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Prescription to OTC Switch Programs
Overview |
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- Can consumers self-diagnose the illness?
- Can consumers comprehend the label and understand the warnings?
- Can consumers use the product without medical supervision?
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These questions must be answered for any product to be approved for over-the counter (OTC) use. When clinical and marketing groups within pharmaceutical companies determine that an established prescription product should be converted to OTC status, a significant amount of clinical and technical development work must be conducted. The aims of these programs are significantly different from traditional clinical trials for NDA submission, since the consumer, not the patient, is the focus.
One of Covance's specialty areas is prescription to over-the-counter (Rx to OTC) switch studies. In Rx to OTC switch studies, Covance gathers the necessary safety, efficacy and self-diagnosis data to obtain regulatory permission for the sale of a drug product without the need of a prescription. Covance will assist you in the design and conduct of studies for OTC candidates. In planning for studies involving OTC candidates, the following must be considered: |
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| Unique toxicities |
Literature for possible OTC labeling claims |
| Margin of safety |
Minimally effective dose |
| Safety profile in large populations |
Possible drug or food interactions |
| Safety profile when used at high |
Warnings |
| World-wide drug experience |
Full assessment of pharmacodynamics |
| Risk-benefit analysis |
Extensive pharmacokinetic analysis |
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| Covance will evaluate these and other needs for OTC switch programs. We will work with you to optimize your product's potential so that you gain competitive advantage while balancing critical clinical concerns. |
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