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Quality by design with a focus on biosimilars

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.

Manufacturing 52
Manufacturing Safety Medicine Pharmaceutical products 52
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The imperative of fridge-free vaccines

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.

Distribution 101
Distribution Manufacturing Food Specialization 101
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