Détails Publication
Incorporating batch effects in the estimation of drug stability parameters using an Arrhenius model,
Discipline: Sciences pharmaceutiques
Auteur(s): I T Some, P Bogaerts, R Hanus, M Hanocq, J Dubois
Auteur(s) tagués: SOME Touridomon Issa
Renseignée par : SOME Touridomon Issa
Résumé

The nonlinear estimation of drug stability parameters (energy of activation E a and shelf-life t Y) by conventional approaches employs equations relating drug content determination C at time t and temperature T. The identification procedures lead to the determination of only one initial drug content C 0 for several different experiments. However, it is well known that because of experimental concentration variation or of intentional modification of the experimental schedule, there are as many initial drug contents as experiments. For these reasons, a method which takes into account batch effects is proposed to determine stability parameters and also all initial drug contents C 0j where j is the index of experiment in one step. This method is more accurate from a statistical viewpoint and is suitable for data treatment in pharmaceutical industries where the initial drug content of each batch …

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