The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Physiologically Based Pharmacokinetic Analyses--Format and Content.'' This guidance recommends to drug sponsors the format and content for submitting physiologically based pharmacokinetic (PBPK) analyses to FDA to enable efficient and consistent review.
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Physiologically Based Pharmacokinetic Analyses-Format and Content; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Physiologically Based Pharmacokinetic Analyses--Forma...
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81 FR 87043
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“Physiologically Based Pharmacokinetic Analyses-Format and Content; Draft Guidance for Industry; Availability,” thefederalregister.org (December 2, 2016), https://thefederalregister.org/documents/2016-28971/physiologically-based-pharmacokinetic-analyses-format-and-content-draft-guidance-for-industry-availability.