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Pharmaceutical stability testing conference.

Li Shi1, Timothy Schofield

  • 1Merck & Co., Inc.

Expert Opinion on Drug Safety
|March 10, 2004
PubMed
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This conference focused on pharmaceutical stability testing for drug development and commercialization. Experts discussed stability challenges for small molecules and biopharmaceuticals across all development stages.

Area of Science:

  • Pharmaceutical Science
  • Drug Development
  • Biopharmaceutical Stability

Background:

  • The SMi Pharmaceutical Stability Testing conference (September 8-9, 2003, London) addressed critical stability issues.
  • Focused on both compound drugs and biopharmaceuticals, impacting product lifecycle.
  • Highlighted the importance of stability testing in pharmaceutical product development and commercialization.

Framework:

  • Presentations covered stability testing from early preclinical through late-stage regulatory filing.
  • Addressed biologicals and small molecules, encompassing drug substance and drug product.
  • Incorporated case studies to illustrate practical applications and challenges.

Implementation:

  • Gathered formulation, process, analytical, quality, and regulatory professionals.

Related Experiment Videos

  • Facilitated knowledge exchange between European and US pharmaceutical industry experts.
  • Provided insights into navigating regulatory requirements for stability data.

    • Implications:

    • Enhanced understanding of stability testing strategies for diverse pharmaceutical products.
    • Informed approaches to mitigate risks and ensure product quality and efficacy.
    • Contributed to optimizing pharmaceutical development and regulatory submission processes.