Evaluating Current Practices in Shelf Life Estimation

Author:

Capen Robert,Christopher David,Forenzo Patrick,Huynh-Ba Kim,LeBlond David,Liu Oscar,O’Neill John,Patterson Nate,Quinlan Michelle,Rajagopalan Radhika,Schwenke James,Stroup Walter

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Reference6 articles.

1. Capen R, Christopher D, Forenzo F, Ireland C, Liu O, Lyapustina S, et al. On the shelf life of pharmaceutical products. AAPS PharmSciTech. 2012;13(3):911–8.

2. Anonymous. Stability Testing of New Drug Substances and Products Q1A(R2) Step 4. In International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2003. Available from URL: http://www.ich.org . Last accessed 21 Sep 2017.

3. Anonymouse. Evaluation of Stability Data Q1E Step 4. In International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. 2003. Available from URL: http://www.ich.org . Last accessed 21 Sep 2017.

4. Kiermeier A, Jarrett R, Verbyla A. A new approach to estimating shelf-life. Pharm Stat. 2004;3:3–11.

5. Quinlan M, Stroup W, Schwenke J, Christopher D. Evaluating the performance of the ICH guidelines for shelf life estimation. J Biopharm Stat. 2013;23(4):881–96.

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