2005 Pharmaceutical products Safety 
Pharmaceutical Technology
OCTOBER 28, 2022
Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products. Following QbD to guarantee a drug product's safety.
European Pharmaceutical Review
DECEMBER 19, 2023
TRS 953 – Annex 2, Appendix 1: Stability testing of active pharmaceutical ingredients and finished pharmaceutical products: Stability conditions for WHO Member States by Region. Injection Safety Fact Sheet. Woodhead Publishing. Pages 20-27. ISBN 9781855737921. Higashiyama T. Novel functions and applications of trehalose.
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