This would require a new licensing application, including conducting of new manufacturing validation studies; and pre-clinical and clinical studies.

这将需要提出新的许可申请，包括开展新的生产验证研究，以及临床前和临床研究。

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This PICOT format provides key words for a literature search of pre-appraised evidence and original research studies that address the clinical scenario.

PICOT格式为评价前的证据和包含临床实践问题的原文的检索提供了关键词。

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After completion of more pre-clinical studies, Short hopes to file Diversa's first investigational new drug application sometime next year.

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According to the company, Nucryst has seen encouraging pre-clinical results in studies looking at the efficacy of NP 32101 for treating inflammatory bowel disease, including ulcerative colitis.

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