New Dosage Forms

In a clinical development program, initially one lead dosage form is typically taken through full development. The chosen form usually represents the most easily developed, stable and marketable form that is suitable for adults. For some products, the initial form is found to be suboptimal and alternative forms are introduced early in the clinical development process. For other products, the need for multiple forms is not recognized until future competitors are found to have a more acceptable or a unique formulation that may lead to a greater market share.

In other cases, a new dosage formulation is required to satisfy a new market segment. Oral solutions and chewable tablets are beneficial for a pediatric population. A slow-release preparation (such as percutaneous patches) may be preferred in elderly patients taking multiple drugs if it allows once-daily (or less frequent) dosing. Trials demonstrating safety and efficacy of new formulations are often conducted in Phase IV and typically act as the supporting information for an sNDA.

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