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The number of unauthorised and unregulated online outlets selling counterfeit pharmaceuticalproducts is continuously growing, with many selling counterfeit medications via the internet typically posing as legitimate vendors. Counterfeit medicines and medical supplies can also cause significant harm to people, the report said.
Patents are often described as the ‘lifeblood’ of pharmaceutical companies. 1 However, patent protection for pharmaceuticalproducts is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. 26 April, 2016.
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.
TRS 953 – Annex 2, Appendix 1: Stability testing of active pharmaceutical ingredients and finished pharmaceuticalproducts: Stability conditions for WHO Member States by Region. I Woodhead Publishing Series in Food Science, Technology and Nutrition, Maillard Reactions in Chemistry, Food and Health. Woodhead Publishing.
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).
Q8(R2) Pharmaceutical Development. International Council for Harmonisation (ICH), 2005. Q10 Pharmaceutical Quality System. Q12 Technical and Regulatory Considerations for PharmaceuticalProduct Lifecycle Management. Q13 Continuous Manufacturing of Drug Substances and Drug Products.
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