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White Papers / Tech Papers

The Importance of Food Studies in Pharmaceutical Development

Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients.

Released By Alcami Corporation

Alcami’s scientists have substantial experience designing and executing food studies that comply with the highest quality standards, which have expedited formulation selection and regulatory approval for a variety of pharmaceutical dosage forms.

Why are Food Studies needed?
 
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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