2005 Medicine Pharmaceutical products Safety 
Pharmaceutical Technology
OCTOBER 28, 2022
Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines.
European Pharmaceutical Review
DECEMBER 19, 2023
One example of such a technology is that recently used to convert a commercial tetanus-diphtheria vaccine usually requiring refrigeration at 2-8°C into a room temperature product that is stable and fully‑protective in Guinea pigs after storage at 45°C for 7-12 months. Injection Safety Fact Sheet. Woodhead Publishing. Pages 20-27.
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