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 distinctive form of drugs referred to as non-biological advanced medications (NBCDs). This e-book illustrates the demanding situations linked to NBCD improvement, in addition to the complexity of assessing the consequences of producing adjustments on innovator and follow-on batches of NBCDs. It additionally touches upon confirmed advertising authorization standards for biosimilars that may be potent in comparing follow-on NBCDs, together with an illustration of regulate over the producing strategy and a necessity for unique physico-chemical characterization and (pre)clinical tests.
This e-book is intended for use for years yet to come as a regular reference paintings for the improvement of NBCDs. in addition, this publication goals to stimulate discussions and additional our pondering to make sure that judgements concerning the approval of complicated medicines are made with suitable medical information at the desk.
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Additional resources 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