JVT

General Considerations for Dissolution Methods: Development, Validation, and Transfer | IVT

KEY POINTS

The following key points are discussed:

  • The dissolution method is important because it is the only test that addresses product performance.
  • Dissolution methods may be used for different purposes, and the method development process should address these specific goals.
  • The validity of the dissolution test must be demonstrated. This is generally accomplished by examining the ruggedness of the method and conducting a series of validation experiments.
  • Because the implications of a failing dissolution result can be huge, it is important to have a rugged method with appropriate discriminating power.
  • Changes encountered during the product lifecycle may present challenges to the ongoing validity of the method. These include changes to both the drug product and the testing laboratory.

Download "General Considerations for Dissolution Methods: Development, Validation, and Transfer"




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