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Adequacy of safety data for regulatory approval of pediatric indication through extrapolation algorithm.

  • Source: Translational & Clinical Pharmacology. Jun2021, Vol. 29 Issue 2, p73-77. 5p.

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Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities.

  • Source: CPT: Pharmacometrics & Systems Pharmacology. Aug2020, Vol. 9 Issue 8, p419-427. 9p.

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Frequentist rules for regulatory approval of subgroups in phase III trials: A fresh look at an old problem.

  • Source: Statistical Methods in Medical Research. Jul2021, Vol. 30 Issue 7, p1725-1743. 19p.

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Academic Journal

The Rise of the Mutants: Obtaining Regulatory Approval for the Release of Genetically Modified Mosquitoes

  • Source: 17 Colum. Sci. & Tech. L. Rev. 292 (2015-2016) / Columbia Science and Technology Law Review, Vol. 17, Issue 2 (Spring 2016), pp. 292-314

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  • 1-10 of  1,388,665 results for ""REGULATORY approval""