CoDevelopment After Drug Approval

In those cases in which the drug approval is not contingent upon the use of the diagnostic or when changes in drug labeling for improving safety or effectiveness profiles are being requested, studies may be performed during phase

IV drug studies or at any interval following drug approval (e.g., postmarket commitments). In some cases, prospective studies may be needed; in others, use of banked samples from prospective studies, retrospective studies, and/or cross-sectional studies may be sufficient to support diagnostic claims.

If it is not possible to conduct coordinated studies of the drug and diagnostic, the phase III clinical trial may represent the only opportunity available to obtain and bank prospectively collected samples for future diagnostic test study. Particular attention should be paid to ensuring that samples are collected properly with appropriate informed consent to support future bridging studies (e.g., platform change), diagnostic studies, and evaluation of the analyte of interest. The samples collected should be banked in storage conditions that maintain sample integrity. Concerns about any bias, missing samples, or selection in accrual of banked samples should be addressed appropriately.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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