Review



dermal pbpk modeling platform  (Simcyp)

 
  • Logo
  • About
  • News
  • Press Release
  • Team
  • Advisors
  • Partners
  • Contact
  • Bioz Stars
  • Bioz vStars
    • 90
      Buy from Supplier

    Structured Review

    Simcyp dermal pbpk modeling platform
    Grants (collaborative agreements) on <t> PBPK </t> modeling and simulation approaches for drug products applied on the skin awarded during GDUFA I and II regulatory research and science programs.
    Dermal Pbpk Modeling Platform, supplied by Simcyp, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
    https://www.bioz.com/product/dermal+pbpk+modeling+platform/pmc10196403-0-0-18?v=Simcyp
    Average 90 stars, based on 1 article reviews
    dermal pbpk modeling platform - by Bioz Stars, 2026-07
    90/100 stars

    Images

    1) Product Images from "Mechanistic modeling of drug products applied to the skin: A workshop summary report"

    Article Title: Mechanistic modeling of drug products applied to the skin: A workshop summary report

    Journal: CPT: Pharmacometrics & Systems Pharmacology

    doi: 10.1002/psp4.12893

    Grants (collaborative agreements) on PBPK modeling and simulation approaches for drug products applied on the skin awarded during GDUFA I and II regulatory research and science programs.
    Figure Legend Snippet: Grants (collaborative agreements) on PBPK modeling and simulation approaches for drug products applied on the skin awarded during GDUFA I and II regulatory research and science programs.

    Techniques Used: Biomarker Discovery, Drug discovery, Formulation, Software, In Vitro, Expressing

    Regulatory tasks where dermal PBPK modeling was utilized to support a regulatory assessment that may involve review of ANDA, pre‐ANDA, controlled correspondence, citizen petitions, and other activities over the years 2017 to 2021 (*June 2021). Blue graphs represent the cases where a dermal PBPK modeling and simulation approach was proposed by the applicant and green graphs represent cases where dermal PBPK modeling and simulation approach was developed internally by the FDA. ANDA, Abbreviated New Drug Application; FDA, US Food and Drug Administration; PBPK, physiologically‐based pharmacokinetic.
    Figure Legend Snippet: Regulatory tasks where dermal PBPK modeling was utilized to support a regulatory assessment that may involve review of ANDA, pre‐ANDA, controlled correspondence, citizen petitions, and other activities over the years 2017 to 2021 (*June 2021). Blue graphs represent the cases where a dermal PBPK modeling and simulation approach was proposed by the applicant and green graphs represent cases where dermal PBPK modeling and simulation approach was developed internally by the FDA. ANDA, Abbreviated New Drug Application; FDA, US Food and Drug Administration; PBPK, physiologically‐based pharmacokinetic.

    Techniques Used:



    Similar Products

    dermal pbpk modeling platform  (Simcyp)
    90
    Simcyp dermal pbpk modeling platform
    Grants (collaborative agreements) on <t> PBPK </t> modeling and simulation approaches for drug products applied on the skin awarded during GDUFA I and II regulatory research and science programs.
    Dermal Pbpk Modeling Platform, supplied by Simcyp, used in various techniques. Bioz Stars score: 90/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
    https://www.bioz.com/product/dermal+pbpk+modeling+platform/pmc10196403-0-0-18?v=Simcyp
    Average 90 stars, based on 1 article reviews
    dermal pbpk modeling platform - by Bioz Stars, 2026-07
    90/100 stars
    		  Buy from Supplier

    Image Search Results


    Grants (collaborative agreements) on PBPK modeling and simulation approaches for drug products applied on the skin awarded during GDUFA I and II regulatory research and science programs.

    Journal: CPT: Pharmacometrics & Systems Pharmacology

    Article Title: Mechanistic modeling of drug products applied to the skin: A workshop summary report

    doi: 10.1002/psp4.12893

    Figure Lengend Snippet: Grants (collaborative agreements) on PBPK modeling and simulation approaches for drug products applied on the skin awarded during GDUFA I and II regulatory research and science programs.

    Article Snippet: Development and validation of dermal PBPK modeling platform toward virtual bioequivalence assessment considering population variability , 2014–2018 , Simcyp, Ltd. , 1U01FD005225.

    Techniques: Biomarker Discovery, Drug discovery, Formulation, Software, In Vitro, Expressing

    Regulatory tasks where dermal PBPK modeling was utilized to support a regulatory assessment that may involve review of ANDA, pre‐ANDA, controlled correspondence, citizen petitions, and other activities over the years 2017 to 2021 (*June 2021). Blue graphs represent the cases where a dermal PBPK modeling and simulation approach was proposed by the applicant and green graphs represent cases where dermal PBPK modeling and simulation approach was developed internally by the FDA. ANDA, Abbreviated New Drug Application; FDA, US Food and Drug Administration; PBPK, physiologically‐based pharmacokinetic.

    Journal: CPT: Pharmacometrics & Systems Pharmacology

    Article Title: Mechanistic modeling of drug products applied to the skin: A workshop summary report

    doi: 10.1002/psp4.12893

    Figure Lengend Snippet: Regulatory tasks where dermal PBPK modeling was utilized to support a regulatory assessment that may involve review of ANDA, pre‐ANDA, controlled correspondence, citizen petitions, and other activities over the years 2017 to 2021 (*June 2021). Blue graphs represent the cases where a dermal PBPK modeling and simulation approach was proposed by the applicant and green graphs represent cases where dermal PBPK modeling and simulation approach was developed internally by the FDA. ANDA, Abbreviated New Drug Application; FDA, US Food and Drug Administration; PBPK, physiologically‐based pharmacokinetic.

    Article Snippet: Development and validation of dermal PBPK modeling platform toward virtual bioequivalence assessment considering population variability , 2014–2018 , Simcyp, Ltd. , 1U01FD005225.

    Techniques: