• GMP Issues with Emphasis on Dissolution Testing

  • Identifying Sources of Error in Sample Testing and Calibration

  • Pellicle Formation/Cross-Linking of Gelatin Capsules

  • Calibration and Validation of Dissolution Equipment Including Non-Compendial Equipment

  • Semi Automation and Full Automation of the Dissolution Lab: Pros and Cons

  • Challenges of Developing Discriminating Methods for Poorly Soluble Drugs and Special Dosage Forms

  • Method Development, Including Comparators, Suspensions, Special Dosage Forms, Liquid-Filled Capsules

  • A Practical Approach to IVIVC

  • Overview/Historical Perspective of Dissolution Testing

  • Interactions with Formulators, PK, QA, Metrology, Other Sites

  • Special Considerations for Each Phase of Development

  • QC Test versus Surrogate

  • Method Transfer

  • Current Regulatory Updates

  • Biopharmaceutics Classification System Extensions

  • Specification Setting, Including AAPS/FDA Specification Workshop

  • USP Initiatives

  • Basic Dissolution Testing

  • Validation of Dissolution Methods

  • Fiber Optics

  • Analytical Issues
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