Application of quality by design to the development of analytical separation methods

Author:

Orlandini Serena,Pinzauti Sergio,Furlanetto Sandra

Publisher

Springer Science and Business Media LLC

Subject

Biochemistry,Analytical Chemistry

Reference47 articles.

1. Pharmaceutical CGMPs for the 21st century – A Risk-Based Approach. Final report (2004) US Food and Drug Administration. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM176374.pdf . Accessed 14 Jun 2012

2. Guidance for Industry. PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (2004) US Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070305.pdf . Accessed 14 Jun 2012

3. Guidance for Industry. Q8(R2) Pharmaceutical Development (2009) US Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf . Accessed 14 Jun 2012

4. ICH Harmonised Tripartite Guideline. Pharmaceutical Development Q8(R2) (2009) International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf . Accessed 14 Jun 2012

5. ICH Harmonised Tripartite Guideline. Quality Risk Management Q9 (2005) International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf . Accessed 14 Jun 2012

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