designed to evaluate the effect of surface roughness on adhesion of coating materials in pharmaceutical sciences. Materials and Methods In this study polymethyl metacrylate spherical beads with different sizes were poured into 10 mm mold, then it was pressed by hand screw and finally heated to 141...

British Pharmaceutical Products