Testing the Fit of Regression Models Estimated with Extremely Small Samples: Application in Pharmaceutical Stability Studies

Pharmaceutical stability studies are conducted to estimate the shelf life, i.e. period during which drug product maintains its identity and stability. In evaluation of process, regression curve is fitted on data obtained study life determined using curve. The process suggested by ICH considers only case true relationship between measured attribute time being linear. However, no method for practitioner decide if linear model appropriate their dataset. This a major problem, as falsely selected may distort estimated great extent, resulting in unreliable quality control. difficulty misspecification detection that very few observations available. conventional methods applied verification might not be or efficient due small sample size. this paper, problem addressed some developed proposed detect misspecification. can any where estimation performed independent samples. Besides studies, frequently construction single calibration curves an analytical measurement another applied. It shown our statistically them have high efficiency when simulated situations resemble pre-approval post-approval studies.