Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective

In Japan in October 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) began to receive electronic data in new drug applications (NDAs). These electronic data are useful to conduct regulatory assessment of sponsors’ submissions and contribute to the PMDA's research. In this article, we...

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Detalles Bibliográficos
Autores principales: Sato, M, Ochiai, Y, Kijima, S, Nagai, N, Ando, Y, Shikano, M, Nomura, Y
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5529733/
https://www.ncbi.nlm.nih.gov/pubmed/28568566
http://dx.doi.org/10.1002/psp4.12203
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author Sato, M
Ochiai, Y
Kijima, S
Nagai, N
Ando, Y
Shikano, M
Nomura, Y
author_facet Sato, M
Ochiai, Y
Kijima, S
Nagai, N
Ando, Y
Shikano, M
Nomura, Y
author_sort Sato, M
collection PubMed
description In Japan in October 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) began to receive electronic data in new drug applications (NDAs). These electronic data are useful to conduct regulatory assessment of sponsors’ submissions and contribute to the PMDA's research. In this article, we summarize the number of submissions of quantitative modeling and simulation (M&S) documents in NDAs in Japan, and we describe our current thinking and activities about quantitative M&S in PMDA.
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spelling pubmed-55297332017-08-02 Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective Sato, M Ochiai, Y Kijima, S Nagai, N Ando, Y Shikano, M Nomura, Y CPT Pharmacometrics Syst Pharmacol Perspective In Japan in October 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) began to receive electronic data in new drug applications (NDAs). These electronic data are useful to conduct regulatory assessment of sponsors’ submissions and contribute to the PMDA's research. In this article, we summarize the number of submissions of quantitative modeling and simulation (M&S) documents in NDAs in Japan, and we describe our current thinking and activities about quantitative M&S in PMDA. John Wiley and Sons Inc. 2017-06-01 2017-07 /pmc/articles/PMC5529733/ /pubmed/28568566 http://dx.doi.org/10.1002/psp4.12203 Text en © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Perspective
Sato, M
Ochiai, Y
Kijima, S
Nagai, N
Ando, Y
Shikano, M
Nomura, Y
Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective
title Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective
title_full Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective
title_fullStr Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective
title_full_unstemmed Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective
title_short Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective
title_sort quantitative modeling and simulation in pmda: a japanese regulatory perspective
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5529733/
https://www.ncbi.nlm.nih.gov/pubmed/28568566
http://dx.doi.org/10.1002/psp4.12203
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