Purity as an issue in pharmaceutical research and development.
In the third EUFEPS Nuremberg Conference, three important aspects in the purity area were extensively covered. The first one dealt with the setting up of practical strategies to establish specifications during the complete R&D process. An industrial strategy on how this goal could be reached was presented. A safety evaluation aspect reflecting the discussion between ten pharmaceutical companies was given and the regulatory point of view was presented. The second one focused on the physical aspect of the purity issue (polymorphism, crystallinity...). The scientific background of this problem was presented and the necessity to cover this problem during the early phases of an industrial R&D project was outlined. Regulatory aspects were covered and the necessity to perform in certain cases bioequivalence studies was pointed out. The last session raised the particularity of biotechnological products. The contributors stressed that the impurity limits should be based on safety evaluation as well as the necessity to review carefully the production methods. Finally, a review was done on the current progress of the ICH guidelines establishment.
Bauer
M
M
Sanofi, 195 route d'Espagne, 31036 Toulouse Cedex, France.
de Leede
L
L
Van Der Waart
M
M
D001709:Biotechnology; D002626:Chemistry, Pharmaceutical / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000302:isolation & purification / Q000592:standards*; D012106:Research / Q000592:standards*; D014116:Toxicology
D004364:Pharmaceutical Preparations