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[46] did not estimate a sample size required for a study of this nature (a survey study). [48] In response, Schultz [49] stated that, given that calculating a studys appropriate sample size requires some foreknowledge of the size of the expected effect, the appropriate sample size could not have been calculated prior to initiation of the study

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But now, as the FDA officially lifts that shortage, the foundation of this business model is crumbling, exposing a series of legal, ethical, and operational challenges that may have been overlooked from the start by those who dont live and breathe drug development