A state of the art in analytical quality-by-design and perspectives in characterization of nano-enabled medicinal products

Author:

Bastogne Thierry,Caputo Fanny,Prina-Mello Adriele,Borgos Sven,Barberi-Heyob Muriel

Funder

European Commission

Horizon 2020

Horizon 2020 Framework Programme

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference61 articles.

1. Challenges of clinical translation in nanomedicine: a qualitative study;Satalkar;Nanomed. Nanotechnol. Biol. Med.,2016

2. Committee for Human Medicinal Products, ICH Topic Q2 (R1) Validation of Analytical Procedures, Note for Guidance, European Medicine Agency, 1995.

3. Committee for Human Medicinal Products, ICH Topic Q1A (R2) Stability Testing of new Drug Substances and Products, Note for Guidance, European Medicine Agency, 2003.

4. Committee for Human Medicinal Products, ICH Topic Q1B Photostability Testing of New Active Substances and Medicinal Products, Note for Guidance, European Medicine Agency, 1998.

5. Committee for Human Medicinal Products, ICH Topic Q3A (R2) Impurities in new Drug Substances, Note for Guidance, European Medicine Agency, 2006.

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