Using accelerated drug stability results to inform long-term studies in shelf life determination

التفاصيل البيبلوغرافية
العنوان: Using accelerated drug stability results to inform long-term studies in shelf life determination
المؤلفون: John W. Seaman, James D. Stamey, Paul Faya
المصدر: Statistics in Medicine. 37:2599-2615
بيانات النشر: Wiley, 2018.
سنة النشر: 2018
مصطلحات موضوعية: Statistics and Probability, Epidemiology, Computer science, business.industry, media_common.quotation_subject, Stability (learning theory), Regression analysis, Shelf life, 030226 pharmacology & pharmacy, 01 natural sciences, Term (time), Reliability engineering, 010104 statistics & probability, 03 medical and health sciences, 0302 clinical medicine, Drug development, Prior probability, Quality (business), 0101 mathematics, business, media_common, Pharmaceutical industry
الوصف: In the pharmaceutical industry, the shelf life of a drug product is determined by data gathered from stability studies and is intended to provide consumers with a high degree of confidence that the drug retains its strength, quality, and purity under appropriate storage conditions. In this paper, we focus on liquid drug formulations and propose a Bayesian approach to estimate a drug product's shelf life, where prior knowledge gained from the accelerated study conducted during the drug development stage is used to inform the long-term study. Classical and nonlinear Arrhenius regression models are considered for the accelerated conditions, and two examples are given where posterior results from the accelerated study are used to construct priors for a long-term stability study.
تدمد: 0277-6715
DOI: 10.1002/sim.7663
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::fdc8064eb1e1456cf1fa55fa783857d0
https://doi.org/10.1002/sim.7663
Rights: CLOSED
رقم الانضمام: edsair.doi...........fdc8064eb1e1456cf1fa55fa783857d0
قاعدة البيانات: OpenAIRE
الوصف
تدمد:02776715
DOI:10.1002/sim.7663