5. Appendice

Table 7 is taken from the WHO classification and tables 8 and 9 are taken from ICH guidelines – Q1

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Appendice

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Glossary

Bibliography

(1) - PELLERIN (F.), CHANON (N.) - La réactivité des molécules organiques au service des études de stabilité. - Sci. Techn. Pharm. T, 10, 8 (1981).
(2) - GRIMM (W.) - Storage conditions for stability testing. -...

Websites

ICH (International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use) https://www.ich.org

EMA (European Medicines Agency) https://www.ema.europa.eu

WHO (World Health Organization)

Theses

DURAFOUR (P.-A.) – The importance of stability studies in the pharmaceutical field. University of Lyon 1 (2020).

SCODELLARO (A.) – Review of the stability study process in the pharmaceutical industry: from regulation to implementation to exploitation of observed trends. University of Rouen (2013).

SECRETAN (P.-H.) – Characterization of degradation processes of novel anticoagulants...