By Daan J.A. Crommelin,Jon S. B. de Vlieger

The upward push of bio- and nano-technology within the final many years has ended in the emergence of a brand new and distinct kind of medication often called non-biological advanced medicines (NBCDs). This e-book illustrates the demanding situations linked to NBCD improvement, in addition to the complexity of assessing the results of producing adjustments on innovator and follow-on batches of NBCDs. It additionally touches upon confirmed advertising authorization necessities for biosimilars that may be powerful in comparing follow-on NBCDs, together with an illustration of regulate over the producing strategy and a necessity for specific physico-chemical characterization and (pre)clinical tests.

This booklet is intended for use for future years as a customary reference paintings for the advance of NBCDs. furthermore, this e-book goals to stimulate discussions and extra our pondering to make sure that judgements concerning the approval of complicated medications are made with correct medical facts at the desk.

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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


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