Friday, October 23, 2009

505(b)(2), Importance of a Bridging Study

Since the 505(b)(2) process is relatively new to pharma and in fact, is still evolving at the FDA, one component of the regulatory clinical submission is a must in this process and that is a bridging study.

Pharma often ask, what is a bridging study and why is it pivotal as it pertains to the 505(b)(2) regulatory clinical submission process?

A bridging study, is a Phase 1 study and is used to compare the systemic levels of the drug(s) between the proposed drug product and the reference product. If properly performed and completed, a bridging study allows a pharma company to reference the safety, efficacy and tolerance data that is already known from the original regulatory clinical submission.

In fact, the key pivotal difference between a 505(b)(1) or a 505(b)(2) regulatory clinical submission is exactly the "bridging study".

Always remember, whatever regulatory clinical process used, data integrity and quality controlled data is essential. Therefore, when using the 505(b)(1) or 505(b)(2) regulatory clinical submission process, all data must be quality controlled, concise, accurate, statistically and clinically significant and must be consistent with previously submitted data to regulatory authorities worldwide.

To achieve and ensure quality clinical data, pharma must invest time and a budget to enlist a team of highly experienced clinical data controllers and data managers, "data gate-keepers".

The time and costs involved are minimal when considering and understanding the advantages of data that is quality controlled and pristine. As a result of data integrity, pharma will not have to engage in long question and answer periods pre-filing or post-filing, curious lack of data integrity, under reporting of adverse events and otherwise. The otherwise can lead to regulatory clinical submission and clinical study holds, a RTF and regulatory action letter(s) that are unfavorable to the drug, the data, the pharma and the overall approval.

Remember, always quality control your data.

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