Formulation of generic products

Generic product is well-defined as a drug product that is comparable to branded innovator product in dosage form, strength, route of administration, quality and performance characteristics and intended use. Preformulations are classified into fundamental, derived and compatibility studies. For generic product compatibility studies are most important preformulation study. Many pre-formulation studies should be performed nevertheless generic product can be considered a duplicate of the innovator product. There is a difference in the material properties of the API and excipients used by innovator and generic manufacturer can knowingly affect performance of the dosage form. Therefore, it is important to perform preformulation studies for generic products.

  • Track 1-1 Quality Assurance
  • Track 2-2 Quality control
  • Track 3-3 Formulation R&D
  • Track 4-4 Intellectual property rights
  • Track 5-5 Preformulation studies
  • Track 6-6 Stability studies

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