Assessment of Applications of Design of Experiments in Pharmaceutical Development for Oral Solid Dosage Forms

Author:

Bai Ge,Chen Zhijin,Raines Kimberly,Chen Hansong,Dave Kaushalkumar,Lin Ho-Pi,Zolnik Banu S.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science

Reference13 articles.

1. Lionberger RA, Lee SL, Lee LM, Raw A, Yu LX. Quality by design: concepts for ANDAs. AAPS J. 2008;10(2):268–76.

2. ICH_Expert_Working_Group. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use: pharmaceutical development Q8(R2) 2009. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf. Acceessed 10 July 2019.

3. ICH Quality Implementation Working Group. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use: Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers (R4) 2010. Available from:http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_9_10_QAs/Q-IWG_Q_A_R4_Step4_Nov.2010.pdf. Accessed 10 July 2019.

4. Quality_Implementation_Working_Group. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use: Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers (R4) 2010. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_9_10_QAs/Q-IWG_Q_A_R4_Step4_Nov.2010.pdf.

5. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, et al. Understanding pharmaceutical quality by design. AAPS J. 2014;16(4):771–83.

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