**Author details**

Alina Porfire\*, Marcela Achim, Cristina Barbalata, Iulia Rus, Ioan Tomuta and Cecilia Cristea Faculty of Pharmacy, University of Medicine and Pharmacy "Iuliu Hatieganu", Cluj Napoca, Romania

\*Address all correspondence to: aporfire@umfcluj.ro

© 2019 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

**85**

*Pharmaceutical Development of Liposomes Using the QbD Approach*

2009. Available from: https://www.ich. org/fileadmin/Public\_Web\_Site/ICH\_ Products/Guidelines/Quality/Q8\_R1/ Step4/Q8\_R2\_Guideline.pdf [Accessed

[10] Raman NVVSS, Mallu UR, Bapatu HR. Analytical quality by design approach to test method development and validation in drug substance manufacturing. Journal of Chemistry.

[11] Pramod K, Tahir MA, Charoo NA, Ansari SH, Ali J. Pharmaceutical product development: A quality by design approach. International Journal of Pharmaceutical Investigation.

[12] Chowdary KPR, Shankar KR, Kumar PS. Recent research on QbD approach in formulation development – A review. International Journal of Computer Science Trends and Technology. 2014;**4**(1):282-292

[13] Yu LX. Pharmaceutical quality by design: Product and process development, understanding, and control. Pharmaceutical Research.

[14] Sylvester B, Porfire A, Muntean DM, Vlase L, Banciu M, Luput L, et al. Optimzation of prednisoloneloaded long-circulating liposomes via application of Quality by Design (QbD) approach. Journal of Liposome

SS. Application of quality by design approach to optimize process and formulation parameters of rizatriptan loaded chitosan nanoparticles. Journal of Advanced Pharmaceutical Technology

[16] De Beer TR, Wiggenhorn M, Hawe A, Kasper JC, Almeida A, Quinten T,

Research. 2018;**28**(1):49-61

[15] Shirsat AE, Chitlange

& Research. 2015;**6**(3):88-96

01-2019]

2015;**2015**:1-8

2016;**6**(3):129-138

2008;**25**(4):781-791

*DOI: http://dx.doi.org/10.5772/intechopen.85374*

[1] Rayaprolu BM. Quality by design: A brief introduction. Journal of Pharmacovigilance. 2015;**3**(4):e142

[2] Tefas LR, Rus LM, Achim M, Vlase L, Tomuta I. Application of the quality by design concept in the development of quercetin-loaded polymeric nanoparticles. Farmácia.

[3] Sangshetti JN, Deshpande M, Zaheer Z, Shinde DB, Arote R. Quality by design approach: Regulatory need. Arabian Journal of Chemistry.

[4] Lionberger RA, Lee SL, Lee L, Raw A, Yu LX. Quality by design: Concepts for ANDAs. The AAPS Journal.

[5] Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, et al. Understanding pharmaceutical quality by design. The AAPS Journal. 2014;**16**(4):771-783

[6] The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines [Internet]. 2019. Available from: https:// www.ich.org/products/guidelines/ quality/article/quality-guidelines.html

[7] FDA Guidances [Internet]. 2019. Available from: https://www.fda.gov/ Drugs/GuidanceComplianceRegulatory Information/Guidances%20/default.htm

[8] EMA Reflection Paper: Chemical, pharmaceutical and biological

information to be included in dossiers when Process Analytical Technology (PAT) is employed [Internet]. 2006. Available from: http://www.ema.europa. eu/docs/en\_GB/document%20\_library/ Other/2009/10/WC500004890.pdf

[9] ICH harmonised tripartite guideline. Pharmaceutical development Q8(R2).

2018;**66**(5):798-810

2017;**10**:S3412-S3425

2008;**10**(2):268-276

**References**

*Pharmaceutical Development of Liposomes Using the QbD Approach DOI: http://dx.doi.org/10.5772/intechopen.85374*
