Food Interaction Studies

Key Concepts

• Alternate methods for administration are often needed for solid oral dosage forms, especially for pediatric and geriatric patient groups
• Foods and drinks are often used as taste-masking agents and thus require food studies
• Complex analytical methodology may be needed due to the wide variety of matrices encountered
• Evaluation of functionality after exposure, compared to a control
• Evaluation of the stability of the product in the food or drink under test
• Studies are designed around an understanding of the chemical characteristics of the active and excipient components, as well as the foods/drinks to be evaluated

Available Studies

Services offered at Alcami

• Excellent reputation for responsiveness, problem-solving, and reliable outcomes
• cGMP compliant with robust quality systems and exemplary compliance record
• Onsite XRPD capabilities
• Experience interpreting the general guidance to design food studies for various products
• Scientific expertise to aid in the selection of foods/drinks for regulatory acceptance and technical success
• Expedited services and flexibility to change the project scope, as needed
• Full range of complementary services to support needs