Impurity investigations by phases of drug and product development

Author:

Olsen Bernard A.,Sreedhara Alavattam,Baertschi Steven W.

Publisher

Elsevier BV

Subject

Spectroscopy,Analytical Chemistry

Reference54 articles.

1. ICH Q3A(R2) Impurities in New Drug Substances; ICH Q3B(R2) Impurities in New Drug Products; ICH Q3C(R6) Impurities: guideline for Residual Solvents; ICH Q3D Guideline For Elemental Impurities; http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html, accessed 19, August 2017.

2. Guidance for Industry CGMP for Phase 1 Investigational Drugs,2008

3. INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information,2003

4. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials, Draft;EMA,2016

5. ICH Q8(R2) Pharmaceutical Development; ICH Q9 Quality Risk Management; ICH Q10 Pharmaceutical Quality System; http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html, accessed 19, August 2017.

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