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Over-Encapsulation: Common Questions And Challenges

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White Paper: Over-Encapsulation: Common Questions And Challenges

Today's clinical trial professional finds the need to perform a greater number of comparator trials than ever before. The increase in the number of trials, however, can not be allowed to affect the aggressive timelines of clinical trials nor allow quality to be compromised. The double-blind, placebo-controlled clinical trial remains the highest standard to guard against bias based compromise of a clinical trial. Thus, the clinical trial professional must find a more efficient way of performing double-blind placebo-controlled clinical trials without compromise of integrity.

Over-encapsulation is now recognized as a truly viable method of blinding products for clinical trials. Use of encapsulation allows comparator studies to be performed without the delay associated with obtaining placebo matching samples. While encapsulation is a well recognized method, a few common questions remain in the mind of the clinical professional. Perhaps the most common concern of over-encapsulation is whether the gelatin shell will affect the dissolution profile of the product it contains.

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White Paper: Over-Encapsulation: Common Questions And Challenges

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