federal_register: 2018-19065

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2018-19065 Physiologically Based Pharmacokinetic Analyses-Format and Content; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Physiologically Based Pharmacokinetic Analyses--Format and Content." This guidance outlines the recommended format and content for a sponsor or applicant to submit physiologically based pharmacokinetic (PBPK) analyses to FDA to support applications including, but not limited to, investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs). This guidance does not address methodological considerations and best practices for the conduct of PBPK modeling and simulation or the appropriateness of PBPK analyses for a particular drug or a drug product. 2018-09-04 2018 9 https://www.federalregister.gov/documents/2018/09/04/2018-19065/physiologically-based-pharmacokinetic-analyses-format-and-content-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2018-09-04/pdf/2018-19065.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Physiologically Based Pharmacokinetic Analyses--Format and Content." This guidance outlines the recommended format and content...  

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