Quality of biotechnological products: stability testing of biotechnological/biological products. Annex to the ICH Harmonised Tripartite Guideline for the Stability Testing of New Drug Substances and Products.

@article{Niazi1998QualityOB,
  title={Quality of biotechnological products: stability testing of biotechnological/biological products. Annex to the ICH Harmonised Tripartite Guideline for the Stability Testing of New Drug Substances and Products.},
  author={Sarfaraz Niazi},
  journal={Developments in biological standardization},
  year={1998},
  volume={93},
  pages={
          211-9
        }
}
Additional Notes This note for guidance concerns the application of Part 2, sections C and F of the Annex to Directive 75/318/EEC as amended, with a view to the granting of a marketing authorisation for a new medicinal product of biological or biotechnological origin. It is an annex to the Stability Testing of New Active Substances and Medicinal Products guideline which should be consulted for basic principles. 

Topics from this paper.

Similar Papers

Loading similar papers…