A brief review on application of design of experiment for the analysis of pharmaceuticals using HPLC

Author:

Patil Sachin D.,Chalikwar Shailesh S.ORCID

Publisher

Elsevier BV

Subject

Pharmaceutical Science,Pharmacology

Reference128 articles.

1. Understanding pharmaceutical quality by design;Yu;AAPS J,2014

2. Design of experiments (DoE) applied to pharmaceutical and analytical quality by design (QbD);Isa Martins;Braz J Pharm Sci,2018

3. Quality by design (QbD) in analytical sciences: an overview;Bhutani;Pharma Times,2014

4. ICH guideline Q14 on analytical procedure development (Draft). https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q14-analytical-procedure-development-step-2b_en.pdf.

5. ICH guideline Q2(R2) on validation of analytical procedures (Draft). https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r2-validation-analytical-procedures-step-2b_en.pdf.

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