Food & Drug Interaction Studies
- 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 Food & Drug Interaction 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
Food Interaction Studies 101
Take a closer look at Food Studies through this informative blog post
Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients. Geriatric, pediatric, and patients suffering from gastroesophageal reflux disease are often administered pharmaceuticals mixed with food or liquids due to difficulty swallowing tablets or capsules. For immediate release, enteric-coated, modified release, or extended-release dosage forms, a food study is required to evaluate whether the alternate route of administration impacts the therapeutic dose.
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