Linear model applied to the evaluation of pharmaceutical stability data

Renato Cesar Souza, Jaqueline Raminelli

Abstract


The expiry date on the packaging of a product gives the consumer the confidence that the product will retain its identity, content, quality and purity throughout the period of validity of the drug. The definition of this term in the pharmaceutical industry is based on stability data obtained during the product registration. By the above, this work aims to apply the linear regression according to the guideline ICH Q1E, 2003, to evaluate some aspects of a product undergoing in a registration phase in Brazil. With this propose, the evaluation was realized with the development center of a multinational company in Brazil, with samples of three different batches composed by two active principal ingredients in two different packages. Based on the preliminary results obtained, it was possible to observe the difference of degradation tendency of the product in two different packages and the relationship between the variables studied, added knowledge so new models of linear equations can be applied and developed for other products.


Keywords


Linear equation model; stability study; medicines registration; expiration date



DOI: http://dx.doi.org/10.5433/1679-0375.2013v34n1p57

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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Semin., Ciênc. Exatas Tecnol.
Londrina - PR - Brazil
E-ISSN: 16790375
DOI: 10.5433/1679-0375
Email: seminaexatas@uel.br
 
This journal is licensed with a license Creative Commons Attribution-NonCommercial 4.0 International.