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Toward Good Simulation Practice

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The term GxP indicates a collection of good practices, e.g., quality guidelines, to ensure
that a product is safe and meets its intended use. The most important examples of GxP
in biomedicine are Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
The GLP are curated by the Organisation for Economic Co-operation and Development
(OECD); they provide “a managerial quality control system covering the organisational
process and the conditions under which non-clinical health and environmental studies
are planned, performed, monitored, recorded, reported, and retained (or archived)”.1 The
International Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH) curates the GCP. GCP provides an international ethical and scientific quality standard for clinical trials to facilitate the regulatory authorities’ mutual
acceptance of clinical evidence in the various ICH regions. GxP guidelines are available

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Detail Information

Series Title

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Call Number

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Publisher

: Springer Cham., 2024

Collation

X, 144

Language

English

ISBN/ISSN

9783031482847

Classification

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Content Type

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Media Type

computer

Carrier Type

online resource

Edition

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Subject(s)

Toward Good
Simulation Practice

Specific Detail Info

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Statement of Responsibility

Marco Viceconti, Luca Emili

Other Information

Cataloger

angga

Source

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Validator

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Digital Object Identifier (DOI)

https://link.springer.com/book/10.1007/978-3-031-48284-7

Journal Volume

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Journal Issue

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Subtitle

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Parallel Title

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