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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. QbD principles are woven into regulatory guidance documents, primarily guidances Q8 to Q11 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Manufacturing 52
Manufacturing Safety Medicine Pharmaceutical products 52
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Pharma within planetary boundaries

European Pharmaceutical Review

APRIL 21, 2023

4 Together with a legal expert from the Bucerius Law School Hamburg, we looked at the legal and political frameworks that could enable the German pharmaceutical sector to become more sustainable. Climate-conscious prescription of inhaled medicinal products. Internet] NHS England. cited 23Apr]. Available from: [link].

Pharma 81
Pharma Food and Drug Administration Medicine Pharmaceutical 81
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