| Since the 505(b)(2) process is relatively new to | | | | previously submitted data to regulatory authorities |
| pharmaceutical companies and in fact, is still evolving at | | | | worldwide. |
| the FDA, one component of the regulatory clinical | | | | To achieve and ensure quality clinical data, |
| submission is a must in this process and that is a | | | | pharmaceutical companies must invest time and a |
| bridging study. Pharmaceutical companies often ask, | | | | budget to enlist a team of highly experienced clinical |
| what is a bridging study and why is it pivotal as it | | | | data controllers and data managers, "data |
| pertains to the 505(b)(2) regulatory clinical submission | | | | gate-keepers". The time and costs involved are |
| process? | | | | minimal when considering and understanding the |
| A bridging study is a Phase 1 study and is used to | | | | advantages of data that is quality controlled and |
| compare the systemic levels of the drug(s) between | | | | pristine. As a result of data integrity, pharmaceutical |
| the proposed drug product and the reference product. | | | | companies will not have to engage in long question and |
| If properly performed and completed, a bridging study | | | | answer periods pre-filing or post-filing, curious lack of |
| allows a pharmaceutical companies to reference the | | | | data integrity, under reporting of adverse events and |
| safety, efficacy and tolerance data that is already | | | | otherwise. |
| known from the original regulatory clinical submission. In | | | | Poor quality clinical data can lead to regulatory clinical |
| fact, the key pivotal difference between a 505(b)(1) or | | | | submission and clinical study being put on hold, a RTF |
| a 505(b)(2) regulatory clinical submission is exactly the | | | | (Refusal to File) and regulatory action letter(s) that are |
| "bridging study". | | | | unfavorable to the drug, the data and the |
| Always remember, whatever regulatory clinical | | | | pharmaceutical companies and the overall approval, |
| process used, data integrity and quality controlled data | | | | with a large negative bottom line impact the |
| is essential. Therefore, when using the 505(b)(1) or | | | | pharmaceutical company sponsoring the clinical |
| 505(b)(2) regulatory clinical submission process, all data | | | | submission. Investing in a bridging study using careful |
| must be quality controlled, concise, accurate, statistically | | | | quality control can help avoid these poor outcomes. |
| and clinically significant and must be consistent with | | | | |