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.
Read or Download Non-Biological Complex Drugs: The Science and the Regulatory Landscape (AAPS Advances in the Pharmaceutical Sciences Series) PDF
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Additional 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
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