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Related Experiment Videos

Purity as an issue in pharmaceutical research and development

M Bauer1, L de Leede, M Van Der Waart

  • 1Sanofi, 195 route d'Espagne, 31036 Toulouse Cedex, France.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|October 31, 1998
PubMed
Summary

This conference highlighted strategies for pharmaceutical purity, covering R&D specifications, physical properties like polymorphism, and unique challenges in biotechnological products to ensure drug safety and regulatory compliance.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Development
  • Regulatory Affairs

Background:

  • The third EUFEPS Nuremberg Conference addressed critical aspects of pharmaceutical purity.
  • Key discussions focused on establishing robust specifications throughout the research and development (R&D) lifecycle.
  • Emphasis was placed on safety evaluations and regulatory perspectives from industry experts.

Framework:

  • Strategies for setting R&D specifications were presented, including an industrial approach.
  • The physical aspects of purity, such as polymorphism and crystallinity, were explored, stressing early-phase R&D integration.
  • Regulatory considerations, including potential bioequivalence studies, were discussed.

Implementation:

  • The unique challenges of biotechnological products regarding impurity limits were examined.

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  • Production methods for biotechnological products require careful review to ensure purity.
  • The conference reviewed the progress of International Council for Harmonisation (ICH) guidelines.

    • Implications:

    • Establishing clear purity specifications is crucial for drug safety and regulatory approval.
    • Understanding and controlling physical properties early in R&D mitigates risks.
    • Harmonized guidelines are essential for global pharmaceutical development and patient safety.