Patient-Centric Quality Standards

Author:

Mire-Sluis Anthony,Dobbins John,Moore Christine M.V.,Pepper Teresa,Rellahan Barbara,Riker Ken,Roberts Matthew,Schultz Thomas

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference48 articles.

1. US FDA. Final Report, Pharmaceutical CGMPs for the 21st Century – A Risk-Based Approach. Sept. 2004. Available at: https://www.USFDA.gov/media/77391/download. Accessed January 10, 2024.

2. US FDA. Final Report FDA-EMA pilot program for the parallel assessment of quality-by-design elements of marketing applications. April 2007. Available at: https://www.USFDA.gov/drugs/pharmaceutical-quality-resources/final-report-USFDA-ema-pilot-program-parallel-assessment-quality-design-elements-marketing. Accessed January 10, 2024.

3. International Committee for Harmonization. Guideline Database. Available at: https://ich.org/.

4. International Committee for Harmonization. Quality Guidelines. Available at: https://ich.org/page/quality-guidelines. Accessed January 10, 2024.

5. International Committee for Harmonization. Q8(R2): Pharmaceutical Development. Aug. 2009. Available at: https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf.

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