Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis.

@article{Vial2008PharmaceuticalQO,
  title={Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis.},
  author={J{\'e}r{\^o}me Vial and Melanie Veirs Cohen and Patrick Sassiat and Didier Thi{\'e}baut},
  journal={Current medical research and opinion},
  year={2008},
  volume={24 7},
  pages={2019-33}
}
INTRODUCTION The aim of this study was to evaluate the quality of 31 commercially available generic formulations of docetaxel purchased in 14 countries by comparing their docetaxel content, impurity levels and pH versus those of the proprietary product Taxotere (Tx). RESEARCH DESIGN AND METHODS Generic formulations were purchased in 14 countries in Asia, Africa, the Middle East and Latin America. Levels of docetaxel and impurities (chromatographic peaks above 0.05%) were obtained for each… CONTINUE READING