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Master Thesis

Validation analytique : application de la procédure SFSTP 2003-2006 au domaine de la phytothérapie

Abstract : Analytical control of a medicinal product before its release on the market is an important and necessary step to guarantee the quality of the product that is going to be delivered to patients. Pharmaceutical laboratories are required to prove that analytical procedures used for this control are highly valid and reliable, by performing an analytical validation. The use of accuracy profile based on tolerance interval as decision tool for validation is a procedure developed by a SFSTP commission, published in 2003 and 2006 in STP Pharma Pratiques guides. This decision tool allows to anticipate the guarantee that a given proportion of future results obtained with the procedure will be within pre-established acceptability limits. This thesis provides a practical application of the procedure published by SFSTP in 2003 and 2006 using accuracy profile, to the analytical validation of products with very specific characteristics and up to now neglected of validation guides: herbal medicinal products, or HMPs.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01188779
Contributor : Bu Carreire Université de Bordeaux <>
Submitted on : Monday, August 31, 2015 - 3:04:01 PM
Last modification on : Wednesday, August 23, 2017 - 4:33:57 PM
Long-term archiving on: : Tuesday, December 1, 2015 - 10:40:24 AM

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  • HAL Id : dumas-01188779, version 1

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Isabelle Pinguet. Validation analytique : application de la procédure SFSTP 2003-2006 au domaine de la phytothérapie. Sciences pharmaceutiques. 2015. ⟨dumas-01188779⟩

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