By Daan J.A. Crommelin,Jon S. B. de Vlieger
The upward thrust of bio- and nano-technology within the final many years has ended in the emergence of a brand new and specific form of drugs often called non-biological complicated medicinal drugs (NBCDs). This ebook illustrates the demanding situations linked to NBCD improvement, in addition to the complexity of assessing the results of producing alterations on innovator and follow-on batches of NBCDs. It additionally touches upon confirmed advertising and marketing authorization requisites for biosimilars that may be potent in comparing follow-on NBCDs, together with an indication of keep an eye on over the producing approach and a necessity for specified physico-chemical characterization and (pre)clinical tests.
This publication is intended for use for future years as a regular reference paintings for the improvement of NBCDs. furthermore, this e-book goals to stimulate discussions and additional our considering to make sure that judgements in regards to the approval of advanced medications are made with appropriate medical information at the desk.
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Extra info for Non-Biological Complex Drugs: The Science and the Regulatory Landscape (AAPS Advances in the Pharmaceutical Sciences Series)
Non-Biological Complex Drugs: The Science and the Regulatory Landscape (AAPS Advances in the Pharmaceutical Sciences Series) by Daan J.A. Crommelin,Jon S. B. de Vlieger