Stability

Author:

Burdick Richard K.,LeBlond David J.,Pfahler Lori B.,Quiroz Jorge,Sidor Leslie,Vukovinsky Kimberly,Zhang Lanju

Publisher

Springer International Publishing

Reference46 articles.

1. Allen PV, Dukes GR, Gerger ME (1991) Determination of release limits: a general methodology. Pharm Res 8(9):1210–1213

2. Asmussen S, Stroz D, LeBlond D, Stephens D (2014) Use of a two tiered degree-hour measure for the management of investigational medicinal product over-temperature excursions using mean kinetic temperature (MKT). J Validation Technol 20(1), http://www.ivtnetwork.com/article/use-two-tiered-degree-hour-measure-management-investigational-medicinal-product-over-tempera . Accessed 19 Dec 2016

3. Asmussen S, Stroz D, LeBlond D, Stephens D (2016) Application of a degree-hour approach for the management of over-temperature (OT) excursions for investigational medicinal products (IMPs) and non-investigational medicinal products (NIMPs), submitted for publication

4. Bancroft TA (1964) Analysis and inference for incompletely specified models involving the use of preliminary test(s) of significance. Biometrics 20:427–442

5. Box GEP, Hunter WG, Hunter JS (1978) Statistics for experimenters. Wiley, New York

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